[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Rules and Regulations]
[Pages 1262-1331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33174]



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Part III





Department of Health and Human Services





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45 CFR Part 170



Establishment of the Permanent Certification Program for Health 
Information Technology; Final Rule

Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Rules 
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 170

RIN 0991-AB59


Establishment of the Permanent Certification Program for Health 
Information Technology

AGENCY: Office of the National Coordinator for Health Information 
Technology, Department of Health and Human Services.

ACTION: Final rule.

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SUMMARY: This final rule establishes a permanent certification program 
for the purpose of certifying health information technology (HIT). This 
final rule is issued pursuant to the authority granted to the National 
Coordinator for Health Information Technology (the National 
Coordinator) by section 3001(c)(5) of the Public Health Service Act 
(PHSA), as added by the Health Information Technology for Economic and 
Clinical Health (HITECH) Act. The permanent certification program will 
eventually replace the temporary certification program that was 
previously established by a final rule. The National Coordinator will 
use the permanent certification program to authorize organizations to 
certify electronic health record (EHR) technology, such as Complete 
EHRs and/or EHR Modules. The permanent certification program could also 
be expanded to include the certification of other types of HIT.

DATES: These regulations are effective February 7, 2011. The 
incorporation by reference of certain publications listed in the rule 
is approved by the Director of the Federal Register as of February 7, 
2011.

FOR FURTHER INFORMATION CONTACT: Steven Posnack, Director, Federal 
Policy Division, Office of Policy and Planning, Office of the National 
Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

Acronyms

APA Administrative Procedure Act
ARRA American Recovery and Reinvestment Act of 2009
CAH Critical Access Hospital
CCHIT Certification Commission for Health Information Technology
CGD Certification Guidance Document
CHPL Certified Health Information Technology Products List
CMS Centers for Medicare & Medicaid Services
CORE Committee on Operating Rules for Information Exchange[supreg]
CAQH Council for Affordable Quality Healthcare
EHR Electronic Health Record
FACA Federal Advisory Committee Act
FFP Federal Financial Participation
FFS Fee for Service (Medicare Program)
HHS Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
HIT Health Information Technology
HITECH Health Information Technology for Economic and Clinical 
Health
ILAC International Laboratory Accreditation Cooperation
ISO International Organization for Standardization
IT Information Technology
LAP Laboratory Accreditation Program
MA Medicare Advantage
MRA Mutual/Multilateral Recognition Arrangement
NIST National Institute of Standards and Technology
NPRM Notice of Proposed Rulemaking
NVCASE National Voluntary Conformity Assessment System Evaluation
NVLAP National Voluntary Laboratory Accreditation Program
OIG Office of Inspector General
OMB Office of Management and Budget
ONC Office of the National Coordinator for Health Information 
Technology
ONC-AA ONC-Approved Accreditor
ONC-ACB ONC-Authorized Certification Body
ONC-ATCB ONC-Authorized Testing and Certification Body
OPM Office of Personnel Management
PHSA Public Health Service Act
RFA Regulatory Flexibility Act
RIA Regulatory Impact Analysis
SDO Standards Development Organization
SSA Social Security Act

Table of Contents

I. Background
    A. Previously Defined Terminology
    B. Legislative and Regulatory History
    1. Legislative History
    a. Standards, Implementation Specifications, and Certification 
Criteria
    b. Medicare and Medicaid EHR Incentive Programs
    i. Medicare EHR Incentive Program
    ii. Medicaid EHR Incentive Program
    c. HIT Certification Programs
    2. Regulatory History and Related Guidance
    a. Initial Set of Standards, Implementation Specifications, and 
Certification Criteria Interim and Final Rules
    b. Medicare and Medicaid EHR Incentive Programs Proposed and 
Final Rules
    c. HIT Certification Programs Proposed Rule and the Temporary 
and Permanent Certification Programs Final Rules
    d. Recognized Certification Bodies as Related to the Physician 
Self-Referral Prohibition and Anti-Kickback EHR Exception and Safe 
Harbor Final Rules
II. Overview of the Permanent Certification Program
III. Provisions of the Permanent Certification Program; Analysis of 
and Response to Public Comments on the Proposed Rule
    A. Overview
    B. Scope and Applicability
    C. Definitions
    1. Day or Days
    2. Applicant
    3. ONC-ACB
    4. ONC-AA
    D. ONC-AA Status, Ongoing Responsibilities and Reconsideration 
of Request for ONC-AA Status
    1. ONC-AA Status
    2. On-going Responsibilities
    3. Reconsideration of Request for ONC-AA Status
    E. Correspondence
    F. Certification Options for ONC-ACBs
    1. Distinction Between Testing and Certification
    2. Types of Certification
    a. Complete EHRs for Ambulatory or Inpatient Settings
    b. Integrated Testing and Certification of EHR Modules
    G. ONC-ACB Application Process
    1. Application
    2. Principles of Proper Conduct for ONC-ACBs
    a. Maintain Accreditation
    b. ONC Visits to ONC-ACB Sites
    c. Lists of Certified Complete EHRs and EHR Modules
    i. ONC-ACB Lists
    ii. Certified HIT Products List
    d. Records Retention
    e. NVLAP-Accredited Testing Laboratory
    i. Separation of Testing and Certification
    ii. Accreditation, Test Tools and Test Procedures, and ONC-ACBs' 
Permitted Reliance on Certain Test Results
    f. Surveillance
    g. Refunds
    h. Suggested New Principles of Proper Conduct
    3. Application Submission
    4. Overall Application Process
    H. ONC-ACB Application Review, Reconsideration, and ONC-ACB 
Status
    1. Application Review
    2. Application Reconsideration
    3. ONC-ACB Status
    I. Certification of Complete EHRs, EHR Modules and Other Types 
of HIT
    1. Complete EHRs
    2. EHR Modules
    a. Applicable Certification Criterion or Criteria
    b. Privacy and Security Certification
    c. Identification of Certified Status
    3. Other Types of HIT
    J. Certification of ``Minimum Standards''
    K. Authorized Certification Methods
    L. Good Standing as an ONC-ACB, Revocation of ONC-ACB Status, 
and Effect of Revocation on Certifications Issued by a Former ONC-
ACB
    1. Good Standing as an ONC-ACB
    2. Revocation of ONC-ACB Status
    3. Effect of Revocation on Certifications Issued by a Former 
ONC-ACB
    M. Dual-Accredited Testing and Certification Bodies
    N. Concept of ``Self-Developed''
    O. Validity of Complete EHR and EHR Module Certification and 
Expiration of Certified Status
    P. Differential or Gap Certification

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    Q. Barriers to Entry for Potential ONC-ACBs and an ONC-Managed 
Certification Process
    R. General Comments
    S. Comments Beyond the Scope of This Final Rule
IV. Provisions of the Final Regulation
V. Collection of Information Requirements
    A. Collection of Information: Required Documentation for 
Requesting ONC-Approved Accreditor Status Under the Permanent 
Certification Program
    B. Collection of Information: Application for ONC-ACB Status 
Under the Permanent Certification Program
    C. Collection of Information: ONC-ACB Collection and Reporting 
of Information Related to Complete EHR and/or EHR Module 
Certifications
    D. Collection of Information: Records Retention Requirements
    E. Collection of Information: Submission of Surveillance Plan 
and Surveillance Results
VI. Regulatory Impact Analysis
    A. Introduction
    B. Why this Rule is Needed?
    C. Executive Order 12866--Regulatory Planning and Review 
Analysis
    1. Comment and Response
    2. Executive Order 12866 Final Analysis
    a. Permanent Certification Program Estimated Costs
    i. Request for ONC-AA Status
    ii. Application Process for ONC-ACB Status
    iii. Testing and Certification of Complete EHRs and EHR Modules
    iv. Costs for Collecting, Storing, and Reporting Certification 
Results
    v. Costs for Retaining Certification Records
    vi. Submission of Surveillance Plan and Surveillance Results
    vii. Overall Average Annual Costs by Entity
    b. Permanent Certification Program Benefits
    D. Regulatory Flexibility Act
    E. Executive Order 13132--Federalism
    F. Unfunded Mandates Reform Act of 1995

I. Background

A. Previously Defined Terminology

    In addition to the new terms and definitions created by this rule, 
the following terms have the same meaning as provided at 45 CFR 
170.102.
    <bullet> Certification criteria
    <bullet> Certified EHR Technology
    <bullet> Complete EHR
    <bullet> Day or days
    <bullet> Disclosure
    <bullet> EHR Module
    <bullet> Implementation specification
    <bullet> Qualified EHR
    <bullet> Standard
    The definition of the term ONC-Authorized Testing and Certification 
Body (ONC-ATCB) can be found at 45 CFR 170.402.

B. Legislative and Regulatory History

1. Legislative History
    The HITECH Act, Title XIII of Division A and Title IV of Division B 
of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 
111-5), was enacted on February 17, 2009. The HITECH Act amended the 
PHSA and created ``Title XXX--Health Information Technology and 
Quality'' (Title XXX) to improve health care quality, safety, and 
efficiency through the promotion of HIT and electronic health 
information exchange. Section 3001 of the PHSA establishes the Office 
of the National Coordinator for Health Information Technology (ONC). 
Title XXX of the PHSA provides the National Coordinator for Health 
Information Technology (the National Coordinator) and the Secretary of 
Health and Human Services (the Secretary) with new responsibilities and 
authorities related to HIT. The HITECH Act also amended several 
sections of the Social Security Act (SSA) and in doing so established 
the availability of incentive payments to eligible professionals and 
eligible hospitals to promote the adoption and meaningful use of 
Certified EHR Technology. References to ``eligible hospitals'' in this 
final rule shall mean ``eligible hospitals and/or critical access 
hospitals'' unless otherwise indicated.
a. Standards, Implementation Specifications, and Certification Criteria
    With the passage of the HITECH Act, two new Federal advisory 
committees were established, the HIT Policy Committee and the HIT 
Standards Committee (sections 3002 and 3003 of the PHSA, respectively). 
Each is responsible for advising the National Coordinator on different 
aspects of standards, implementation specifications, and certification 
criteria. The HIT Policy Committee is responsible for, among other 
duties, recommending priorities for the development, harmonization, and 
recognition of standards, implementation specifications, and 
certification criteria, while the HIT Standards Committee is 
responsible for recommending standards, implementation specifications, 
and certification criteria for adoption by the Secretary under section 
3004 of the PHSA consistent with the ONC-coordinated Federal Health IT 
Strategic Plan.
    Section 3004 of the PHSA defines how the Secretary adopts 
standards, implementation specifications, and certification criteria. 
Section 3004(a) of the PHSA defines a process whereby an obligation is 
imposed on the Secretary to review standards, implementation 
specifications, and certification criteria and identifies the 
procedures for the Secretary to follow to determine whether to adopt 
any group of standards, implementation specifications, or certification 
criteria included among National Coordinator-endorsed recommendations.
b. Medicare and Medicaid EHR Incentive Programs
    Title IV, Division B of the HITECH Act establishes incentive 
payments under the Medicare and Medicaid programs for eligible 
professionals and eligible hospitals that meaningfully use Certified 
EHR Technology. The Centers for Medicare & Medicaid Services (CMS) is 
charged with developing the Medicare and Medicaid EHR Incentive 
Programs.
i. Medicare EHR Incentive Program
    Section 4101 of the HITECH Act added new subsections to section 
1848 of the SSA to establish incentive payments for the meaningful use 
of Certified EHR Technology by eligible professionals participating in 
the Medicare Fee-for-Service (FFS) program beginning in calendar year 
(CY) 2011, and beginning in CY 2015, downward payment adjustments for 
covered professional services provided by eligible professionals who 
are not meaningful users of Certified EHR Technology. Eligible 
professionals for the Medicare EHR incentive program are physicians as 
defined in section 1861(r) of the SSA. A hospital-based eligible 
professional furnishes substantially all of his or her Medicare-covered 
professional services in a hospital inpatient or emergency room 
setting. Hospital-based eligible professionals are not eligible for the 
Medicare incentive payments. Section 4101(c) of the HITECH Act added a 
new subsection to section 1853 of the SSA that provides incentive 
payments to Medicare Advantage (MA) organizations for their affiliated 
eligible professionals who meaningfully use Certified EHR Technology 
beginning in CY 2011 and beginning in CY 2015, downward payment 
adjustments to MA organizations to account for certain affiliated 
eligible professionals who are not meaningful users of Certified EHR 
Technology.
    Section 4102 of the HITECH Act added new subsections to section 
1886 of the SSA that establish incentive payments for the meaningful 
use of Certified EHR Technology by subsection (d) hospitals (defined 
under section 1886(d)(1)(B) of the SSA) that participate in the 
Medicare FFS program

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beginning in Federal fiscal year (FY) 2011 and beginning in FY 2015, 
downward payment adjustments to the market basket updates for inpatient 
hospital services provided by such hospitals that are not meaningful 
users of Certified EHR Technology. Section 4102(b) of the HITECH Act 
amends section 1814 of the SSA to provide critical access hospitals 
that meaningfully use Certified EHR Technology with an incentive 
payment based on the hospitals' reasonable costs beginning in FY 2011 
and downward payment adjustments for inpatient hospital services 
provided by such hospitals that are not meaningful users of Certified 
EHR Technology for cost reporting periods beginning in FY 2015. Section 
4102(c) of the HITECH Act adds a new subsection to section 1853 of the 
SSA to provide incentive payments to MA organizations for certain 
affiliated eligible hospitals that meaningfully use Certified EHR 
Technology and beginning in FY 2015, downward payment adjustments to MA 
organizations for those affiliated hospitals that are not meaningful 
users of Certified EHR Technology.
ii. Medicaid EHR Incentive Program
    Section 4201 of the HITECH Act amends section 1903 of the SSA to 
provide 100 percent Federal financial participation (FFP) for States' 
expenditures for incentive payments to eligible health care providers 
participating in the Medicaid program to adopt, implement, or upgrade 
and meaningfully use Certified EHR Technology and 90 percent FFP for 
States' reasonable administrative expenses related to the 
administration of the incentive payments. For the Medicaid EHR 
incentive program, eligible professionals are physicians (primarily 
doctors of medicine and doctors of osteopathy), dentists, nurse 
practitioners, certified nurse midwives, and physician assistants 
practicing in a Federally Qualified Health Center led by a physician 
assistant or Rural Health Clinic that is so led. Eligible hospitals 
that can participate in the Medicaid EHR incentive program are acute 
care hospitals (including cancer and critical access hospitals) and 
children's hospitals.
c. HIT Certification Programs
    Section 3001(c)(5) of the PHSA provides the National Coordinator 
with the authority to establish a certification program or programs for 
the voluntary certification of HIT. Specifically, section 3001(c)(5)(A) 
specifies that the ``National Coordinator, in consultation with the 
Director of the National Institute of Standards and Technology, shall 
keep or recognize a program or programs for the voluntary certification 
of health information technology as being in compliance with applicable 
certification criteria adopted under this subtitle'' (i.e., 
certification criteria adopted by the Secretary under section 3004 of 
the PHSA). The certification program(s) must also ``include, as 
appropriate, testing of the technology in accordance with section 
13201(b) of the [HITECH] Act.''
    Section 13201(b) of the HITECH Act requires that with respect to 
the development of standards and implementation specifications, the 
Director of the National Institute of Standards and Technology (NIST), 
in coordination with the HIT Standards Committee, ``shall support the 
establishment of a conformance testing infrastructure, including the 
development of technical test beds.'' The United States Congress also 
indicated that ``[t]he development of this conformance testing 
infrastructure may include a program to accredit independent, non-
Federal laboratories to perform testing.''
2. Regulatory History and Related Guidance
a. Initial Set of Standards, Implementation Specifications, and 
Certification Criteria Interim and Final Rules
    In accordance with section 3004(b)(1) of the PHSA, the Secretary 
issued an interim final rule with request for comments entitled 
``Health Information Technology: Initial Set of Standards, 
Implementation Specifications, and Certification Criteria for 
Electronic Health Record Technology'' (75 FR 2014, Jan. 13, 2010) (the 
``HIT Standards and Certification Criteria interim final rule''), which 
adopted an initial set of standards, implementation specifications, and 
certification criteria. After consideration of the public comments 
received on the interim final rule, a final rule was issued to complete 
the adoption of the initial set of standards, implementation 
specifications, and certification criteria and realign them with the 
final objectives and measures established for meaningful use Stage 1. 
Health Information Technology: Initial Set of Standards, Implementation 
Specifications, and Certification Criteria for Electronic Health Record 
Technology; Final Rule, 75 FR 44590 (July 28, 2010) (the ``HIT 
Standards and Certification Criteria final rule''). On October 13, 
2010, an interim final rule was issued to remove certain implementation 
specifications related to public health surveillance that had been 
previously adopted in the HIT Standards and Certification Criteria 
final rule (75 FR 62686).
    The standards, implementation specifications, and certification 
criteria adopted by the Secretary establish the capabilities that 
Certified EHR Technology must include in order to, at a minimum, 
support the achievement of meaningful use Stage 1 by eligible 
professionals and eligible hospitals under the Medicare and Medicaid 
EHR Incentive Programs final rule (see 75 FR 44314 for more information 
about meaningful use and the Stage 1 requirements).
b. Medicare and Medicaid EHR Incentive Programs Proposed and Final 
Rules
    On January 13, 2010, CMS published in the Federal Register (75 FR 
1844) the Medicare and Medicaid EHR Incentive Programs proposed rule. 
The rule proposed a definition for Stage 1 meaningful use of Certified 
EHR Technology and regulations associated with the incentive payments 
made available under Division B, Title IV of the HITECH Act.
    Subsequently, CMS published a final rule for the Medicare and 
Medicaid EHR Incentive Programs in the Federal Register (75 FR 44314) 
on July 28, 2010 (the ``Medicare and Medicaid EHR Incentive Programs 
final rule''), simultaneously with the publication of the HIT Standards 
and Certification Criteria final rule. The final rule published by CMS 
established the objectives and associated measures that eligible 
professionals and eligible hospitals must satisfy in order to 
demonstrate ``meaningful use'' during Stage 1.
c. HIT Certification Programs Proposed Rule and the Temporary and 
Permanent Certification Programs Final Rules
    Section 3001(c)(5) of the PHSA specifies that the National 
Coordinator ``shall keep or recognize a program or programs for the 
voluntary certification of health information technology as being in 
compliance with applicable certification criteria adopted [by the 
Secretary] under this subtitle.'' Based on this authority, we proposed 
both a temporary and permanent certification program for HIT in a 
notice of proposed rulemaking entitled ``Proposed Establishment of 
Certification Programs for Health Information Technology'' (75 FR 
11328, Mar. 10, 2010) (the ``Proposed Rule''). In the Proposed Rule, we 
proposed to use the certification programs for the purposes of testing 
and

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certifying HIT. We also specified the processes the National 
Coordinator would follow to authorize organizations to perform the 
certification of HIT. We stated in the Proposed Rule that we expected 
to issue separate final rules for each of the certification programs. 
Consistent with our proposal, we issued a final rule to establish a 
temporary certification program, which was published in the Federal 
Register (75 FR 36158) on June 24, 2010 (the ``Temporary Certification 
Program final rule''). To conclude our proposed approach, we are 
issuing this final rule to establish a permanent certification program 
whereby the National Coordinator will authorize organizations to 
certify Complete EHRs, EHR Modules, and/or other types of HIT. As 
provided in the Temporary Certification Program final rule, the 
temporary certification program will sunset on December 31, 2011, or on 
a subsequent date if the permanent certification program is not fully 
constituted at that time.
d. Recognized Certification Bodies as Related to the Physician Self-
Referral Prohibition and Anti-Kickback EHR Exception and Safe Harbor 
Final Rules
    In August 2006, the Department of Health and Human Services (HHS) 
published two final rules in which CMS and the Office of Inspector 
General (OIG) promulgated an exception to the physician self-referral 
prohibition and a safe harbor under the anti-kickback statute, 
respectively, for certain arrangements involving the donation of 
interoperable EHR software to physicians and other health care 
practitioners or entities (71 FR 45140 and 71 FR 45110, respectively). 
The exception and safe harbor provide that EHR software will be 
``deemed to be interoperable if a certifying body recognized by the 
Secretary has certified the software no more than 12 months prior to 
the date it is provided to the [physician/recipient].'' ONC published 
separately a Certification Guidance Document (CGD) (71 FR 44296) to 
explain the factors ONC would use to determine whether to recommend to 
the Secretary an organization for ``recognized certification body'' 
status. The CGD served as a guide for ONC to evaluate applications for 
``recognized certification body'' status and provided the information 
an organization would need to apply for and obtain such status. Under 
the process specified in the CGD, the Certification Commission for 
Health Information Technology (CCHIT) was the only organization that 
both applied for and had been granted ``recognized certification body'' 
status.
    In section VI of the CGD, ONC notified the public, including 
potential applicants, that the recognition process explained in the CGD 
would be formalized through notice and comment rulemaking and that when 
a final rule has been promulgated to govern the process by which a 
``recognized certification body'' is determined, certification bodies 
recognized under the CGD would be required to complete new applications 
and successfully demonstrate compliance with all requirements of the 
final rule.
    In the Proposed Rule, we began the formal notice and comment 
rulemaking described in the CGD. We stated that the processes we 
proposed for the temporary certification program and permanent 
certification program, once finalized, would supersede the CGD, and the 
authorization process would constitute the new established method for 
``recognizing'' certification bodies, as referenced in the physician 
self-referral prohibition and anti-kickback EHR exception and safe 
harbor final rules. As a result of our proposal, certifications issued 
by a certification body ``authorized'' by the National Coordinator 
would constitute certification by ``a certifying body recognized by the 
Secretary'' in the context of the physician self-referral EHR exception 
and anti-kickback EHR safe harbor. After consideration of the public 
comments we received on this proposal, we determined that the ONC-ATCB 
and ONC-ACB ``authorization'' processes would constitute the 
Secretary's ``recognition'' of a certification body and finalized our 
proposal for both the temporary certification program and permanent 
certification program in the Temporary Certification Program final rule 
(75 FR 36186). Any questions regarding compliance with the exception or 
safe harbor should be directed to CMS and OIG, respectively.

II. Overview of the Permanent Certification Program

    The permanent certification program provides a process by which an 
organization or organizations may become an ONC-Authorized 
Certification Body (ONC-ACB) authorized by the National Coordinator to 
perform the certification of Complete EHRs and/or EHR Modules. ONC-ACBs 
may also be authorized under the permanent certification program to 
perform the certification of other types of HIT in the event that 
applicable certification criteria are adopted by the Secretary. We 
note, however, that the certification of Complete EHRs, EHR Modules, or 
potentially other types of HIT under the permanent certification 
program would not constitute a replacement or substitution for other 
Federal requirements that may be applicable.
    Under the permanent certification program, the National Coordinator 
will accept applications for ONC-ACB status after the effective date of 
this final rule and at any time during the existence of the permanent 
certification program. In order to become an ONC-ACB, an organization 
or organizations must submit an application to the National Coordinator 
to demonstrate its competency and ability to certify Complete EHRs, EHR 
Modules, and/or potentially other types of HIT by documenting its 
accreditation by the ONC-Approved Accreditor (ONC-AA) and by meeting 
other specified application requirements. These organizations will be 
required to remain in good standing by adhering to the Principles of 
Proper Conduct for ONC-ACBs. ONC-ACBs will also be required to follow 
the conditions and requirements applicable to the certification of 
Complete EHRs, EHR Modules, and/or potentially other types of HIT as 
specified in this final rule. The permanent certification program will 
eventually replace the temporary certification program that was 
established previously by a final rule (75 FR 36158). Testing and 
certification under the permanent certification program is expected to 
begin on January 1, 2012, or upon a subsequent date when the National 
Coordinator determines that the permanent certification program is 
fully constituted. The permanent certification program has no 
anticipated sunset date. ONC-ACBs are required to renew their status 
every three years under the permanent certification program.

III. Provisions of the Permanent Certification Program; Analysis of and 
Response to Public Comments on the Proposed Rule

A. Overview

    This section discusses and responds to the comments that were 
timely received on the proposed provisions of the permanent 
certification program that were set forth in the Proposed Rule. As 
explained in the Proposed Rule, we chose to propose both the temporary 
certification program and the permanent certification program in the 
same notice of proposed rulemaking in order to offer the public a 
broader context for each of the programs and an opportunity to make 
more informed comments on our proposals. We noted that we expected to 
receive public comments that were

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applicable to both of the proposed certification programs due to the 
fact that we had proposed certain elements that were the same or 
similar for both programs. As anticipated, we received comments in 
response to the Proposed Rule that were applicable to both 
certification programs. In the Temporary Certification Program final 
rule, we discussed and responded to all of the comments that were 
applicable to the temporary certification program. Because some of 
those comments are also related to provisions of the permanent 
certification program, we discuss them again in this final rule and 
respond to them in the context of the permanent certification program. 
Many of the common elements that we proposed for both the temporary and 
the permanent certification programs are based on the same or similar 
underlying policy reasons or objectives. As a result, we often reach 
the same or similar conclusions in this final rule as we did in the 
Temporary Certification Program final rule. In responding to comments 
in this final rule, we often make reference to or restate parts of our 
responses to comments that we provided in the Temporary Certification 
Program final rule due to the various similarities that exist between 
the temporary and permanent certification programs.
    We have structured this section of the final rule based on the 
proposed regulatory sections of the permanent certification program and 
discuss each regulatory section sequentially. For each discussion of a 
regulatory provision, we first restate or paraphrase the provision as 
proposed in the Proposed Rule as well as identify any correlated issues 
for which we sought public comment. Second, we summarize the comments 
received. Lastly, we provide our response to the comments and indicate 
whether we are finalizing the provision as proposed in the Proposed 
Rule or modifying the proposed provision in response to public comment, 
to provide clarification, or to correct inadvertent errors. Comments on 
dual-accredited testing and certification bodies, the concept of 
``self-developed,'' validity and expiration of certifications, 
differential or ``gap'' certification, barriers to entry for potential 
ONC-ACBs, an ONC-managed certification program, general comments, and 
comments beyond the scope of this final rule are discussed towards the 
end of the preamble.

B. Scope and Applicability

    In the Proposed Rule, we indicated in Sec.  170.500 that the 
permanent certification program would serve to implement section 
3001(c)(5) of the PHSA, and that subpart E would also set forth the 
rules and procedures related to the permanent certification program for 
HIT administered by the National Coordinator. Under Sec.  170.501, we 
proposed that subpart E would establish the processes that applicants 
for ONC-ACB status must follow to be granted ONC-ACB status by the 
National Coordinator, the processes the National Coordinator would 
follow when assessing applicants and granting ONC-ACB status, and the 
requirements of ONC-ACBs for certifying Complete EHRs and/or EHR 
Modules in accordance with the applicable certification criteria 
adopted by the Secretary in subpart C of part 170. We also proposed 
that subpart E would establish the processes that accreditation 
organizations would follow to request approval from the National 
Coordinator, the processes the National Coordinator would follow to 
approve an accreditation organization under the permanent certification 
program, and the ongoing responsibilities of an ONC-AA.
    Comments. We received comments that expressed general support for 
the permanent certification program. We also received a few comments 
regarding the extension of the scope of the permanent certification 
program to other types of HIT. One commenter asserted that there was a 
need for the permanent certification program to focus on the 
implementation of the nationwide health information network.
    Response. We appreciate the comments expressing support for the 
permanent certification program. We intend to address the governance 
mechanisms for the nationwide health information network through a 
separate rulemaking. We will more specifically address the comments 
related to other types of HIT when we discuss proposed Sec.  170.553 
later in this preamble, but we note here that we are revising Sec.  
170.501 to acknowledge the possibility for ONC-ACBs to certify ``other 
types of HIT'' under the permanent certification program. We are also 
revising Sec.  170.501 to clearly state that this subpart includes 
requirements that ONC-ACBs must follow to maintain their status as ONC-
ACBs under the permanent certification program. These references were 
inadvertently left out of Sec.  170.501 in the Proposed Rule although 
they were included elsewhere in the preamble discussion and regulation 
text.

C. Definitions

    In the Proposed Rule, we proposed to define four terms related to 
the permanent certification program.
1. Day or Days
    We proposed to add the definition of ``day or days'' to Sec.  
170.102. We proposed to define ``day or days'' to mean a calendar day 
or calendar days. We added this definition to Sec.  170.102 in the 
Temporary Certification Program final rule. Further, we did not receive 
any comments on this definition related to the permanent certification 
program. Therefore, references to ``day'' or ``days'' in provisions of 
subpart E have the meaning provided to them in Sec.  170.102.
2. Applicant
    We proposed in Sec.  170.502 to define ``applicant'' to mean a 
single organization or a consortium of organizations that seek to 
become an ONC-ACB by requesting and subsequently submitting an 
application for ONC-ACB status to the National Coordinator. We did not 
receive any comments on this proposed definition. We are, however, 
revising the definition of ``applicant'' by removing the condition that 
an ``applicant'' must ``request'' an application. We clearly indicated 
in the Proposed Rule preamble that, unlike under the temporary 
certification program, ``applicants'' for ONC-ACB status would no 
longer need to request an application.
3. ONC-ACB
    We proposed in Sec.  170.502 to define an ``ONC-Authorized 
Certification Body'' or ``ONC-ACB'' to mean an organization or a 
consortium of organizations that has applied to and been authorized by 
the National Coordinator pursuant to subpart E to perform the 
certification of, at minimum, Complete EHRs and/or EHR Modules using 
the applicable certification criteria adopted by the Secretary.
    Comments. A commenter noted that the proposed definition would not 
preclude an ONC-ACB from certifying other types of HIT, but would 
require an ONC-ACB to be able to certify Complete EHRs and/or EHR 
Modules. The commenter contended that this requirement will prevent 
organizations that may want to certify only other types of HIT (and not 
Complete EHRs or EHR Modules) from becoming ONC-ACBs.
    Response. We did not intend to preclude an organization from 
seeking authorization to certify only other types of HIT besides 
Complete EHRs and EHR Modules, when and if the option becomes 
available. To the contrary, as noted in proposed Sec.  170.510, we 
indicated that an applicant could seek authorization to certify 
Complete EHRs, EHR Modules, other types of HIT, or any

[[Page 1267]]

combination of the three. However, as we specified in the Proposed Rule 
preamble and in proposed Sec.  170.510, the Secretary must first adopt 
applicable certification criteria under subpart C of part 170 before 
authorization to certify other types of HIT could be granted to ONC-
ACBs.
    In response to the comment and to be consistent with our intent as 
expressed in Sec.  170.510, we are removing ``at a minimum'' from the 
definition of ONC-ACB. This will allow an organization or consortium of 
organizations to become an ONC-ACB that is authorized to certify only 
other types of HIT besides Complete EHRs and/or EHR Modules. We are 
also revising the definition by replacing ``using the applicable 
certification criteria adopted by the Secretary'' with ``under the 
permanent certification program.'' We believe this revision more 
clearly reflects the focus of an ONC-ACB and is more consistent with 
the definition of an ONC-ATCB that we finalized in the Temporary 
Certification Program final rule. We note that ONC-ACBs that are 
authorized to certify Complete EHRs and/or EHR Modules will be required 
to perform certifications using the applicable certification criteria 
adopted by the Secretary based on the provisions of Sec. Sec.  170.545 
and 170.550.
4. ONC-AA
    We proposed in Sec.  170.502 to define the term ``ONC-Approved 
Accreditor'' or ``ONC-AA'' to mean an accreditation organization that 
the National Coordinator has approved to accredit certification bodies 
under the permanent certification program.
    We did not receive any comments on this proposed definition. 
Therefore, we are finalizing this definition without modification.

D. ONC-AA Status, On-going Responsibilities and Reconsideration of 
Request for ONC-AA Status

    In the Proposed Rule, we proposed processes for requesting ONC-AA 
status, the process for reviewing and approving an ONC-AA, the ongoing 
responsibilities of an ONC-AA, and the process for an accreditation 
organization to request reconsideration of its denied request for ONC-
AA status.
1. ONC-AA Status
    We proposed in Sec.  170.503 that the National Coordinator would 
approve only one ONC-AA at a time. We proposed that in order for an 
accreditation organization to become an ONC-AA, it would need to submit 
a request in writing to the National Coordinator along with certain 
information to demonstrate its ability to serve as an ONC-AA. This 
information included: A detailed description of how the accreditation 
organization conforms to ISO/IEC17011:2004 (ISO 17011) and its 
experience evaluating the conformance of certification bodies to ISO/
IEC Guide 65:1996 (Guide 65); a detailed description of the 
accreditation organization's accreditation requirements and how the 
requirements complement the Principles of Proper Conduct for ONC-ACBs; 
detailed information about the accreditation organization's procedures 
that would be used to monitor ONC-ACBs; detailed information, including 
education and experience, about the key personnel who would review 
organizations for accreditation; and the accreditation organization's 
procedures for responding to, and investigating, complaints against 
ONC-ACBs.
    We proposed that the National Coordinator would be permitted up to 
30 days to review a request for ONC-AA status from an accreditation 
organization upon receipt and issue a determination on whether the 
organization is approved. We proposed that the National Coordinator's 
determination would be based on the information and the completeness of 
the descriptions provided, as well as each accreditation organization's 
overall accreditation experience. We proposed that the National 
Coordinator would review requests by accreditation organizations for 
ONC-AA status in the order they were received and would approve the 
first qualified accreditation organization based on the information 
required to be submitted with a request for ONC-AA status. We proposed 
that an ONC-AA's status would expire not later than 3 years from the 
date its status was granted by the National Coordinator. We further 
proposed that beginning 120 days prior to the expiration of the then-
current ONC-AA's status, the National Coordinator would again accept 
requests for ONC-AA status.
    We specifically requested comment on whether it would be in the 
best interest of the ONC-ACB applicants and Complete EHR and EHR Module 
developers to allow for more than one ONC-AA at a time and whether we 
should extend the duration of an ONC-AA's term to 5 years, shorten it 
to 2 years, or identify a different period of time.
    Comments. Commenters expressed support for an independent 
accreditation body, which they stated would provide an open and 
transparent process. One commenter, however, asked for clarification as 
to why we proposed to have an accreditor independent of ONC. The 
commenter stated that the proposal seemed to introduce unnecessary 
overhead. A commenter also requested clarification of the requirement 
for an ONC-AA to conform to ISO 17011. Another commenter recommended 
that we require an ONC-AA to be recognized under the NIST National 
Voluntary Conformity Assessment Systems Evaluation, or ``NVCASE'' 
program. The commenter further recommended that the ONC-AA should 
demonstrate its ISO 17011 compliance for the ISO Guide 65 scope by 
being a signatory to the International Accreditation Forum's Mutual/
Multilateral Recognition Agreement (MRA) for product certification, 
which is verified by regular peer assessments. The commenter stated 
that such a requirement would mirror a benchmark set elsewhere for 
similar Federal agency program requirements for an accreditation body 
(i.e., the U.S. EPA ``WaterSense'' program requirements).
    Many commenters recommended that there be only one ONC-AA to ensure 
consistency, while only two commenters expressed openness to having 
more than one ONC-AA at a time. One of the commenters favoring more 
than one ONC-AA opined that the approval of more than one accreditor 
would ensure that all potential ONC-ACBs could be timely accredited and 
that the unique needs of potential ONC-ACBs would be adequately 
addressed, such as in the case of organizations that seek to certify 
other types of HIT besides Complete EHRs and EHR Modules. The other 
commenter suggested that we consider approving more than one ONC-AA if 
we anticipate a high volume of applicants for ONC-ACB status. One 
commenter stated that, given the importance of the ONC-AA in ensuring 
that the accredited certification bodies operate in a fair and 
effective manner, the ONC-AA should be chosen through an open 
competition that would allow for the comparison of the strengths and 
weaknesses of all interested accreditation organizations.
    Commenters expressed support for either 3-year or 5-year terms for 
an ONC-AA. Some commenters suggested 5 years would provide more 
reliability and consistency. One commenter suggested an interim review 
of the ONC-AA after 3 years and granting an ``extension'' to 5 years 
based on the results of the review. One commenter suggested that an 
ONC-AA should not be allowed to ``renew'' its status at the end of the 
proposed 3-year term. The commenter contended that this would prevent 
an ONC-AA from overly

[[Page 1268]]

influencing how certification bodies are accredited. A commenter 
recommended that we begin accepting and reviewing requests for ONC-AA 
status sooner than 120 days prior to the expiration of the then-current 
ONC-AA's status and suggested 180 days as a possible alternative. The 
commenter reasoned that more time may be necessary to review and 
approve an ONC-AA. A couple of commenters requested clarification 
regarding how we would address concerns with an ONC-AA's operations and 
how we would remove or replace an ineffective ONC-AA.
    Response. We do not believe that the use of an accreditor is 
unnecessary overhead. As stated in the Proposed Rule, we believe that 
accreditation (and the use of an accreditor) is the optimal and most 
practical approach for the long term because specialized accreditors in 
the private sector are better equipped to react effectively and 
efficiently to changes in the HIT market and to rigorously oversee the 
certification bodies they accredit. Further, the impartiality, 
knowledge, and experience of an accreditor will instill additional 
confidence in HIT developers, eligible professionals and eligible 
hospitals, and the general public regarding the ONC-ACB selection 
process. We believe that conformance to ISO 17011 is an appropriate 
measure to assess an accreditation organization's ability to perform 
accreditation under the permanent certification program, among the 
other submission requirements specified in Sec.  170.503. ISO 17011 was 
developed by the International Organization for Standardization (ISO) 
and specifies the general requirements for accreditation bodies that 
accredit conformity assessment bodies. As noted in the Proposed Rule, 
an ONC-AA and the ONC-ACBs would be analogous to an accreditation body 
and the conformity assessment bodies, respectively, as referred to in 
ISO 17011. The introductory section of ISO 17011 explains that a system 
to accredit conformity assessment bodies is designed to provide 
confidence to the purchaser and the regulator through impartial 
verification that conformity assessment bodies are competent to perform 
their tasks. ISO 17011 and Guide 65 are standards that have been 
developed by a voluntary consensus standards body, as required by the 
National Technology Transfer and Advancement Act of 1995 and the Office 
of Management and Budget (OMB) Circular A-119, and we are aware of no 
alternative voluntary consensus standards that would serve the purpose 
for which these standards are intended to serve.
    We appreciate the recommendations by the commenter, but we do not 
believe that it is necessary or appropriate to require an accreditation 
organization to be recognized under the NVCASE program or as a 
signatory to the International Accreditation Forum's MRA. It is our 
understanding that some of the requirements for recognition under the 
NVCASE program are similar to the requirements we have proposed for an 
accreditation organization to be approved as an ONC-AA. For example, 
the NVCASE Program Handbook states that the generic requirements for 
recognition as an accreditor are based on the ISO/IEC 17011 standard, 
and recognized accreditors of certification bodies must accredit those 
bodies to ISO/IEC Guide 65.\1\ Therefore, we do not believe that a 
sufficient additional benefit would result from requiring accreditation 
organizations to be recognized under the NVCASE program. Adding such a 
requirement at this point may not provide sufficient notice and time 
for accreditation organizations that are not currently recognized by 
the NVCASE program to obtain NVCASE recognition in time to be eligible 
for approval as the ONC-AA at the start of the permanent certification 
program. Although we will not require an accreditation organization to 
be a signatory to the International Accreditation Forum's MRA, this 
information could be provided as part of an accreditation 
organization's detailed description of its accreditation experience to 
be included in its submitted request for ONC-AA status.
---------------------------------------------------------------------------

    \1\ National Institute of Standards and Technology, U.S. Dep't 
of Commerce, NVCASE Program Handbook, NISTIR 6440 2004 ED (Dec. 
2004), available at http://gsi.nist.gov/global/index.cfm/L1-4/L2-38.
---------------------------------------------------------------------------

    We agree with the commenters that, as proposed, granting ONC-AA 
status to only one accreditation body at a time is the best way to 
ensure consistency among ONC-ACBs. In addition, we believe that one 
ONC-AA will be able to address and support the needs of the market 
based on our projection of approximately 6 ONC-ACBs operating under the 
permanent certification program. We also agree with the commenter that 
suggested the ONC-AA should be chosen based on a competitive process 
that would allow us to evaluate all interested accreditation 
organizations in comparison to each other and select the organization 
that is best qualified to serve as the ONC-AA. Under the process we 
proposed, the National Coordinator would review requests for ONC-AA 
status in the order they are received and select as the ONC-AA the 
first accreditation organization that is deemed to be qualified based 
on the factors specified in Sec.  170.503(b). We recognize the 
limitations of this approach in that it would prevent the National 
Coordinator from considering all of the requests for ONC-AA status that 
are submitted and selecting the accreditation organization that is 
found to be the best qualified in comparison to the entire pool of 
organizations that submitted requests for ONC-AA status. We believe 
that the permanent certification program would benefit from a more 
competitive approach to selecting the ONC-AA. A competitive process 
will ensure the best qualified organization that submits a request is 
chosen as the ONC-AA, which will improve the overall quality of the 
program and instill confidence in the general public as well as 
industry stakeholders.
    We are revising Sec.  170.503 to eliminate the provision for the 
National Coordinator to review requests for ONC-AA status in order of 
receipt and approve the first qualified accreditation organization. 
Instead, under this revised Sec.  170.503, the National Coordinator 
will review all timely requests for ONC-AA status in one batch and 
choose the best qualified accreditation organization to serve as the 
ONC-AA. We are revising Sec.  170.503(b) to provide a 30-day period 
during which all interested accreditation organizations may submit 
requests for ONC-AA status. We will publish a notice in the Federal 
Register to announce this submission period. We are revising Sec.  
170.503(c) to permit the National Coordinator up to 60 days to review 
all timely submissions and determine which accreditation organization 
is best qualified to serve as the ONC-AA based on the information 
provided in the submissions and each organization's overall 
accreditation experience. We originally proposed to permit the National 
Coordinator up to 30 days to review a request for ONC-AA status and 
make a decision. Based on the changes to the ONC-AA approval process, 
the National Coordinator will likely need more time to review and 
compare all of the requests for ONC-AA status in one batch and 
determine which accreditation organization is best qualified to be the 
ONC-AA out of a potential pool of multiple organizations. The National 
Coordinator will select the best qualified accreditation organization 
as the ONC-AA on a preliminary basis and subject to the resolution of 
the reconsideration process in Sec.  170.504. The accreditation 
organization that is selected on a preliminary basis is not

[[Page 1269]]

permitted to represent itself as the ONC-AA or perform any 
accreditation(s) under the permanent certification program, unless and 
until it is notified by the National Coordinator that it has been 
approved as the ONC-AA on a final basis. All other accreditation 
organizations will be notified that their requests for ONC-AA status 
have been denied.
    Any accreditation organization that submits a timely request for 
ONC-AA status and is denied may request reconsideration of that 
decision pursuant to Sec.  170.504. In order to request reconsideration 
under revised Sec.  170.504(b), an accreditation organization must 
submit to the National Coordinator, within 15 days of its receipt of a 
denial notice, a written statement with supporting documentation 
contesting the decision to deny its request for ONC-AA status. The 
submission must demonstrate that clear, factual errors were made in the 
review of its request for ONC-AA status and that it would have been 
selected as the ONC-AA pursuant to Sec.  170.503(c) if those errors had 
been corrected. Requests for reconsideration that are not received 
within the specified timeframe may be denied. We are revising Sec.  
170.504(c) such that the National Coordinator will have up to 30 days 
to review all timely submissions and determine whether an accreditation 
organization has met the standard specified in Sec.  170.504(b) (i.e., 
its submission has demonstrated that clear, factual errors were made in 
the review of its request for ONC-AA status and that it would have been 
selected as the ONC-AA pursuant to Sec.  170.503(c) if those errors had 
been corrected). In determining whether an accreditation organization 
would have been selected as the ONC-AA, the National Coordinator will 
evaluate those accreditation organizations that demonstrate clear, 
factual errors, in comparison to each other as well as to the 
accreditation organization that was initially selected as the ONC-AA on 
a preliminary basis.
    We are adding a new paragraph (d) to Sec.  170.503 and revising 
Sec.  170.504(d) such that if the National Coordinator determines that 
an accreditation organization has demonstrated that clear, factual 
errors were made in the review of its request for ONC-AA status and 
that it would have been selected as the ONC-AA pursuant to Sec.  
170.503(c) if those errors had been corrected, then that organization 
will be approved as the ONC-AA on a final basis. All other 
accreditation organizations will be notified that their requests for 
reconsideration have been denied. Conversely, if the National 
Coordinator determines that no accreditation organization has met the 
standard specified in Sec.  170.504(b), then the organization that was 
initially selected as the ONC-AA on a preliminary basis will be 
approved as the ONC-AA on a final basis. An accreditation organization 
has not been granted ``ONC-AA status'' unless and until it is notified 
by the National Coordinator that it has been approved as the ONC-AA on 
a final basis, as stated in revised paragraph (f) of Sec.  170.503.
    We believe that it is appropriate to provide a 3-year term for an 
ONC-AA. A 5-year term may provide more consistency and reliability, but 
we believe a 3-year term provides an appropriate interval to fully 
assess an ONC-AA's performance under the permanent certification 
program and provide an opportunity for other interested organizations 
to seek ONC-AA status. We believe all interested accreditation 
organizations should be given the opportunity to request ONC-AA status 
when the National Coordinator is seeking to approve an ONC-AA. An 
interested accreditation organization should not be barred from 
``reapplying'' simply because it previously served as an ONC-AA. Such a 
preclusion could prevent the National Coordinator from approving the 
best qualified accreditation organization or the only interested 
organization.
    We agree with the commenter that we should begin to accept requests 
for ONC-AA status sooner than 120 days prior to the expiration of the 
then-current ONC-AA's status as we originally proposed. Similar to the 
commenter's recommendation, the National Coordinator will begin to 
accept requests for ONC-AA status at least 180 days prior to the 
expiration of the then-current ONC-AA's status. We believe this will 
give the market more time to transition to a new ONC-AA if we were to 
approve a different accreditation organization as the ONC-AA. We note, 
however, that if we were to approve a different accreditation 
organization as the ONC-AA, its status would not become effective until 
after the end of the then-current ONC-AA's term. As with the approval 
of the first ONC-AA and in accordance with the revised Sec.  
170.503(b), we will notify the public of the 30-day period for 
requesting ONC-AA status by publishing a notice in the Federal 
Register. Consistent with this discussion, we are revising Sec.  
170.503(f)(3) to specify that the National Coordinator will accept 
requests for ONC-AA status, in accordance with paragraph (b), at least 
180 days before the then-current ONC-AA's status is set to expire.
    As pointed out by the commenters, we did not propose a formal 
process for the National Coordinator to remove or take other corrective 
action against an ONC-AA that is performing poorly. We recognize that 
an ONC-AA, like an ONC-ACB, has significant responsibilities under the 
permanent certification program that are inextricably linked to the 
success of the permanent certification program. We agree with the 
commenters that a specified process for the National Coordinator to 
address poor performance or inappropriate conduct by an ONC-AA would be 
beneficial for the permanent certification program and would ensure 
that an ONC-AA is held accountable for its actions. Accordingly, we 
intend to issue a notice of proposed rulemaking (NPRM) that will 
address improper conduct by an ONC-AA, the potential consequences for 
engaging in such conduct, and a process by which the National 
Coordinator may take corrective action against an ONC-AA. We expect to 
issue this NPRM in the near future and do not believe it will 
unnecessarily delay the implementation of the permanent certification 
program.
2. On-Going Responsibilities
    We proposed in Sec.  170.503(e) that an ONC-AA would be required 
to, at minimum: Maintain conformance with ISO 17011; in accrediting 
certification bodies, verify conformance to, at a minimum, Guide 65; 
verify that ONC-ACBs are performing surveillance in accordance with 
their respective annual plans; and review ONC-ACB surveillance results 
to determine if the results indicate any substantive non-conformance 
with the terms set by the ONC-AA when it granted the ONC-ACB 
accreditation. We specifically requested public comment on these 
proposed responsibilities and whether there are other responsibilities 
that we should require an ONC-AA to fulfill.
    Comments. A couple of commenters expressed agreement with the 
outlined responsibilities. One commenter suggested that the ONC-AA 
should provide annual reports of the results of their responsibilities. 
The commenter also recommended that the ONC-AA should review and/or 
audit all ONC-ACB processes, such as bylaws and standard operating 
procedures, no less than annually.
    Response. We appreciate the expression of confidence in the ongoing 
responsibilities we have proposed for an ONC-AA. We also appreciate the 
commenter's recommendations for annual reports on the ONC-AA's

[[Page 1270]]

responsibilities and annual reviews and/or audits by the ONC-AA of all 
ONC-ACBs' processes. We believe, however, that annual reports from the 
ONC-AA are unnecessary. As stated above, the approval of an ONC-AA 
every three years will serve as a sufficient periodic review of the 
ONC-AA. There will also be opportunities to assess an ONC-AA's 
performance of its responsibilities at other junctures during the 
permanent certification program. The Principles of Proper Conduct for 
ONC-ACBs require ONC-ACBs to submit annual surveillance plans and to 
annually report surveillance results to the National Coordinator. Our 
review of an ONC-ACB's surveillance results should give an indication 
of whether the ONC-AA is performing its responsibilities to review ONC-
ACB surveillance results and verify that ONC-ACBs are performing 
surveillance in accordance with their surveillance plans. We also 
expect that our review and analysis of surveillance plans and results 
will not only include feedback from the ONC-ACBs but also from the ONC-
AA. The ONC-AA feedback will provide us with additional information on 
the ONC-AA's performance of its monitoring and review responsibilities 
related to ONC-ACB surveillance activities.
    ISO 17011 specifies that an accreditation body (i.e., an ONC-AA) 
shall require a conformance assessment body (i.e., an ONC-ACB) to 
commit to fulfill continually the requirements for accreditation set by 
the accreditation body, cooperate as is necessary to enable the 
accreditation body to verify fulfillment of requirements for 
accreditation, and report changes that may affect its accreditation to 
the accreditor. ISO 17011 also contains provisions that require an ONC-
AA to review an ONC-ACB periodically, but no less than every two years, 
and to do so in a manner prescribed under ISO 17011. Moreover, as one 
of its ongoing responsibilities, the ONC-AA will be required to verify 
that ONC-ACBs continue to conform to the provisions of Guide 65 at a 
minimum as a condition of continued accreditation. We believe these 
provisions will enable the ONC-AA to sufficiently oversee (i.e., review 
and/or audit) the ONC-ACBs for the purposes of the permanent 
certification program. For instance, if the ONC-AA finds that an ONC-
ACB is not in compliance with its accreditation requirements, then the 
ONC-ACB may lose its accreditation and subsequently its ONC-ACB status. 
The Principles of Proper Conduct for ONC-ACBs will also provide 
additional assurance that ONC-ACBs are operating in an acceptable 
manner under the permanent certification program.
    We are revising Sec.  170.503(e)(4) to state that the ONC-AA will 
be responsible for reviewing ONC-ACB surveillance results to determine 
if the results indicate any substantive non-conformance by ONC-ACBs 
``with the conditions of their respective accreditations.'' We believe 
this clarification more accurately accounts for the possibility that 
different accreditation organizations may be approved to serve as the 
ONC-AA.
3. Reconsideration of Request for ONC-AA Status
    We proposed in Sec.  170.503(d) that an accreditation organization 
could appeal a decision to deny its request for ONC-AA status in 
accordance with Sec.  170.504, but only if no other accreditation 
organization had been granted ONC-AA status. We proposed in Sec.  
170.504 to use generally the same procedures for reconsideration of an 
accreditation organization's request for ONC-AA status as we did for 
reconsideration of applications for ONC-ACB status with a few 
substantive distinctions. We proposed that an accreditation 
organization could ask the National Coordinator to reconsider a 
decision to deny its request for ONC-AA status only if no other 
accreditation organization had been granted ONC-AA status and it could 
demonstrate that clear, factual errors were made in the review of its 
request for ONC-AA status and that the errors' correction could lead to 
the accreditation organization obtaining ONC-AA status. We proposed 
that an accreditation organization that wished to contest its denial 
would be required to submit, within 15 days of receipt of a denial 
notice, a written statement to the National Coordinator contesting the 
decision to deny its request for ONC-AA status and explaining with 
sufficient documentation what factual error(s) it believes can account 
for the denial. We proposed that if the National Coordinator did not 
receive the accreditation organization's written statement within the 
specified timeframe that its request for reconsideration could be 
rejected. We proposed that the National Coordinator would have up to 15 
days to consider a timely reconsideration request. We further proposed 
that if, after reviewing an applicant's reconsideration request, the 
National Coordinator determined that the applicant did not identify any 
factual errors, that correction of those factual errors would not 
remove all identified deficiencies, or that a qualified ONC-AA had 
already been approved, the National Coordinator could reject the 
applicant's reconsideration request and that this decision would be 
final and not subject to further review.
    We did not receive any comments on these provisions. We are, 
however, revising Sec.  170.503(c) and (d) and Sec.  170.504 consistent 
with the changes we discussed earlier in this section of the preamble.

E. Correspondence

    We proposed in Sec.  170.505 to require applicants for ONC-ACB 
status and ONC-ACBs to correspond and communicate with the National 
Coordinator by e-mail, unless otherwise necessary. We proposed that the 
official date of receipt of any e-mail between the National Coordinator 
and an applicant for ONC-ACB status or an ONC-ACB would be the day the 
e-mail was sent. We further proposed that in circumstances where it was 
necessary for an applicant for ONC-ACB status or an ONC-ACB to 
correspond or communicate with the National Coordinator by regular or 
express mail, the official date of receipt would be the date of the 
delivery confirmation.
    We did not receive any comments on these proposals. We are, 
however, revising Sec.  170.505 to include ``or an ONC-ACB'' in 
paragraph (b) to clarify that either an applicant for ONC-ACB status or 
an ONC-ACB may, when necessary, utilize the specified correspondence 
methods. This reference was inadvertently left out of Sec.  170.505(b) 
in the Proposed Rule. We are also revising this section to apply the 
correspondence requirements to accreditation organizations that submit 
requests for ONC-AA status and the ONC-AA. These organizations are 
similarly situated to applicants for ONC-ACB status and ONC-ACBs with 
respect to corresponding with ONC. In particular, with our revisions 
that establish a specific time period for submitting requests for ONC-
AA status, application of Sec.  170.505 to accreditation organizations 
requesting ONC-AA status will provide a clear understating of when a 
request will be deemed received by the National Coordinator. Overall, 
we believe that applying the correspondence requirements to 
accreditation organizations requesting ONC-AA status and the ONC-AA 
will increase the efficiencies of the permanent certification program 
and lessen the correspondence burden on these organizations.

[[Page 1271]]

F. Certification Options for ONC-ACBs

1. Distinction Between Testing and Certification
    We stated in the Proposed Rule that there is a distinct difference 
between the ``testing'' and ``certification'' of a Complete EHR and/or 
EHR Module. We described ``testing'' as the process used to determine 
the degree to which a Complete EHR or EHR Module can meet specific, 
predefined, measurable, and quantitative requirements. We noted that 
such results would be able to be compared to and evaluated in 
accordance with predefined measures. In contrast, we described 
``certification'' as the assessment (and subsequent assertion) made by 
an organization, once it has analyzed the quantitative results rendered 
from testing along with other qualitative factors, that a Complete EHR 
or EHR Module has met all of the applicable certification criteria 
adopted by the Secretary. We noted that qualitative factors could 
include whether a Complete EHR or EHR Module developer has a quality 
management system in place, or whether the Complete EHR or EHR Module 
developer has agreed to the policies and conditions associated with 
being certified (e.g., proper logo usage). We further stated that the 
act of certification typically promotes confidence in the quality of a 
product (and the Complete EHR or EHR Module developer that produced 
it), offers assurance that the product will perform as described, and 
helps consumers to differentiate which products have met specific 
criteria from others that have not.
    To further clarify, we stated that a fundamental difference between 
testing and certification is that testing is intended to result in 
objective, unanalyzed data. In contrast, certification is expected to 
result in an overall assessment of the test results, consideration of 
their significance, and consideration of other factors to determine 
whether the prerequisites for certification have been achieved. To 
illustrate an important difference between testing and certification, 
we provided the example that we recite below.
    An e-prescribing EHR Module developer that seeks to have its EHR 
Module certified would first submit the EHR Module to be tested. To 
successfully pass the established testing requirements, the e-
prescribing EHR Module would, among other functions, need to transmit 
an electronic prescription using mock patient data according to the 
standards adopted by the Secretary. Provided that the e-prescribing EHR 
Module successfully passed this test it would next be evaluated for 
certification. Certification could require that the EHR Module 
developer agree to a number of provisions, including, for example, 
displaying the EHR Module's version and revision number so potential 
purchasers could discern when the EHR Module was last updated or 
certified. If the EHR Module developer agreed to all of the applicable 
certification requirements and the EHR Module achieved a passing test 
result, the e-prescribing EHR Module would be certified. In these 
situations, both the EHR Module passing the technical requirements 
tests and the EHR Module vendor meeting the other certification 
requirements would be required for the EHR Module to achieve 
certification.
    Comments. Multiple commenters asked for additional clarification 
for the distinction between testing and certification. Commenters were 
concerned that ONC-ACBs would have too much discretion related to 
certification. The commenters asserted that ONC-ACBs should only be 
empowered to assess whether adopted certification criteria have been 
met or whether other applicable policies adopted by the National 
Coordinator through regulation, such as ``labeling'' policies, have 
been complied with. Commenters expressed specific concern with one of 
our examples of potential qualitative factors, which was the need to 
have ``a quality management system in place.'' The commenters suggested 
that a requirement to have a quality management system in place is 
vague and gives too much discretion to an ONC-ACB.
    Response. Our response to these comments is similar to the response 
we provided in the Temporary Certification Program final rule due to 
similarities that exist between the two certification programs. We 
require as a Principle of Proper Conduct that ONC-ACBs shall maintain 
their accreditation, which will, at minimum, require ONC-ACBs to 
operate their certification programs in accordance with Guide 65. As 
noted above, the ONC-AA will be required to verify that ONC-ACBs 
continue to conform to Guide 65 at a minimum as a condition of 
maintaining their accreditation. Guide 65 specifies the requirements 
that an organization must follow to operate a certification program. 
Moreover, because Guide 65 states in section 4.6.1 that a 
``certification body shall specify the conditions for granting, 
maintaining and extending certification,'' we believe that it would be 
inappropriate to dictate every specific aspect related to an ONC-ACB's 
certification program operations. We understand the concerns expressed 
by commenters over our example of a ``quality management system'' as 
another factor that ONC-ACBs may choose to include, in accordance with 
Guide 65, as part of their certification requirements for assessing 
Complete EHRs and/or EHR Modules and have considered how to best 
address such concerns.
    With respect to those commenters who requested that we clarify the 
purview of ONC-ACBs related to certification and expressed concerns 
about the level of discretion afforded to ONC-ACBs, we agree that 
additional clarity is necessary regarding our intent and expectations 
of ONC-ACBs as initially expressed in our discussion of the differences 
between testing and certification in the Proposed Rule. We believe 
commenters were expressing a concern that certification could include 
other factors beyond the certification criteria adopted by the 
Secretary in subpart C of part 170, which could prevent them from 
receiving a certification in a timely manner if they were not aware of 
those factors. We agree with commenters that this is a legitimate 
concern. We did not intend to convey through our examples that we would 
adopt additional requirements for certification in this final rule 
beyond the certification criteria adopted by the Secretary in subpart C 
of part 170 and the other requirements imposed on ONC-ACBs in subpart E 
of part 170.
    We seek to make clear that the primary responsibility of ONC-ACBs 
under the permanent certification program is to certify Complete EHRs 
and EHR Modules, and potentially other types of HIT at some point in 
the future, in accordance with the certification criteria adopted by 
the Secretary. In consideration of the comments and the preceding 
discussion, we are adding new provisions to Sec.  170.545 (paragraph 
(b)) and Sec.  170.550 (paragraph (b)) to make it explicitly clear that 
an ONC-ACB must offer the option for a Complete EHR or EHR Module to be 
certified solely to the applicable certification criteria adopted by 
the Secretary and not to any additional certification criteria. In 
other words, if a developer makes a request for its Complete EHR or EHR 
Module to be certified solely to the applicable certification criteria 
adopted by the Secretary, an ONC-ACB cannot require the Complete EHR or 
EHR Module to be certified to any other certification criteria beyond 
those that have been adopted by the Secretary. In complying with such a 
request, the ONC-ACB would still be expected to issue

[[Page 1272]]

certifications in accordance with the requirements specified by subpart 
E of part 170 (for example, Sec.  170.523(k)). As a matter of its own 
business practices, however, an ONC-ACB may decide to offer multiple 
options for the certification of HIT, some of which could potentially 
impose other requirements for certification or include additional 
certification criteria beyond what has been adopted by the Secretary. 
If an ONC-ACB chooses to offer multiple certification options for HIT, 
we expect it would be done consistent with the requirements of the ONC-
ACB's accreditation. Additionally, in accordance with Guide 65, section 
6, the ONC-ACB would be required to ``give due notice of any changes it 
intends to make in its requirements for certification'' and ``take 
account of views expressed by interested parties before deciding on the 
precise form and effective date of the changes.''
    We note, however, that while we do not preclude an ONC-ACB from 
certifying HIT in accordance with its own requirements that may be 
unrelated to and potentially exceed the certification criteria adopted 
by the Secretary, such activities would not be within the scope of an 
ONC-ACB's authority granted under the permanent certification program 
and should not be considered to be endorsed or approved by the National 
Coordinator or the Secretary. Accordingly, we have added as a component 
of a new principle in the Principles of Proper Conduct for ONC-ACBs 
(discussed in more detail in section O. Validity of Complete EHR and 
EHR Module Certification and Expiration of Certified Status) that any 
certifications that are based solely on the applicable certification 
criteria adopted by the Secretary at subpart C must be separate and 
distinct from any other certification(s) that are based on other 
criteria or requirements. To further clarify, HIT that meets the 
definition of a Complete EHR or EHR Module and is certified to the 
certification criteria adopted by the Secretary as well as to an ONC-
ACB's own additional certification criteria must have its certified 
status as a Complete EHR or EHR Module noted separately and distinctly 
from any other certification the ONC-ACB may issue based on its own 
certification criteria. For example, an ONC-ACB should indicate that 
the HIT has been certified as a ``Complete EHR in accordance with the 
applicable certification criteria adopted by the Secretary of Health 
and Human Services'' and, if applicable, separately indicate that the 
HIT meets ``XYZ certification criteria as developed and/or required by 
[specify certification body].''
2. Types of Certification
    We proposed in Sec.  170.510 that applicants for ONC-ACB status may 
seek authorization from the National Coordinator to perform Complete 
EHR certification, EHR Module certification, and/or certification of 
other types of HIT for which the Secretary has adopted certification 
criteria under subpart C of this part.
    We received multiple comments on the types of certification that 
ONC-ACBs can and should perform. These comments were in direct response 
to our requests for public comments on whether ONC-ACBs should certify 
the integration of EHR Modules and on whether applicants for ONC-ACB 
status should be permitted to apply to certify only Complete EHRs 
designed for an ambulatory setting or only Complete EHRs designed for 
an inpatient setting.
a. Complete EHRs for Ambulatory or Inpatient Settings
    We requested public comment in the Proposed Rule on whether the 
National Coordinator should permit applicants under the permanent 
certification program to seek authorization to certify only Complete 
EHRs designed for an ambulatory setting or, alternatively, only 
Complete EHRs designed for an inpatient setting. Under our proposal, an 
applicant seeking authorization to perform Complete EHR certification 
would be required to certify Complete EHRs designed for both ambulatory 
and inpatient settings.
    Comments. We received comments ranging from support for providing 
the option for applicants to certify Complete EHRs for either 
ambulatory or inpatient settings to support for our proposal to require 
an ONC-ACB to perform certification for both settings. Some commenters 
thought that our proposal could stifle competition and expressed 
concern that there may not be enough entities capable of performing 
Complete EHR certification for both settings. These commenters stated 
that allowing for Complete EHR certification for either an ambulatory 
or inpatient setting could enhance competition and expedite 
certifications. Conversely, a few commenters stated that providing the 
option would multiply the National Coordinator's application workload 
and slow the authorization of ONC-ACBs. One commenter also thought that 
the option may lead to applicants for ONC-ACB status competing for 
limited resources, such as specialized staff for conducting 
certification.
    Some commenters expressed concern that if the National Coordinator 
were to allow applicants to certify Complete EHRs for either ambulatory 
or inpatient settings, there would not be enough ONC-ACBs to certify 
Complete EHRs for each setting. Therefore, these commenters' support 
for the option was conditioned on the National Coordinator ensuring 
that there were an adequate number of ONC-ACBs for each setting. One 
commenter only supported giving ONC-ACBs an option to certify Complete 
EHRs for either ambulatory or inpatient settings if the option included 
certification of EHR Module level interactions necessary for the 
exchange of data between ambulatory and inpatient Complete EHRs.
    Some commenters stated that the option could lead to ``almost 
complete'' EHRs, which could then lead to eligible professionals and 
eligible hospitals paying large sums for niche EHR Modules based on 
complicated certification criteria such as biosurveillance or quality 
reporting. One commenter asserted that under our current proposal an 
applicant for ONC-ACB status could seek authorization to certify EHR 
Modules that together would essentially constitute a Complete EHR for 
an ambulatory setting (or an inpatient setting). Therefore, the 
commenter contended that we should allow an applicant for ONC-ACB 
status the option to seek authorization to certify Complete EHRs for 
either ambulatory or inpatient settings because an applicant for ONC-
ACB status could essentially choose that option by seeking all the 
necessary EHR Module authorizations for either ambulatory or inpatient 
settings.
    Response. In the Temporary Certification Program final rule, based 
on the concerns expressed by the commenters, we determined that it was 
inappropriate under the temporary certification program to allow 
applicants for ONC-ATCB status to seek authorization to test and 
certify Complete EHRs for either only ambulatory settings or only 
inpatient settings. We stated that we would reconsider the option for 
the permanent certification program based on any additional comments we 
received on the proposed permanent certification program.
    The comments discussed above include comments we received that were 
applicable to both the temporary certification program and the 
permanent certification program as well as comments focused solely on 
the permanent certification program. As mentioned, we discussed the 
comments that were applicable to the temporary

[[Page 1273]]

certification program in the Temporary Certification Program final 
rule. The comments that were focused solely on the permanent 
certification program did not contain any additional information or 
rationale that would cause us to conclude that the option to allow 
applicants for ONC-ACB status to seek authorization to certify Complete 
EHRs for only ambulatory settings or only inpatient settings would be 
appropriate for the permanent certification program. Accordingly, we 
are not permitting this option in the permanent certification program.
    To address the commenters' concerns about ``almost complete'' EHRs, 
we reiterate that for EHR technology to be considered a Complete EHR, 
it must have been developed to meet, at a minimum, all of the 
applicable certification criteria adopted by the Secretary. For 
example, a Complete EHR for an ambulatory setting must have been 
developed to meet all of the certification criteria adopted at Sec.  
170.302 and Sec.  170.304. Therefore, if we were to provide the option 
for ONC-ACBs to seek authorization to certify Complete EHRs for only 
ambulatory settings or only inpatient settings, the Complete EHRs that 
they certify must have been developed to meet all of the applicable 
certification criteria adopted by the Secretary.
    We agree with the commenter that an applicant for ONC-ACB status 
could seek authorization to certify certain types of EHR Modules that 
together could potentially include all of the capabilities required by 
the applicable certification criteria for an ambulatory setting. The 
important distinction between the commenter's suggested approach and 
the option we proposed is that under the commenter's approach the ONC-
ACB would not be able to issue a ``Complete EHR certification'' for a 
combination of EHR Modules because the ONC-ACB had not received 
authorization to certify Complete EHRs. Consequently, if a Complete EHR 
developer wanted to obtain Complete EHR certification, they could not 
seek such certification from an ONC-ACB that did not have authorization 
to grant Complete EHR certifications. We would assume that a potential 
applicant for ONC-ACB status would consider this impact on its customer 
base when determining what type of authorization to seek.
    Consistent with this discussion, we are finalizing proposed Sec.  
170.510 without modification.
b. Integrated Testing and Certification of EHR Modules
    In the Proposed Rule, we requested public comment on whether ONC-
ACBs should be required to certify that any EHR Module presented by one 
EHR Module developer for testing and certification would properly work 
(i.e., integrate or be compatible) with other EHR Modules presented by 
different EHR Module developers.
    Comments. Multiple commenters stated that certifying EHR Modules 
based on their ability to integrate with one another is a worthwhile 
endeavor. These commenters stated that such certification would make it 
easier for eligible professionals and eligible hospitals to purchase 
certified EHR Modules that are compatible and could be used together to 
achieve meaningful use and could increase or improve interoperability 
among HIT in general. Conversely, many other commenters strongly 
disagreed with requiring EHR Modules to be certified for compatibility 
and raised various concerns. Overall, these commenters asserted that it 
would be technically infeasible as well as both logistically (e.g., 
multiple certification sites and multiple EHR Module developers) and 
financially impractical to attempt to certify whether two or more EHR 
Modules were compatible given the huge and shifting numbers of possible 
combinations. Another concern indicated that a mandatory requirement 
for ONC-ACBs to perform this type of certification would be challenging 
for ONC-ACBs because the EHR Module concept as defined in regulation is 
relatively new and because there is limited available guidance and 
mature testing and certification processes for this type of 
certification. One commenter opined that certification was not 
necessary because EHR Module developers would likely strive for 
integration on their own as a marketing tool for their EHR Modules.
    Some commenters suggested that EHR Modules could be certified as 
``integrated bundles.'' One commenter recommended that if we were to 
pursue any type of EHR Module-to-EHR Module integration, it should be 
no earlier than when we adopt the next set of standards, implementation 
specifications, and certification criteria, and then it should only be 
done selectively based on meaningful use requirements. Another 
commenter suggested that ONC-ACBs be given the option, but not be 
required, to determine if EHR Modules are compatible.
    Response. We believe that including a mandatory provision requiring 
ONC-ACBs to certify whether two or more EHR Modules are compatible 
would not be prudent due to the various impracticalities that were 
raised by commenters. We arrived at the same conclusion for the 
temporary certification program as explained in the Temporary 
Certification Program final rule. We believe that requiring ONC-ACBs to 
certify EHR Module-to-EHR Module integration is inappropriate primarily 
because of the impracticalities pointed out by commenters related to 
the numerous combinations of EHR Modules that will likely exist and the 
associated technical, logistical, and financial costs of determining 
EHR Module-to-EHR Module integration. We also agree with the commenter 
who suggested that developers will choose, most likely selectively, to 
integrate their EHR Modules with other EHR Modules for the purposes of 
making their products more marketable. Consequently, we believe that 
the market through business decisions and agreements may work to 
achieve integration where necessary and beneficial.
    An EHR Module developer or developers may present EHR Modules 
together as a pre-coordinated, integrated bundle for certification 
pursuant to Sec.  170.550(e) for the purpose of satisfying the privacy 
and security certification criteria adopted at subpart C of part 170. 
An ONC-ACB, however, is only permitted to certify a pre-coordinated, 
integrated bundle of EHR Modules if it is capable of meeting all of the 
applicable certification criteria and would otherwise meet the 
definition of and constitute a Complete EHR. We assume that the EHR 
Module developer(s), for business and potentially other reasons, would 
have reconciled any compatibility issues among the constituent EHR 
Modules that make up the pre-coordinated, integrated bundle before the 
bundle is presented for testing and certification.
    We note that nothing in this final rule precludes an ONC-ACB or 
other entity from offering a service to certify EHR Module-to-EHR 
Module integration. However, to be clear, although we do not require or 
specifically preclude an ONC-ACB from certifying EHR Module-to-EHR 
Module integration, any EHR Module-to-EHR Module certification 
performed by an ONC-ACB or other entity will be done without specific 
authorization from the National Coordinator and will not be considered 
part of the permanent certification program. We understand that 
certification for EHR Module-to-EHR Module integration may be 
advantageous in certain instances, but

[[Page 1274]]

we do not believe, based on the impracticalities discussed above, that 
we could set all the necessary parameters for certification of EHR 
Module-to-EHR Module integration.
    Consistent with this discussion, we are finalizing proposed Sec.  
170.510 without modification.

G. ONC-ACB Application Process

1. Application
    We proposed in Sec.  170.520 that an application would need to be 
submitted to the National Coordinator and that the application would 
need to contain certain information to be considered complete. We also 
noted that applications would be made available on ONC's Web site and 
could be submitted by e-mail.
    Similar to the temporary certification program, we proposed to 
require an applicant for ONC-ACB status to indicate on its application 
the type of certification it seeks authorization to perform under the 
permanent certification program. Consistent with proposed Sec.  
170.510, an applicant could indicate that it seeks authorization to 
certify Complete EHRs, EHR Module(s), and/or other types of HIT for 
which the Secretary has adopted certification criteria. If the 
applicant were to request authorization to certify EHR Module(s), we 
proposed to require the applicant to identify the type(s) of EHR 
Module(s) that it seeks to certify.
    We proposed that an applicant must provide general identifying 
information, including the applicant's name, address, city, State, zip 
code, and Web site. We proposed that an applicant also must designate 
an authorized representative and provide the name, title, phone number, 
and e-mail address of the person who would serve as the applicant's 
point of contact. We proposed that an applicant must submit 
documentation confirming the applicant's accreditation by an ONC-AA. 
Lastly, we proposed that an applicant must submit an executed agreement 
to adhere to the ``Principles of Proper Conduct for ONC-ACBs.''
    We proposed that if the Secretary adopts certification criteria for 
HIT other than Complete EHRs and EHR Modules, an ONC-ACB would be 
required to submit an addendum to its original application if it wished 
to request authorization to certify this other type of HIT. 
Additionally, we proposed that if a new organization wanted to be 
authorized to certify another type of HIT, it would need to follow the 
rules for becoming an ONC-ACB, including first receiving accreditation 
from an ONC-AA.
    Comments. We received comments expressing agreement with the 
application requirements, including the need for an applicant to be 
accredited before it applies. One commenter suggested that if an 
organization fails to become accredited on the first attempt that the 
organization should be given another opportunity. Another commenter 
suggested that, similar to the temporary certification program, we 
institute a ``proficiency examination'' for ``key personnel.'' The 
commenter stated that such a competency test, adherence to 
credentialing standards such as ASTM International 2659, or a more 
formal and ongoing personnel certification program in accordance with 
ISO 17024 may have long-term benefits for the permanent certification 
program. A commenter also requested clarification on what information 
the National Coordinator would deem sufficient to confirm the 
applicant's accreditation. The commenter suggested that a current 
letter of accreditation, as opposed to the re-submission of supporting 
documentation that was submitted previously to the ONC-AA, could 
fulfill the requirement to confirm an ONC-ACB's accreditation.
    Response. We appreciate the support for the proposed application 
requirements. We wish to further clarify these requirements for 
applicants who seek authorization to certify EHR Modules. In addition 
to identifying the specific type(s) of EHR Module(s) that they wish to 
certify, these applicants are expected to identify as part of their 
application the certification criterion or criteria that they believe 
should be included within the scope of their authorization for the EHR 
Module(s) they have identified. We believe requiring applicants to 
provide this information will ensure that an applicant and the National 
Coordinator will have a shared understanding of the scope of the 
authorization requested by the applicant, which could otherwise be 
difficult to discern based solely on the name(s) or type(s) of EHR 
Module(s) that the applicant identifies in its application.
    In response to the commenter, we note that the ONC-AA will develop 
and manage the accreditation process for organizations that intend to 
apply for ONC-ACB status, including the number of times an organization 
may attempt to become accredited. We appreciate the commenter's 
recommendation for ONC-ACB personnel to undergo competency testing and/
or a formal credentialing program, and we understand the potential 
benefits associated with such requirements. We do not, however, believe 
that ONC should independently require personnel of applicants for ONC-
ACB status to pass a certain exam or possess certain credentials before 
the applicant applies ONC-ACB status. We believe that accreditation by 
the ONC-AA will be sufficient to ensure that an applicant for ONC-ACB 
status will have personnel who are qualified to perform certifications 
of Complete EHRs, EHR Modules, and/or other types of HIT. Further, we 
will require ONC-ACBs to attend ONC mandatory training and to maintain 
training programs for their own personnel, which we believe are 
adequate measures to ensure that ONC-ACB personnel will remain 
competent. Lastly, to properly document an ONC-ACB applicant's 
accreditation, the applicant should provide a copy of its accreditation 
record consistent with the accreditation record that the ONC-AA must 
keep in accordance with section 7.14 of ISO 17011. We believe that a 
copy of the record will allow the National Coordinator to properly 
confirm the extent of an applicant's accreditation.
    In the Temporary Certification Program final rule, we noted a 
commenter's suggestion that we should establish a process that would 
enable ONC-ATCBs to apply for additional authorization to test and 
certify additional types of EHR Modules. We declined to establish a 
process separate from the application process that we had proposed for 
the temporary certification program, but we indicated that we would 
consider whether an alternative process would be appropriate for the 
permanent certification program. In other words, if an ONC-ACB is 
authorized to certify a certain type(s) of EHR Module(s) and wants to 
expand the scope of its current authorization so that it may certify 
other types of EHR Modules, should there be a way for it to obtain this 
authorization without following the application process outlined in 
Sec.  170.520. After considering this possibility, we have decided to 
adopt a more streamlined process for ONC-ACBs that want to expand the 
scope of their current authorization to include Complete EHRs, other 
types of EHR Modules, and/or other types of HIT if it becomes an 
option. In order to request additional authorization under this 
process, an ONC-ACB must specify in writing the type of authorization 
it is seeking (including, for EHR Module(s) authorization, 
identification of the certification criterion or criteria that it 
believes should be included within the scope of its authorization) and 
provide documentation of its current accreditation that would support 
the

[[Page 1275]]

type of authorization it seeks, as described in Sec.  170.520(a) and 
(c), respectively. The ONC-ACB would not be required to resubmit the 
other information specified in Sec.  170.520, unless any of that 
information had changed since it was last provided to ONC. In deciding 
whether to grant an ONC-ACB's request to expand the scope of its 
current authorization, the National Coordinator may also consider 
whether the ONC-ACB has completed any mandatory training as may be 
required by Sec.  170.523(b), which would confirm whether the ONC-ACB 
is competent to certify the specific type(s) of HIT for which it seeks 
authorization. For example, an ONC-ACB that is authorized to certify a 
certain type of EHR Module may request authorization to certify other 
types of EHR Modules that may include different capabilities and thus 
implicate different certification criteria adopted by the Secretary. 
The National Coordinator may require the ONC-ACB to complete mandatory 
training to ensure that the ONC-ACB understands the test tools and test 
procedures used for testing to the different certification criteria and 
can competently certify the other types of EHR Modules. We believe a 
more streamlined process will benefit both ONC-ACBs and developers of 
Complete EHRs, EHR Modules, and other types of HIT because it will 
enable ONC-ACBs to expand the scope of their authorization more 
efficiently and consequently provide additional certification services 
to developers. Overall, we believe this could potentially benefit the 
market for HIT by increasing the speed with which certified Complete 
EHRs, EHR Modules and potentially other types of HIT are available for 
purchase and/or implementation.
    We are revising Sec.  170.520(c) such that the documentation 
provided by the applicant must confirm that the applicant has been 
accredited by ``the ONC-AA,'' instead of ``an ONC-AA'' as proposed. We 
believe the revision more clearly reflects that there will be only one 
ONC-AA at a time.
2. Principles of Proper Conduct for ONC-ACBs
    We received multiple comments on the proposed Principles of Proper 
Conduct for ONC-ACBs. Many of those comments were also relevant to the 
proposed Principles of Proper Conduct for ONC-ATCBs because several 
identical Principles were proposed for both ONC-ACBs and ONC-ATCBs. As 
explained earlier in this preamble, given the similarities that exist 
between the temporary and permanent certification programs, the 
responses we provide below are often similar or identical to our 
responses to comments on the proposed Principles of Proper Conduct for 
ONC-ATCBs that we provided in the Temporary Certification Program final 
rule.
    We did not receive any comments on the Principles of Proper Conduct 
proposed in paragraphs (b), (c) and (d) of Sec.  170.523. Therefore, we 
are finalizing these Principles of Proper Conduct without modification. 
While we received comments on all of the other proposed Principles of 
Proper Conduct for ONC-ACBs and suggestions for additional principles 
of proper conduct, the majority of the comments were focused on or 
related to the proposed Principles that would require ONC-ACBs to 
provide ONC, no less frequently than weekly, a current list of Complete 
EHRs and EHR Modules that have been certified; only certify HIT that 
has been tested by a NVLAP-accredited testing laboratory; and submit an 
annual surveillance plan and annually report surveillance results.
a. Maintain Accreditation
    We proposed in Sec.  170.523(a) that an ONC-ACB would be required 
to maintain its accreditation. As discussed earlier, the ONC-AA will be 
required as part of its ongoing responsibilities to verify that ONC-
ACBs are continuing to operate in accordance with Guide 65 at a minimum 
in order to maintain their accreditation.
    Comments. A few commenters expressed opinions that accreditation 
was an appropriate requirement for ONC-ACBs. One commenter recommended 
that we review the processes of other accreditation organizations such 
as the American National Standards Institute, the Joint Commission, and 
the ISO to assist in the development of the accreditation program for 
the permanent certification program, while another commenter 
recommended that we only require compliance with select, appropriate 
provisions of Guide 65 as part of accreditation instead of all of Guide 
65.
    Response. We have reviewed the processes of other accreditation 
organizations and have concluded, as proposed, that the standards 
developed by the ISO (specifically, ISO 17011 and Guide 65) should 
serve as the foundation for developing the accreditation element of the 
permanent certification program. In particular, we have stated that we 
expect the ONC-AA will accredit ONC-ACBs based on the guidelines 
specified in ISO 17011. Further, we believe that all of the provisions 
of Guide 65 would be applicable to the accreditation program and thus 
we proposed that accreditation would include verification of a 
certification body's conformance, at minimum, to Guide 65. We believe 
that requiring ONC-ACBs to be accredited will ensure that ONC-ACBs are 
qualified to perform certifications and will continue to be capable of 
properly performing certifications.
b. ONC Visits to ONC-ACB Sites
    We proposed in Sec.  170.523(e) to require an ONC-ACB to allow ONC, 
or its authorized agent(s), to periodically observe on site 
(unannounced or scheduled) any certifications performed to demonstrate 
compliance with the requirements of the permanent certification 
program.
    Comments. A commenter expressed agreement with our proposal stating 
that both scheduled and unannounced visits are appropriate. Another 
commenter stated that if visits are unannounced, then there can be no 
assurance that a certification will actually be underway upon the 
arrival of an ONC representative. Therefore, the commenter recommended 
that we should revise the requirement to require an ONC-ACB to respond 
within 2 business days to an ONC request to observe certification by 
providing the date, time, and location of the next scheduled 
certification. Another commenter recommended that all visits should be 
planned because staff may not be available and ``clearances'' may need 
to be arranged well in advance of a site visit. A commenter also stated 
that ONC observers for site visits would likely need to execute 
confidentiality and/or business associate agreements because some HIT 
developers treat their software screens and other elements as trade 
secrets.
    Response. Our proposal gave us the option to conduct either 
scheduled or unannounced visits. After considering the comments, we 
believe it is appropriate to maintain both options, as we did in the 
context of the temporary certification program. If we determine that 
there is a specific certification that would be appropriate for us or 
our authorized agent(s) to observe, we may find it is more prudent to 
schedule a visit. However, to monitor compliance with the provisions of 
the permanent certification program and to maintain the integrity of 
the program, we believe that unannounced visits are appropriate. We 
anticipate that ONC ``authorized agents'' could potentially include 
individuals or entities under contract with ONC, personnel from an 
entity with which ONC has a regulatory relationship (e.g., personnel 
from the

[[Page 1276]]

ONC-AA), or personnel from other Federal agencies with certification 
expertise (e.g., NIST). We expect to establish ahead of time for ONC-
ACBs the parameters around announced or unannounced on-site visits. In 
establishing these parameters, we expect ONC-ACBs to ensure that any 
``clearances'' for ONC or its authorized agents are obtained in a 
timely manner given the possibility of an unannounced site visit. We 
also expect ONC-ACBs will take the necessary steps to address any 
potential confidentiality issues with their customers (for example, 
through a confidentiality agreement that would enable ONC and its 
authorized representatives to observe the certification of a customer's 
HIT). Therefore, we are finalizing this Principle of Proper Conduct 
with only a minor modification. We are revising Sec.  170.523(e) to 
clarify that site visits will be conducted during normal business 
hours. This condition was inadvertently left out of the proposed 
provision, but is consistent with our original intent as shown in the 
proposed and final versions of the analogous provision for ONC-ATCBs.
c. Lists of Certified Complete EHRs and EHR Modules
i. ONC-ACB Lists
    We proposed in Sec.  170.523(f) to require an ONC-ACB to provide 
ONC, no less frequently than weekly, a current list of Complete EHRs 
and/or EHR Modules that have been certified which includes, at a 
minimum, the vendor name (if applicable), the date certified, the 
product version, the unique certification number or other specific 
product identification, and where applicable, the certification 
criterion or certification criteria to which each EHR Module has been 
certified.
    Comments. Many commenters expressed appreciation for the proposed 
requirement and the proposed frequency for which the lists were to be 
updated. In relation to the information ONC-ACBs must report, a 
commenter specifically expressed support for making timely, complete, 
and useful information available to eligible professionals and eligible 
hospitals as they purchase and implement Certified EHR Technology that 
will enable them to attempt to demonstrate meaningful use.
    Some commenters requested clarification and made recommendations 
for revisions to the provision. One commenter suggested that the 
provision should be revised to require an ONC-ACB to notify ONC within 
a week of successful certification of new Complete EHRs and/or EHR 
Modules. Additionally, the commenter contended that the proposed 
provision was unclear as to whether an ONC-ACB was required to send a 
complete, current list or only new additions and whether the list could 
be sent via e-mail. Another commenter suggested revising the provision 
to require an ONC-ACB to also report a current list of ``applicants'' 
and their status in the certification queue.
    Response. As proposed and as already finalized for the temporary 
certification program, we will require ONC-ACBs to provide the National 
Coordinator, no less frequently than weekly, with a current list of 
Complete EHRs and/or EHR Modules that have been certified. We 
anticipate only requiring weekly updates, but ONC-ACBs are free to 
provide more frequent updates. We believe weekly updates are sufficient 
for providing current information to the public on the status of 
certified Complete EHRs and EHR Modules without placing an 
administrative burden on ONC-ACBs. In this regard, we have previously 
stated and continue to expect that ONC-ACBs will provide the 
information electronically, such as through e-mail. We also agree with 
the commenter that it would be unnecessary for an ONC-ACB to continue 
to report on previously certified Complete EHRs and/or EHR Modules and, 
therefore, only expect these weekly reports to include new 
certifications issued between the last weekly report and the newly 
submitted weekly report. Additionally, we do not believe any 
substantial benefit would result from requiring ONC-ACBs to report on 
the status of Complete EHRs and/or EHR Modules that are in the process 
of being certified. The time needed for the certification of Complete 
EHRs and EHR Modules will likely vary based on many factors and, in 
some cases, may not be completed due to various reasons. Therefore, we 
do not believe that the reporting of products in an ONC-ACB's queue 
should be a requirement at this time.
    We agree with the commenter who indicated that useful information 
should be made available to eligible professionals and eligible 
hospitals as they decide which Certified EHR Technology to adopt. We 
note that much of the information that will be reported by ONC-ACBs 
will also be included in the Certified HIT Products List (CHPL) that 
will be made publicly available on ONC's Web site. After consideration 
of the public comments received and our own programmatic objectives, we 
will require ONC-ACBs to report information related to the two 
additional elements that we already finalized for ONC-ATCBs in the 
Temporary Certification Program final rule. Our intention in including 
these two additional elements is to make more information widely 
available about the technology that has been certified, which will 
benefit eligible professionals, eligible hospitals, and other 
interested parties who wish to adopt certified Complete EHRs and EHR 
Modules. The two additional elements that we will require ONC-ACBs to 
report are the clinical quality measures to which a Complete EHR or EHR 
Module has been certified and, where applicable, any additional 
software that a Complete EHR or EHR Module relied upon to demonstrate 
its compliance with a certification criterion or criteria adopted by 
the Secretary. As with the other information that ONC-ACBs must report, 
these two additional elements will enable eligible professionals and 
eligible hospitals to make better informed purchasing decisions, 
consistent with the commenter's suggestion.
    The reporting of clinical quality measures to which a Complete EHR 
or EHR Module has been certified will enable an eligible professional 
or eligible hospital to identify and adopt a Complete EHR or EHR Module 
that includes the clinical quality measures they seek to implement. 
Knowledge of the additional software a Complete EHR or EHR Module has 
relied upon to demonstrate compliance with a certification criterion or 
criteria will be useful, and in some cases essential, for eligible 
professionals and eligible hospitals who are deciding which Complete 
EHR or EHR Module to adopt. Eligible professionals and eligible 
hospitals could use this information to assess whether a specific 
certified Complete EHR or EHR Module may be incompatible with their 
current information technology (IT) or would require them to install 
additional IT. We stress that this reporting requirement only relates 
to software that is relied upon by a Complete EHR or EHR Module to 
demonstrate compliance with a certification criterion or criteria 
adopted by the Secretary. We do not intend or expect this requirement 
to be construed as a comprehensive specifications list or similar type 
of inclusive list. Rather, as with the temporary certification program, 
our rationale for including this requirement is to ensure that eligible 
professionals and eligible hospitals who adopt a certified Complete EHR 
or EHR Module understand what is necessary for the Complete EHR or EHR 
Module to

[[Page 1277]]

operate in compliance with the certification criterion or criteria to 
which it was certified. For example, if a Complete EHR relied upon an 
operating system's automatic log-off functionality to demonstrate its 
compliance with this certification criterion, we would expect the 
operating system relied upon to be reported. Conversely, if a Complete 
EHR included its own automatic log-off capability, even though the 
Complete EHR may have been certified using a particular operating 
system, we would not require the operating system to be reported 
because it was not relied upon to demonstrate compliance with the 
certification criterion.
    We are revising Sec.  170.523(f) to correct an inadvertent 
reference to vendors of Complete EHRs or EHR Modules. As proposed, the 
section would require ONC-ACBs to report the names of certified 
Complete EHR or EHR Module vendors, if applicable. Our use of the word 
``vendor'' was not intended to exclude information related to self-
developers from the reporting requirements of Sec.  170.523(f). 
Throughout the Proposed Rule and this final rule, we have collectively 
referred to self-developers and commercial vendors as ``developers'' of 
Complete EHRs and EHR Modules. Therefore, we are replacing ``vendor'' 
with ``Complete EHR or EHR Module developer'' in Sec.  170.523(f)(1).
    We also believe it would be helpful to clarify the specific 
information that should be reported with respect to pre-coordinated, 
integrated bundles of EHR Modules that are certified in accordance with 
Sec.  170.550(e). ONC-ACBs are required by Sec.  170.523(f)(4) to 
report the unique certification number or other specific product 
identification of Complete EHRs and EHR Modules that have been 
certified. They are also required by Sec.  170.523(f)(7) to report, 
where applicable, the certification criterion or criteria to which each 
EHR Module has been certified. Based on these provisions, ONC-ACBs 
should identify and include in their reports to the National 
Coordinator: the pre-coordinated, integrated bundles of EHR Modules 
that they certify; the list of constituent EHR Modules that comprise 
each bundle; and, where applicable, identify for each constituent EHR 
Module the certification criterion or criteria to which that particular 
EHR Module has been certified.
    Finally, as with the temporary certification program, we note that 
our required reporting elements constitute a minimum. We do not 
preclude ONC-ACBs from including in their weekly reports additional 
information that prospective purchasers and users of Complete EHRs and 
EHR Modules would find useful, such as specifying the Complete EHR or 
EHR Module's compatibility with other software or compatibility with 
other EHR Modules. If not reported to the National Coordinator, we 
encourage ONC-ACBs to consider making such information available on 
their own Web sites to better inform prospective purchasers and users 
of Complete EHRs and EHR Modules.
    We are revising Sec.  170.523(f) consistent with our discussion 
above.
ii. Certified HIT Products List
    We stated in the Proposed Rule that in an effort to make it easier 
for eligible professionals and eligible hospitals to cross-validate 
that they have in fact adopted Certified EHR Technology, the National 
Coordinator intends to make a master CHPL of all Complete EHRs and EHR 
Modules certified by ONC-ACBs available on the ONC Web site. The CHPL 
would be a public service and would be a single, aggregate source of 
all the certified product information ONC-ACBs provide to the National 
Coordinator. The CHPL would also represent all of the Complete EHRs and 
EHR Modules that could be used to meet the definition of Certified EHR 
Technology. We also noted that, over time, we anticipate adding 
features to the Web site, which could include interactive functions to 
help eligible professionals and eligible hospitals determine whether a 
particular combination of certified EHR Modules could potentially 
qualify as Certified EHR Technology.
    Comments. Many commenters expressed support for our decision to 
create a list of certified Complete EHRs and EHR Modules and to post a 
link to that list on our Web site. Many commenters also provided 
recommendations for how to enhance the list. One commenter endorsed an 
online system whereby physicians could type in or select information on 
the Complete EHR or EHR Module they planned on using to determine 
whether their selected combination would enable them to meet the CMS 
Medicare and Medicaid EHR Incentive Programs requirements. The 
commenter reasoned that the steps were necessary because eligible 
professionals, especially in smaller practices, did not have the 
technical expertise or support to ascertain whether or not a Complete 
EHR, EHR upgrades, EHR Module(s), or a combination of EHR Modules would 
enable them to perform the meaningful use requirements. Another 
commenter requested an explicit commitment from ONC that the use of 
certified Complete EHRs and/or EHR Modules on the CHPL will support 
their ability to report all required meaningful use measures.
    Some commenters expressed a preference that the CHPL contain 
information on the capabilities of certified Complete EHRs and EHR 
Modules associated with adopted certification criteria. Other 
commenters requested that the CHPL contain information on whether 
certified Complete EHRs or EHR Modules are compatible with other types 
of HIT. In particular, commenters stated that it was important to 
eligible professionals and eligible hospitals for Complete EHR and EHR 
Module developers to fully disclose the functions for which their 
products are certified, which software components are necessary to meet 
certification criteria, and to also fully disclose any compatibility 
issues. A few commenters also suggested that the CHPL contain data on 
usability features of certified Complete EHRs and EHR Modules.
    One commenter recommended that ONC and each ONC-ACB maintain a list 
of certified Complete EHRs and EHR Modules. Another commenter 
recommended that, in order to prevent the conveyance of potentially 
inaccurate information and confusion in the market, an ONC-ACB should 
not maintain on its own Web site a current list of the Complete EHRs 
and/or EHR Modules that it has certified, but instead reference the 
CHPL on ONC's Web site for the complete list of certified Complete EHRs 
and EHR Modules.
    Response. We appreciate the commenters' support for the CHPL and 
their recommendations for its enhancement. As previously explained in 
the Temporary Certification Program final rule, we intend for the CHPL 
to be a single, aggregate source of all certified Complete EHRs and EHR 
Modules reported by ONC-ACBs to the National Coordinator. The CHPL will 
include all of the certified Complete EHRs and EHR Modules that could 
be used to meet the definition of Certified EHR Technology. It will 
also include the other pertinent information we require ONC-ACBs to 
report to the National Coordinator, such as a certified Complete EHR's 
version number. Eligible professionals and eligible hospitals that 
elect to use a combination of certified EHR Modules may also use the 
CHPL webpage to validate whether the EHR Modules they have selected 
satisfy all of the applicable certification criteria that are necessary 
to meet the definition of Certified EHR Technology. The CHPL webpage 
will include a unique identifier (e.g., an alphanumeric

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identifier) for each certified Complete EHR and each combination of 
certified EHR Modules that meets the definition of Certified EHR 
Technology. The unique identifier provided by the CHPL webpage could 
subsequently be used to submit to CMS for attestation purposes.
    Consistent with the temporary certification program, we believe 
that only ONC should maintain the CHPL to ensure that the CHPL is 
accurate and comprehensive. However, we do not believe that it is 
appropriate to preclude an ONC-ACB from maintaining on its own Web site 
a list of Complete EHRs and/or EHR Modules that it certified. An ONC-
ACB's own list could have benefits for the market in identifying the 
specific ONC-ACB that certified a Complete EHR or EHR Module. The ONC-
ACB may also create a link on its Web site to the CHPL, which 
conceivably would be a user-friendly feature.
d. Records Retention
    We proposed in Sec.  170.523(g) to require an ONC-ACB to retain all 
records related to the certification of Complete EHRs and/or EHR 
Modules for a minimum of 5 years.
    Comments. Commenters recommended that our records retention 
requirement be consistent with CMS's requirement for eligible 
professionals and eligible hospitals who seek to qualify for Medicare 
or Medicaid incentive payments for meaningful use, plus an additional 
two years to ensure that records are available during an audit process.
    Response. As stated in the Proposed Rule, the record retention 
requirement is based on our consultations with NIST regarding standard 
industry practice. As also stated in the Proposed Rule, the purpose of 
our records retention requirement is twofold. An ONC-ACB's records 
would be directly relevant to a determination by the National 
Coordinator that the ONC-ACB committed a Type-2 violation and/or to 
revoke the ONC-ACB's status. Second, ONC-ACBs' certification records 
will likely be necessary for ONC-ACBs to conduct surveillance under the 
permanent certification program. In addition to the records retention 
requirement of Sec.  170.523(g), ONC-ACBs are expected to retain 
records consistent with the terms of their accreditation, which will 
include the requirements of Guide 65. Lastly, our records retention 
requirement should be construed as an independent requirement and is 
not intended to replace or supplant any other requirements imposed by 
law or otherwise agreed to by ONC-ACBs. Accordingly, we will, as 
proposed, require ONC-ACBs to retain all records related to the 
certification of Complete EHRs and/or EHR Modules for a minimum of 5 
years.
e. NVLAP-Accredited Testing Laboratory
    In the Proposed Rule, we proposed to separate the responsibilities 
for testing and certification in the permanent certification program. 
We proposed that the National Coordinator's authorization granted to 
ONC-ACBs under the permanent certification program would not extend to 
the testing of Complete EHRs or EHR Modules. Instead, we proposed that 
the National Voluntary Laboratory Accreditation Program (NVLAP), as 
administered by NIST, would be responsible for accrediting testing 
laboratories and determining their competency. In this role, NVLAP 
would be solely responsible for overseeing accreditation activities 
related to testing laboratories for purposes of the permanent 
certification program. We mentioned NVLAP's experience with developing 
specific laboratory accreditation programs (LAPs) for testing and 
calibration laboratories in response to legislative or administrative 
actions, requests from government agencies or, in special 
circumstances, from private sector entities. We proposed that the 
National Coordinator would decide whether to issue a request to NVLAP 
to develop a LAP for testing laboratories after considering public 
comments on our proposals for the permanent certification program. To 
ensure that ONC-ACBs review test results from legitimate and competent 
testing laboratories, we further proposed in Sec.  170.523(h) to 
require ONC-ACBs to only certify HIT, including Complete EHRs and/or 
EHR Modules, that has been tested by a NVLAP-accredited testing 
laboratory.
    We received a number of comments on these proposals and have 
divided them into two categories: Separation of testing and 
certification; and accreditation, test tools and test procedures, and 
ONC-ACBs' permitted reliance on certain test results.
i. Separation of Testing and Certification
    Comments. Commenters expressed general support for our proposal to 
establish a permanent certification program that includes the use of 
independent, accredited testing laboratories. Commenters stated that 
the separation of the testing and certification processes will provide 
more transparency and result in a more rigorous permanent certification 
program. Conversely, a few commenters were not certain that separation 
or an accredited testing process were even necessary. One of these 
commenters was concerned that separation would lead to increased costs, 
particularly for self-developers that will require on-site testing and 
certification. Another commenter was concerned that separation, if not 
managed properly, could unintentionally result in confusion and delay 
the certification of HIT products. Although a commenter assumed that 
HIT products will be tested before they are certified, the commenter 
noted that we did not clearly delineate the order of testing and 
certification in the Proposed Rule.
    Response. We appreciate the comments of support for our proposal to 
separate the testing process from the certification process in the 
permanent certification program. We believe that the separation of 
testing laboratories and certification bodies is appropriate because it 
will result in a more transparent and demanding permanent certification 
program, as the commenters noted. We also believe these program 
qualities will be enhanced by the use of specialized accreditation 
organizations from the private sector to accredit the certification 
bodies that ultimately will become ONC-ACBs. As discussed in the 
Proposed Rule, these accreditation organizations will be better 
equipped than ONC to react effectively and efficiently to changes in 
the HIT market and rigorously oversee the certification bodies they 
accredit. Additionally, as noted in the Proposed Rule, we have observed 
in other industries, such as the manufacturing of water-conserving 
products, that testing and certification processes are typically 
handled independently and separately.
    We expect that the separation of testing and certification will be 
managed properly by accredited testing laboratories and ONC-ACBs, 
respectively, and will not lead to undue delays or confusion. If 
necessary, we may issue program guidance at some point in the future in 
order to address questions or confusion about the elements and 
processes of the permanent certification program as well as the 
eventual transition from testing and certification under the temporary 
certification program. As for possible delays, we believe that any 
customer and/or product could experience delays under a testing and 
certification program for various reasons, but we do not anticipate any 
undue delays that would be specifically attributable to the separation 
of testing and certification under the permanent certification program. 
We expect that the ONC-ACBs

[[Page 1279]]

and accredited testing laboratories, having achieved accreditation, 
will have the ability to manage requests for certification and testing, 
respectively, in a timely manner. We also expect that these bodies will 
be able to answer questions about requests for certification and/or 
testing, as applicable, and provide other guidance to HIT developers 
based on the training and instruction they receive from ONC and NVLAP.
    We appreciate the commenter's concern about the potential costs of 
testing and certification. The commenter seems to suggest that the 
costs associated with the testing and certification of Complete EHRs 
and EHR Modules will be higher because of the separation of the testing 
and certification processes, particularly for self-developers. We agree 
that the costs to Complete EHR and EHR Module developers could 
potentially increase due to the separation of the testing and 
certification processes, but we believe that any potential increases 
will not be prohibitive for developers. Our Regulatory Impact Analysis 
(RIA) in both the Proposed Rule and this final rule accounts for 
potential cost increases due to the separation of the testing and 
certification processes. The RIA states that our estimated costs for 
the testing and certification of Complete EHRs and EHR Modules under 
the permanent certification program include the costs of separate 
testing and certification as well as on-site testing and certification. 
We have provided a range for the potential costs of testing and 
certification under the permanent certification program. We did not 
receive any comments demonstrating that the costs associated with 
testing and certification will be higher than our estimates in the 
Proposed Rule because of the separation of the testing and 
certification processes. In addition, the actual costs of testing and 
certification may be lower than our estimates due to factors such as 
competitive pricing and/or lower costs attributable to gap 
certification. We further discuss the processes and costs associated 
with gap certification in section P. Differential or Gap Certification 
and in the RIA. Lastly, we note that ONC-ACBs may also become 
accredited testing laboratories under the permanent certification 
program, which may result in costs savings for developers that choose 
to have their Complete EHR and/or EHR Module tested and certified by 
the same organization.
    The commenter correctly assumed that Complete EHRs and EHR Modules 
must first be tested before they can be certified under the permanent 
certification program. As we discussed in the Proposed Rule and this 
final rule, the concept of ``certification'' requires an ONC-ACB to 
analyze the quantitative results of testing and subsequently assess 
whether a Complete EHR or EHR Module has met all of the applicable 
certification criteria adopted by the Secretary. The chronological 
order of testing and certification is also addressed in Sec.  
170.523(h), which requires an ONC-ACB to only certify HIT that has been 
tested in accordance with the provisions of that section. For these 
reasons, it would be impracticable for a Complete EHR or EHR Module to 
be certified by an ONC-ACB before it undergoes testing.
ii. Accreditation, Test Tools and Test Procedures, and ONC-ACBs' 
Permitted Reliance on Certain Test Results
    Comments. Commenters generally requested more information about the 
accreditation of testing laboratories under the permanent certification 
program. One commenter asked whether NVLAP will develop a specific 
field of accreditation for EHR technology and whether it will provide 
an application for entities interested in becoming an accredited 
testing laboratory. Another commenter supported our proposal to ask 
NVLAP to develop a LAP and requested that the LAP be designed 
specifically for Complete EHR and EHR Module testing. Commenters 
requested that we provide detailed information explaining how ONC and 
NIST will coordinate efforts to ensure that the accredited testing 
laboratories overseen by NVLAP are established within a timeframe that 
is consistent with ONC's efforts to authorize certification bodies. The 
commenters also requested information explaining how it will be 
determined whether testing laboratories have sufficient technical 
expertise and capacity to support the demand for testing in a timely 
manner. Many commenters recommended that testing laboratories be 
required to offer remote and on-site testing. Additionally, a commenter 
requested guidance as to how an ONC-ACB would know that a testing 
organization is NVLAP-accredited and suggested listing NVLAP-accredited 
testing laboratories on ONC's Web site as a reasonable solution.
    Response. As discussed in the Proposed Rule, section 3001(c)(5) of 
the PHSA authorizes the National Coordinator, in consultation with the 
Director of NIST, to establish a program or programs for the voluntary 
certification of HIT, and such program(s) ``shall include, as 
appropriate, testing of the technology in accordance with section 
13201(b) of the [HITECH] Act.'' Section 13201(b) of the HITECH Act 
provides that the Director of NIST, in coordination with the HIT 
Standards Committee, ``shall support the establishment of a conformance 
testing infrastructure * * *, '' the development of which ``may include 
a program to accredit independent, non-Federal laboratories to perform 
testing.'' Consistent with this statutory authority, we are finalizing 
our proposal that NVLAP, as administered by NIST, will be responsible 
for establishing and managing a program for the accreditation of 
laboratories to perform HIT testing under the permanent certification 
program.
    As noted in the Proposed Rule, we are confident that NVLAP has the 
necessary scientific staff with specialized technical capabilities to 
develop an accreditation program for the testing of HIT. NVLAP has been 
responsible for developing a biometrics LAP for the Department of 
Homeland Security, a program to accredit laboratories for conducting 
security evaluations for the National Security Agency, a program to 
accredit laboratories to test hardware and software for voting systems, 
as well as many other programs for accrediting testing laboratories in 
response to Federal agencies' requests. Additionally, NIST scientific 
staff has exhibited their expertise with HIT by developing the test 
tools and test procedures for the temporary certification program. 
Based on our discussions with NIST, these experts will also be involved 
in developing the LAP for the permanent certification program. Given 
the demonstrated scope of NVLAP's and NIST's technical expertise, the 
National Coordinator will request that NVLAP develop a LAP specifically 
for HIT and the permanent certification program. The National 
Coordinator anticipates that the LAP will align with the programmatic 
goals of the permanent certification program, including the program's 
current focus on EHR technology.
    We are currently working closely with NIST to achieve programmatic 
objectives related to the testing of Complete EHRs and EHR Modules 
under the temporary certification program. We expect this close 
relationship and degree of coordination will extend into the permanent 
certification program as the HIT LAP is developed. To further align our 
efforts with NIST, we are issuing this final rule a year in advance of 
the anticipated sunset of the temporary certification program and the 
start of testing and certification under the permanent certification 
program. During this period

[[Page 1280]]

of time, we expect NVLAP will develop the HIT LAP for the permanent 
certification program after receiving the National Coordinator's 
request and will subsequently begin the accreditation of testing 
laboratories. We also expect to complete the process of approving the 
ONC-AA during this timeframe, which will enable certification bodies to 
attempt to become accredited and apply for ONC-ACB status.
    We anticipate that NVLAP, based on their aforementioned experience 
in developing other LAPs, will develop a LAP for the permanent 
certification program that will ensure accredited testing laboratories 
have the necessary technical expertise and the capacity to support 
market demand. We also anticipate that NVLAP will take into account 
current HIT industry testing practices and market demands, such as the 
use of remote testing and the need for on-site testing in some 
instances, when developing the LAP for accrediting testing 
laboratories. Even if the LAP developed by NVLAP does not expressly 
address remote and/or on-site testing, we expect accredited testing 
laboratories would offer such testing options if there was market 
demand. Lastly, as the commenter recommended, we expect to coordinate 
efforts with NIST and NVLAP to ensure that the public is made aware of 
NVLAP-accredited testing laboratories by listing them on our respective 
Web sites and identifying them through other appropriate means.
    Comments. Commenters requested more specificity about the 
development and implementation of test tools, test procedures, and test 
scripts. Commenters requested clarity as to whether NIST, the 
accredited testing laboratories, or another entity would be responsible 
for developing the test tools and test procedures. One commenter stated 
that if NIST would be responsible, then NIST should provide information 
on how it will address the testing of open source Complete EHRs and EHR 
Modules. Some commenters recommended that a collaborative process be 
used in the development and implementation of test tools and test 
procedures. A commenter suggested that we create an advisory body for 
the development of test tools and test procedures, while other 
commenters suggested that consultations with Standards Development 
Organizations (SDOs) should be a requirement. One commenter recommended 
the use of the EHR System Functional Model (EHR-S FM). Alternatively, 
most commenters simply requested an open, transparent and industry 
consensus-based approach to developing and implementing test methods 
that allows for a user-friendly feedback process. Another commenter 
requested that we ensure that states be prohibited from requiring 
separate and additional testing processes.
    Response. We can assure commenters that, as with the temporary 
certification program, only test tools and test procedures that have 
been approved by the National Coordinator can be used to test Complete 
EHRs, EHR Modules and potentially other types of HIT in order for them 
to be eligible for certification by an ONC-ACB under the permanent 
certification program. This requirement is imposed on ONC-ACBs under 
Sec.  170.523(h). We believe by having the National Coordinator approve 
test tools and test procedures, we will ensure the best test tools and 
test procedures are utilized. We also believe the National 
Coordinator's approval will instill greater certainty and confidence in 
developers and users of Complete EHRs, EHR Modules and other types of 
HIT. Lastly, we believe that by having the National Coordinator approve 
the test tools and test procedures for the permanent certification 
program, we can provide greater consistency in the testing of Complete 
EHRs, EHR Modules and potentially other types of HIT.
    In the Temporary Certification Program final rule, we adopted a 
process for approving test tools and test procedures, and we intend to 
use this same process for the permanent certification program. For the 
permanent certification program, a person or entity may submit a test 
tool and/or test procedure to the National Coordinator to be considered 
for approval to be used by NVLAP-accredited testing laboratories. The 
submission should identify the developer of the test tool and/or test 
procedure; specify the certification criterion or criteria that is/are 
addressed by the test tool and/or test procedure; and explain how the 
test tool and/or test procedure would evaluate a Complete EHR's, EHR 
Module's, or if applicable, other type of HIT's compliance with the 
applicable certification criterion or criteria. The submission should 
also provide information describing the process used to develop the 
test tool and/or test procedure, including any opportunity for the 
public to comment on the test tool and/or test procedure and the degree 
to which public comments were considered. In determining whether to 
approve a test tool and/or test procedure for purposes of the permanent 
certification program, the National Coordinator will consider whether 
it is clearly traceable to a certification criterion or criteria 
adopted by the Secretary; whether it is sufficiently comprehensive 
(i.e., assesses all required capabilities) for NVLAP-accredited testing 
laboratories to use in testing a Complete EHR's, EHR Module's, or other 
type of HIT's compliance with the certification criterion or criteria 
adopted by the Secretary; whether an appropriate public comment process 
was used during the development of the test tool and/or test procedure; 
and any other relevant factors. When the National Coordinator has 
approved test tools and/or test procedures for purposes of the 
permanent certification program, we will publish a notice of 
availability in the Federal Register and identify the approved test 
tools and test procedures on the ONC Web site.
    Once test tools and test procedures have been approved by the 
National Coordinator, we expect NVLAP-accredited testing laboratories 
will have some degree of responsibility and flexibility to configure 
their own test scripts (i.e., specific scenarios using the approved 
test tools and test procedures). This could involve, for example, the 
creation of a testing sequence that a NVLAP-accredited testing 
laboratory believes is the most efficient way to test a certain suite 
of capabilities. Of course, this responsibility and flexibility may be 
constrained by the accreditation requirements applicable to the NVLAP-
accredited testing laboratories. Given the level and types of 
adjustments that have been made by ONC-ATCBs for the temporary 
certification program, we do not believe that it will be possible for 
NVLAP-accredited testing laboratories to include significant variations 
in their test scripts such that a Complete EHR or EHR Module will pass 
a test administered by one laboratory but fail a test administered by a 
different laboratory.
    Based on our stated approach to the development of test tools and 
test procedures under the permanent certification program, we do not 
believe that an advisory board will be necessary for the development of 
test tools and test procedures. In deciding whether to approve specific 
test tools and test procedures, the National Coordinator will consider 
whether public feedback was a part of the process for developing those 
tools and procedures. Although public feedback could take many 
different forms, we expect it might potentially include some or all of 
the methods that were mentioned by the commenters (e.g., transparent 
processes, collaborative and HIT industry consensus-based approaches, 
consultations with SDOs, and/or utilization of EHR-S FM). In response 
to commenters' questions about NIST's

[[Page 1281]]

role in the development of test tools and test procedures, we 
anticipate that many of the test tools and test procedures that were 
developed by NIST and approved for the temporary certification program 
will likely be applicable to and may be approved for use in performing 
testing under the permanent certification program, particularly if the 
adopted certification criteria have not been revised when testing 
begins under the permanent certification program. As for the future 
development of test tools and test procedures, we expect to continue to 
consult with NIST in the development of test tools and test procedures 
as needed for the testing of HIT to new and/or revised certification 
criteria adopted by the Secretary. In addition, as previously 
discussed, any person or entity may submit test tools and test 
procedures for the National Coordinator's consideration for use in the 
permanent certification program. We expect that open source Complete 
EHRs and EHR Modules will be tested in the same manner as proprietary 
Complete EHRs and EHR Modules because we intend for them to be 
certified in the same manner as proprietary Complete EHRs and EHR 
Modules. Lastly, we are not familiar with State law requirements that 
may be applicable to testing laboratories and thus are unable to 
provide a fully informed response to the commenter's suggestion.
    Comments. Commenters recommended that only one accreditor be 
permitted to accredit testing laboratories in order to ensure 
consistency in the accreditation process. Multiple commenters supported 
the recognition of NVLAP as the accreditor, pointing out that NVLAP is 
an internationally recognized testing laboratory accreditation program, 
while other commenters objected to the use of NVLAP as the sole 
accreditor. The commenters stated that there are at least 4 laboratory 
accreditation bodies in the United States that are considered 
equivalent to NVLAP under the International Laboratory Accreditation 
Cooperation (ILAC) Mutual Recognition Arrangement (MRA). The commenters 
asserted that, as a signatory to the ILAC MRA, NVLAP is obligated to 
promote the acceptance of other signatories' accreditations as being 
equivalent to their own. Further, the commenters recommended that the 
current proposal for ONC-ACBs to certify only HIT that has been tested 
by a NVLAP-accredited testing laboratory should be rescinded and 
replaced with a principle of proper conduct that allows ONC-ACBs to 
certify HIT that has been tested by testing laboratories accredited by 
any ILAC MRA signatory. Possibly as an alternative approach, one of 
these commenters suggested that NVLAP could validate and acknowledge 
the other accreditations by ILAC MRA signatories and thereby authorize 
those accredited testing laboratories to conduct the testing of 
Complete EHRs and/or EHR Modules under the permanent certification 
program. The commenter asserted that such an approach would be 
consistent with the ILAC MRA.
    Response. We strongly believe, as supported by the commenters, that 
consistency in accreditation will be an important element of the 
permanent certification program. We have already demonstrated our 
commitment to such consistency by concluding that there should be only 
one ONC-AA at a time. Similarly, we believe that there should be only 
one accreditor for testing laboratories under the permanent 
certification program. We believe NVLAP is the best qualified 
accreditation organization to fill the role of the sole accreditor for 
testing laboratories based on the reasons we articulated above in 
support of our decision to ask NVLAP to develop a HIT LAP for the 
permanent certification program.
    We disagree with the commenters' suggestion that ONC-ACBs should be 
allowed to rely on testing results from laboratories that have been 
accredited by any signatory to the ILAC MRA. Although commenters stated 
that other accreditation bodies are considered to be equivalent to 
NVLAP based on the ILAC MRA, we are unable to independently verify this 
assertion and thus cannot rely on it for purposes of assessing the 
competence of other accreditation bodies. More importantly, as 
previously discussed, the use of multiple accreditation bodies may 
undermine our programmatic goal of ensuring consistency in 
accreditation. Further, considering that the National Coordinator 
intends to ask NVLAP to develop a HIT LAP, requiring ONC-ACBs to use 
test results from NVLAP-accredited testing laboratories will ensure 
accreditation is performed according to a LAP that the National 
Coordinator believes is appropriate for the permanent certification 
program. As for the commenter's suggestion that NVLAP could validate 
and acknowledge the accreditations of testing laboratories by ILAC MRA 
signatories, we believe such a decision would be within the purview of 
NVLAP. Under Sec.  170.523(h), ONC-ACBs are only permitted to certify 
HIT that was tested by a NVLAP-accredited testing laboratory or, in 
certain circumstances, by an ONC-ATCB. For purposes of that section, a 
testing laboratory must be accredited by NVLAP in accordance with the 
HIT LAP that the National Coordinator will ask NVLAP to develop. NVLAP 
could decide to pursue the approach of validating or acknowledging the 
testing laboratory accreditations of ILAC MRA signatories. In order for 
an ONC-ACB to certify HIT that was tested by one of those testing 
laboratories, however, the testing laboratory must also receive a 
separate accreditation from NVLAP.
    Consistent with this discussion, we are revising Sec.  170.523(h) 
to state that an ONC-ACB may only certify HIT, including Complete EHRs 
and/or EHR Modules, that has been tested by a NVLAP-accredited testing 
laboratory using test tools and test procedures that have been approved 
by the National Coordinator. We are also revising Sec.  170.523(h) to 
allow ONC-ACBs, under certain circumstances, to rely on testing that 
has been performed by ONC-ATCBs, which must also have been done using 
test tools and test procedures that have been approved by the National 
Coordinator. The circumstances when an ONC-ACB may rely on testing 
performed by an ONC-ATCB are more fully discussed under sections O. 
Validity of Complete EHR and EHR Module Certification and Expiration of 
Certified Status and P. Differential or Gap Certification of this 
preamble.
f. Surveillance
    We proposed that ONC-ACBs would be required to conduct surveillance 
of Complete EHRs and/or EHR Modules that they had previously certified. 
As part of its surveillance efforts, we proposed in Sec.  170.523(i) to 
require an ONC-ACB to submit an annual surveillance plan to the 
National Coordinator and annually report to the National Coordinator 
its surveillance results. Noting that ONC-ACBs will be accredited to 
the requirements of Guide 65 at a minimum, we stated that we expect 
ONC-ACBs to perform surveillance in accordance with Guide 65 at a 
minimum, which in section 13 provides that the ``certification body [or 
`ONC-ACB'] shall periodically evaluate the marked [or `certified'] 
products to confirm that they continue to conform to the [adopted] 
standards.'' We further clarified that this would require ONC-ACBs to 
evaluate and reevaluate previously certified Complete EHRs and/or EHR 
Modules to determine whether the Complete EHRs and/or EHR Modules they 
had certified in a controlled environment also performed in an 
acceptable, if not the same, manner in the field.

[[Page 1282]]

    We proposed that the ONC-AA must have processes in place to ensure 
that the certification bodies it accredits properly conduct 
surveillance. In this regard, we stated that ONC-ACBs should be given 
the flexibility to conduct surveillance in accordance with their 
accreditation. We acknowledged that the HIT industry could potentially 
benefit from the development of common elements of surveillance and 
requested comments on what those elements should include as well as 
specific approaches to surveillance that have been successful in other 
industries and should be replicated for HIT. We indicated that we 
expected to issue annual guidance for ONC-ACBs identifying ONC's 
priorities regarding certain elements of surveillance that could be 
considered for inclusion in their surveillance plans.
    We noted that we expected to use the results of ONC-ACB 
surveillance as feedback on the operations of the permanent 
certification program and to make information publicly available 
regarding the implementation and performance of Complete EHRs and EHR 
Modules in the field. We further noted that surveillance results could 
also be used by prospective purchasers of Complete EHRs and/or EHR 
Modules as a tool for evaluating specific products. We emphasized that 
surveillance results obtained by ONC-ACBs and reported to the National 
Coordinator would not immediately affect a Complete EHR or EHR Module's 
certification. We stated that, if after an ONC-ACB reevaluated a 
Complete EHR it had previously certified and reported that the Complete 
EHR no longer met a certification criterion or criteria because, for 
example, an individual had taken actions to alter a capability provided 
by the Complete EHR such that it no longer performed according to its 
original design or improperly installed the Complete EHR, such a result 
would not automatically invalidate the Complete EHR's certification. We 
also stated that we would expect ONC-ACBs upon the identification of a 
pattern of poorly performing previously certified Complete EHRs and/or 
EHR Modules to determine whether they had properly certified the 
Complete EHR or EHR Module in the past. Further, we requested public 
comment on whether the National Coordinator should consider taking 
proactive steps to protect purchasers of Complete EHRs and/or EHRs 
Modules through actions such as ``de-certifying'' Complete EHRs and/or 
EHR Modules if a pattern of unsatisfactory surveillance results emerges 
and the ONC-ACB has not taken any measures to evaluate the poor 
performance.
    Comments. We received many comments related to surveillance with 
commenters supporting the concept of surveillance as well as offering 
recommendations for the focus/elements of surveillance plans. An 
overarching theme expressed in the comments was that surveillance 
conducted by ONC-ACBs under the permanent certification program should 
have uniform and consistent elements. Commenters expressed various 
opinions about the focus/elements of surveillance plans. One commenter 
noted that Guide 65, Section 13 does not specifically identify post-
market surveillance of products that are being used by purchasers. This 
commenter also mentioned that Guide 65 is currently under review by ISO 
and requested clarification as to how the National Coordinator would 
address any changes to Guide 65. Another commenter expressed a concern 
that the term ``surveillance'' might be associated with FDA post-market 
activities of drugs and devices, which would suggest that surveillance 
involves the reporting of only adverse events. Therefore, the commenter 
suggested using the term ``monitoring'' to describe the surveillance 
process because the commenter asserted that ``monitoring'' better 
conveys the process of assessing the performance, and encouraging the 
adoption of, Certified EHR Technology. A commenter expressed concerns 
about surveillance from a practical perspective and gave the example 
that the surveillance of MRI or CT devices for radiation doses is of a 
different scope than overseeing the functionality of Certified EHR 
Technology. The commenter further asserted that, for clinical systems, 
it will be important that any type of surveillance activity to measure 
system safety not become overly prescriptive or stringent. Another 
commenter requested clarification of whether surveillance would be 
limited to the certified Complete EHR or EHR Module or extend to 
include the end user's use of the Complete EHR and EHR Module, 
including the assembly of certified EHR Modules into Certified EHR 
Technology.
    Multiple commenters asserted that surveillance should focus only on 
adopted certification criteria and whether certified products meet the 
criteria in operation. Consistent with this position, commenters 
suggested that surveillance plans should contain elements such as 
testing whether certified Complete EHRs and EHR Modules are performing 
in ``live'' environments as certified, ensuring that Complete EHR and 
EHR developers ``label'' certified Complete EHRs and EHR Modules 
according to their certifications, and monitoring that the versions of 
Complete EHRs and EHR Modules that are being used are certified 
versions. Some commenters suggested that surveillance could assess 
patient and/or provider satisfaction. More specifically, commenters 
suggested that surveillance could attempt to assess eligible 
professionals' and eligible hospitals' success in achieving meaningful 
use with the certified Complete EHRs and EHR Modules. However, many 
commenters recognized that surveillance of concepts such as 
satisfaction and success would implicate additional variables, such as 
training and implementation, as well as other factors such as 
subjective observations.
    Response. Our proposed approach to surveillance was based on the 
concept that eligible professionals and eligible hospitals must be able 
to rely on the certifications that are issued by ONC-ACBs. ONC-ACBs 
have a responsibility to ensure that the certifications they issue 
serve as an indication of a Complete EHR and/or EHR Module's 
capabilities and compliance with the certification criteria adopted by 
the Secretary. We expect ONC-ACBs, consistent with their accreditation 
and Guide 65, to conduct surveillance of the Complete EHRs and/or EHR 
Modules they have previously certified. An ONC-ACB would focus its 
surveillance activities on whether the Complete EHRs and/or EHR Modules 
it has certified continue to perform ``in the field'' or in a ``live'' 
environment as they did when they were certified. Many commenters 
understood this to be the scope of our proposal and agreed with this 
approach. Other commenters, however, suggested that we consider other 
aspects of performance that are less directly related to whether a 
previously certified Complete EHR or EHR Module continues to perform in 
a manner consistent with its certification (e.g., the assessment of a 
provider's success in achieving meaningful use). While we appreciate 
these additional suggestions, we do not believe that they are 
appropriate to include as requirements for ONC-ACBs in this final rule 
because they would not accomplish our stated objective for 
surveillance, namely, to confirm that previously certified Complete 
EHRs and EHR Modules continue to perform ``in the field'' or in a 
``live'' environment as they did when they were certified.
    We believe the term ``surveillance'' was readily understood by 
commenters

[[Page 1283]]

and is a more appropriate term to use than ``monitoring'' as suggested 
by a commenter. As discussed here and noted in the Proposed Rule, we 
anticipate surveillance will involve the assessment of whether 
certified Complete EHRs and EHR Modules are continuing to function as 
intended when they are in operational settings (i.e., ``in the field'' 
or in a ``live'' environment). We noted in the Proposed Rule that if a 
certified Complete EHR or EHR Module was not functioning in a manner 
consistent with its certification, we would expect the ONC-ACB to 
identify the reason(s) the Complete EHR or EHR Module was not 
functioning properly. We expect surveillance results will indicate the 
reason(s) behind a Complete EHR or EHR Module's failure to function 
properly, such as an implementation error, a misapplication by a user, 
or other factors.
    To further illustrate our expectations for surveillance, we offer 
the following examples based on the capabilities included in three 
certification criteria. When ONC-ACBs perform surveillance, we would 
expect them to verify that a certified Complete EHR or, if applicable, 
a certified EHR Module properly performs drug-drug, drug-allergy 
interaction checks in accordance with Sec.  170.302(a) in an 
operational setting. This could include, for example, the use of 
scenarios or test data to determine whether the certified Complete EHR 
or EHR Module correctly generates automatic notifications of 
contraindications. If the certified Complete EHR or EHR Module does not 
correctly generate automatic notifications, we would expect the ONC-ACB 
to identify the cause of this problem, to the extent that the ONC-ACB 
is reasonably able to do so. The ONC-ACB might find, for example, that 
the notifications were turned off by a user or technician, or that the 
Complete EHR or EHR Module was improperly installed. As a similar 
example using the capabilities required by Sec. Sec.  170.304(e)(2) and 
170.306(c)(2), a certified Complete EHR or, if applicable, a certified 
EHR Module must correctly generate (based on the clinical decision 
support rules it includes) an automatic notification when a scenario or 
test data would cause such a notification to be triggered. If the 
certified Complete EHR or EHR Module does not correctly generate an 
automatic notification, we would expect the ONC-ACB to identify and the 
surveillance results to reflect the reason(s) why this failed to occur. 
As a final example, we would expect an ONC-ACB performing surveillance 
to verify whether a certified Complete EHR or, if applicable, a 
certified EHR Module correctly generates patient reminder lists as 
required by Sec.  170.304(d). If patient reminder lists are not 
correctly generated in an operational setting, then as with the 
preceding examples, we would expect the ONC-ACB to determine why the 
patient reminder lists are not being correctly generated to the extent 
it is reasonably able to do so. We believe these examples should 
clarify for commenters the extent to which ONC-ACBs will be expected to 
assess as part of surveillance an end user's use of Certified EHR 
Technology and the ``assembly'' of Certified EHR Technology.
    We appreciate the broad range of responses and opinions from 
commenters who suggested possible areas or topics that surveillance 
could address. As we indicated in the Proposed Rule, we anticipate that 
we will issue guidance on an annual basis in order to identify specific 
elements of surveillance that we consider to be a priority. For 
example, the guidance could specify as a priority specific capabilities 
required by an adopted certification criterion (e.g., electronic 
prescribing) or categories of capabilities required by adopted 
certification criteria (e.g. ``safety-related'' capabilities, which 
could include computerized provider order entry (CPOE); clinical 
decision support (CDS); drug-drug, drug-allergy interaction checks; 
electronic prescribing; and other similar capabilities required by 
adopted certification criteria). The purpose of this guidance will be 
to assist ONC-ACBs as they develop their annual surveillance plans by 
providing them with information on topics that could be addressed in 
those plans. It will also convey information to other industry 
stakeholders, such as HIT developers and users, regarding ONC's 
priorities for surveillance. We presume that this guidance could 
include topics that would be consistent from year to year, but that it 
might also include specific focus areas in certain cases, such as when 
a new certification criterion has been adopted that we believe is 
important to assess. In developing any future guidance regarding 
surveillance, we will consider the comments received in the course of 
this rulemaking, and we expect that the input provided by commenters 
will prospectively inform our thinking on this topic.
    In response to our surveillance proposals, a commenter indicated 
that Guide 65 does not explicitly call for post-market surveillance. 
While the words ``post-market surveillance'' are not expressly included 
in Guide 65, we interpret Section 13.4 to include this concept when it 
states that certification bodies ``shall periodically evaluate the 
marked products to confirm that they continue to conform to the 
standards.'' With respect to the comment regarding potential revisions 
to Guide 65, if such revisions were to occur and be finalized, the 
National Coordinator would evaluate the revised version in the context 
of the permanent certification program and determine what action to 
take based on that evaluation.
    Comments. Commenters recommended that surveillance be consistent 
among ONC-ACBs and be conducted using reliable assessment measures that 
will produce valid and objective results. To ensure consistency, 
multiple commenters recommended a centralized approach to surveillance 
with one commenter recommending that the ONC-AA be responsible for 
ensuring a consistent approach to surveillance among the ONC-ACBs it 
accredits. Commenters suggested various methods for conducting 
surveillance, but generally agreed that the methods should meet 
scientific and industry best practices regarding sampling, statistical 
significance, independence and transparency of evaluation. One 
commenter suggested conducting surveys of Complete EHR and EHR Module 
purchasers. Another commenter recommended that surveillance be 
conducted through actual inspection and/or testing, rather than through 
a passive form of review. Some commenters contended that surveillance 
must be conducted at more than one individual site to ensure a 
statistically valid sample. To obtain a valid sample, commenters 
recommended using a representative sample, such as a percentage of a 
Complete EHR or EHR Module developer's customer base or an assessment 
based on no less than five customer sites. A few commenters suggested 
that intervals of surveillance be clearly specified.
    Response. Although we stated in the Proposed Rule that ONC-ACBs 
should have flexibility in developing their approaches to surveillance, 
we strongly agree with the commenters that there should be consistency 
among these surveillance approaches and that surveillance should be 
conducted through methods that meet scientific and industry best 
practices regarding sampling, statistical significance, independence 
and transparency of evaluation. To achieve a necessary degree of 
consistency, we believe and agree with the commenter who suggested that 
the ONC-AA should be responsible for ensuring that all of the 
certification bodies it accredits will use

[[Page 1284]]

similar and comparable surveillance approaches. Therefore, we are 
revising proposed paragraph (b)(2) of Sec.  170.503 to require an 
accreditation organization that seeks to become the ONC-AA to submit a 
detailed description of how its accreditation requirements will ensure 
that the surveillance approaches employed by ONC-ACBs will include the 
use of consistent, objective, valid, and reliable methods. We are also 
revising paragraph (e)(2) of Sec.  170.503 to state that an ONC-AA 
must, in accrediting certification bodies, not only verify conformance 
to, at minimum, Guide 65, but also ensure that the surveillance 
approaches across all of the certification bodies that it accredits 
include the use of consistent, objective, valid, and reliable methods. 
We believe that these parameters will still provide sufficient 
flexibility for ONC-ACBs to develop their surveillance plans and 
conduct surveillance, but also meet our programmatic goals and 
addresses concerns expressed by commenters, such as ensuring that the 
sampling mechanisms used by ONC-ACBs are appropriate and that one ONC-
ACB will not use appreciably more stringent surveillance methods than 
another ONC-ACB.
    Comments. A few commenters recommended that we should conduct and 
make publicly available a study and/or analysis to evaluate the options 
for surveillance, provide specific proposals for surveillance based on 
the results, and obtain feedback from stakeholders through a process of 
public notice and comment. Similarly, commenters asserted that if the 
National Coordinator intends to specify the elements of surveillance 
that will be required as part of ONC-ACBs' surveillance plans, then the 
public should have an opportunity to comment on the specific elements. 
A commenter requested that before ONC-ACBs are instructed to conduct 
surveillance, ONC should provide additional information and an 
opportunity for the industry to comment on ONC's positions, 
particularly with respect to various questions raised by the commenter. 
One commenter suggested that all ONC-ACB surveillance plans should be 
subject to review and public comment to allow input from technology 
vendors.
    Response. We do not believe it is necessary at this time to conduct 
a study or analysis of potential approaches to surveillance because, as 
explained above, we have provided an approach to surveillance that we 
believe is appropriate for the permanent certification program. We did 
not intend to imply as some commenters may have interpreted that there 
would be a formal opportunity for the public to comment on the 
surveillance plans that will be submitted by ONC-ACBs or ONC's 
recommendations on specific elements that could be addressed in those 
plans. In order to apply for ONC-ACB status, a certification body first 
must develop its surveillance approach in accordance with Guide 65 and 
then seek accreditation by the ONC-AA. The ONC-AA in turn will 
subsequently evaluate whether the certification body's proposed 
approach to surveillance is consistent with Guide 65 in general and 
more specifically with section 13 that addresses the concept of 
surveillance. As we explained in the Proposed Rule, Guide 65 
constitutes a minimum threshold that certification bodies will need to 
meet in order to become accredited, and as such, the ONC-AA could 
specify additional requirements for surveillance as part of its program 
to accredit certification bodies. With respect to the annual 
surveillance plans submitted to the National Coordinator, we expect 
that these plans will be based on and consistent with the requirements 
of an ONC-ACB's accreditation. As we mentioned in the Proposed Rule and 
further discussed above, we expect to issue annual guidance to ONC-ACBs 
to inform their understanding of topics or elements that may be 
addressed in the surveillance plans. As we develop that guidance, we 
will take into account the comments discussed above and may seek 
additional input from the public if necessary, such as through the HIT 
Policy Committee.
    Comments. Commenters suggested that surveillance should include the 
input of eligible professionals and eligible hospitals. These 
commenters suggested that efficient feedback could be achieved either 
through a feedback process incorporated into Certified EHR Technology 
or by requiring a ``label'' on Complete EHRs and EHR Modules that 
provides instructions for reporting complaints or concerns. One 
commenter suggested such a ``complaint process'' could be patterned 
after the Council for Affordable Quality Healthcare (CAQH's) Committee 
on Operating Rules for Information Exchange (CORE) policies and 
processes for documenting and correcting compliance violations. A 
commenter also stated that, to ensure objectivity and eliminate bias, 
Complete EHR and EHR Module developers should be prevented from 
influencing evaluations.
    Commenters suggested that the publication of surveillance results 
would be a beneficial tool for eligible professionals and eligible 
hospitals seeking to purchase Certified EHR Technology in an effort to 
qualify for incentive payments under the Medicare and Medicaid EHR 
Incentive Programs. Commenters expressed opinions, however, that 
Complete EHR and EHR Module developers should have an opportunity to 
respond to ``negative input'' before surveillance results are published 
and that surveillance results should not be used to influence specific 
purchasing decisions because this might implicate a conflict of 
interest in the role of an ONC-ACB.
    Response. In general, eligible professionals and eligible hospitals 
should have the opportunity to provide feedback through a complaints 
process established by Complete EHR and EHR Module developers. Guide 
65, Section 15 instructs an ONC-ACB to ensure that the developers of 
the HIT that it certifies have a process in place for receiving and 
addressing complaints related to certified products. Section 15 also 
requires that the HIT developers make complaint records available to 
the ONC-ACB upon request. We anticipate that eligible professionals and 
eligible hospitals may also have the opportunity to provide feedback 
about the capabilities of the Complete EHRs and EHR Modules that they 
possess in those cases where they are contacted by an ONC-ACB to 
participate in surveillance.
    Because an ONC-ACB's accreditation and credibility is at stake with 
respect to the certifications it issues, we believe it will take the 
proper steps to prevent EHR technology developers from inappropriately 
influencing the outcomes of surveillance. However, we also expect that 
through the procedures developed by ONC-ACBs for performing 
surveillance, Complete EHR and EHR Module developers will be provided 
an opportunity to give input to an ONC-ACB, where appropriate, 
regarding the surveillance results obtained by the ONC-ACB prior to it 
reporting such results to the National Coordinator. Therefore, we do 
not expect it will be necessary to provide for any additional 
opportunity for input from Complete EHR and EHR Module developers after 
surveillance results have been submitted by an ONC-ACB to the National 
Coordinator. Lastly, although we indicated in the Proposed Rule that we 
expected to make the surveillance results that we receive from ONC-ACBs 
publicly available, we have not yet determined whether or in what form 
these results will be made available.
    Comments. We received comments both supporting and opposing the 
option for the National Coordinator to take proactive steps to protect 
purchasers of certified technology (for

[[Page 1285]]

example, by ``decertifying'' the technology) if a pattern of 
unsatisfactory surveillance results emerges and an ONC-ACB has not 
taken any measures to evaluate the poor performance. Commenters 
expressed support for the idea of ``decertification'' if a pattern of 
unsatisfactory surveillance results emerged because it is important to 
protect purchasers of Complete EHRs and/or EHRs Modules. Alternatively, 
a commenter suggested that if the ONC-ACB in question does not take any 
measures to evaluate the poor performance of a certified Complete EHR 
or EHR Module, then the National Coordinator should have another ONC-
ACB conduct the evaluation or the National Coordinator should conduct 
the evaluation before proceeding with decertification. Some commenters 
stated that any form of decertification should be left to the 
discretion of the ONC-ACBs. Other commenters asked us to explain how a 
decertification process would be conducted and to provide an 
opportunity for the public to comment on the process. Multiple 
commenters recommended that we should consider the impact 
decertification would have on eligible professionals and eligible 
hospitals that are using the affected certified Complete EHR or EHR 
Module to meet the requirements of the Medicare and Medicaid EHR 
Incentive Programs.
    Response. We appreciate the thoughtful comments that were submitted 
on this matter, although we will not use this final rule to establish a 
process for the decertification of Complete EHRs and/or EHR Modules. 
After ONC-ACBs begin to conduct surveillance and submit the results to 
the National Coordinator, we will have an opportunity to assess the 
results and determine whether ONC-ACBs are taking appropriate action to 
address any patterns of unsatisfactory results. If we determine that 
unsatisfactory surveillance results are not being addressed, or if the 
results indicate certified Complete EHRs or EHR Modules are adversely 
affecting public health or safety or the programmatic goals of the 
permanent certification program, we will consider what steps are 
necessary to respond to the particular situation at issue at that time. 
In taking any action, commenters can be assured that the National 
Coordinator will consider the impact on eligible professionals and 
eligible hospitals who are using certified products to meet the 
requirements of the Medicare and Medicaid EHR Incentive Programs. We 
believe the potential consequences of failing to fulfill their 
responsibilities, such as facing corrective action under the permanent 
certification program or losing reputational standing and business in 
the market, will sufficiently motivate the ONC-AA and the ONC-ACBs to 
take the necessary actions to ensure surveillance plans are followed 
and unsatisfactory surveillance results are properly addressed. We also 
believe that the potential for surveillance results to be made publicly 
available as we proposed will sufficiently motivate developers of 
Complete EHRs and/or EHR Modules to improve their products and address 
any shortcomings identified by the ONC-ACB surveillance process.
g. Refunds
    We proposed in Sec.  170.523(j) to require an ONC-ACB to promptly 
refund any and all fees received for certifications that will not be 
completed.
    Comments. Commenters requested that we clarify that refunds would 
only be required where an ONC-ACB's conduct caused the certification to 
be incomplete as opposed to the failure of a developer of Complete 
EHRs, EHR Modules and/or other types of HIT to meet certification 
requirements. One commenter contended that this provision should only 
apply when an ONC-ACB has its accreditation status revoked. Another 
commenter suggested that our proposed requirement for ONC-ACBs to 
return funds should also apply to situations where developers are 
required to recertify their products because of misconduct by an ONC-
ACB.
    Response. We agree with the commenters that suggested our proposed 
refund requirement needs clarification. As advocated by the commenters 
and as clarified for ONC-ATCBs in the Temporary Certification Program 
final rule, it was our intention to require ONC-ACBs to issue refunds 
only in situations where an ONC-ACB's conduct caused certification to 
not be completed. We also agree with the one commenter that this would 
include situations where a Complete EHR and/or EHR Module is required 
to be recertified because of the conduct of an ONC-ACB. Similarly, if 
an ONC-ACB were to be suspended by the National Coordinator under the 
suspension provisions we have incorporated in this final rule, an ONC-
ACB would be required to refund all fees paid for certification if a 
Complete EHR or EHR Module developer withdraws a request for 
certification while the ONC-ACB is under suspension.
    We are revising Sec.  170.523(j) consistent with our discussion 
above.
h. Suggested New Principles of Proper Conduct
    We received a few comments that suggested we should adopt 
additional principles of proper conduct. These comments concerned the 
impartiality and business practices of ONC-ACBs.
    Comments. A commenter recommended that applicants for ONC-ACB 
status should be required not to have an interest, stake and/or 
conflict of interest in more than one entity receiving ONC-ACB status 
nor have any conflict of interest with EHR product companies actively 
promoting EHR products in the marketplace. Another commenter 
recommended that we adopt a principle of proper conduct that requires 
an ONC-ACB to establish, publish and adhere to a non-discriminatory 
protocol to ensure that requests for certification are processed in a 
timely manner beginning on the date the ONC-ACB sets for accepting 
requests for certification. One commenter recommended that all requests 
for certification be required to be processed within 6 months of 
receipt by an ONC-ACB.
    Response. Applicants for ONC-ACB status and ONC-ACBs must be 
accredited, which requires adherence to the requirements of Guide 65 at 
a minimum. These requirements explicitly obligate certification bodies 
to conduct business in an impartial manner. For instance, an applicant 
for ONC-ACB status and/or an ONC-ACB must have a documented structure 
which safeguards impartiality, including provisions to ensure the 
impartiality of the operations of the certification body and that 
activities of related bodies do not affect the confidentiality, 
objectivity and impartiality of its certifications. Guide 65 also 
specifically states that ``access shall not be conditional upon the 
size of the [Complete EHR or EHR Module developer] or membership [in] 
any association or group, nor shall certification be conditional upon 
the number of certificates already issued.'' We believe these 
provisions as well as other impartiality provisions contained in Guide 
65 will adequately address any potential conflicts of interest, 
potential discriminatory practices, or other situations that might 
jeopardize the integrity of the permanent certification program. We 
will not require requests for certification to be completed within six 
months as the commenter proposed. A predetermined timeframe is not 
realistic because the time it takes for a product to be certified will 
likely vary based on factors such as the current number of ONC-ACBs, 
the volume of

[[Page 1286]]

requests for certification, the type of product that is submitted for 
certification, and an ONC-ACB's specific business practices.
3. Application Submission
    We proposed in Sec.  170.525 to allow an applicant for ONC-ACB 
status to submit its application either electronically via e-mail (or 
web submission if available), or by regular or express mail at any time 
during the existence of the permanent certification program. We did not 
receive any comments on this proposal. We are, however, revising Sec.  
170.525 to clarify that an applicant for ONC-ACB status may submit its 
application at any time after the permanent certification program has 
been established by this final rule.
4. Overall Application Process
    We received a few comments regarding the overall application 
process.
    Comment. One commenter contended that there is an optimal number of 
ONC-ACBs that can effectively perform certification in both the near 
and long term. The commenter reasoned that if there are too few ONC-
ACBs, then the ONC-ACBs will be unable to handle the demand for 
certifications that can be expected at the outset of the permanent 
certification program. Alternatively, the commenter reasoned that if 
there are too many ACBs, the demand for their services may not be 
sufficient for all of them to remain financially viable. The commenter 
believed the key to the appropriate number of ONC-ACBs is for ONC to 
determine the ONC-ACBs' ability to handle the needs of the market. 
Another commenter suggested that the number of ONC-ACBs be limited to 
5. The commenter reasoned that there might be variances in 
certification processes if there are too many ONC-ACBs, while limiting 
the number of ONC-ACBs to 5 organizations will ensure that an ONC-AA 
will be able to effectively monitor the ONC-ACBs. One commenter 
suggested that applicants for ONC-ACB status preferably be not-for-
profit organizations.
    Response. We believe it is appropriate to allow all qualified 
applicants to apply and obtain ONC-ACB status and that organizations 
will determine whether pursuing ONC-ACB status can be a successful 
business venture. We believe that a greater number of successful 
applicants for ONC-ACB status will benefit the market in terms of 
increased competition and more options for the certification of 
Complete EHRs, EHR Modules, and/or other types of HIT. Restricting the 
number of ONC-ACBs or imposing arbitrary eligibility requirements on 
applicants, such as requiring an applicant to be a not-for-profit 
organization, will only limit these potential benefits. Further, we 
believe that the requirements of the permanent certification program, 
including requiring accreditation from a sole ONC-AA and adherence to 
the Principles of Proper Conduct for ONC-ACBs, will ensure the 
necessary consistency in certifications granted by ONC-ACBs.
    Comments. A commenter recommended that we provide for ``provisional 
acceptance'' of an organization before requiring an organization to go 
through full accreditation to become an ONC-ACB. The commenter believed 
this would lessen the risk for organizations in pursuing ONC-ACB 
status.
    Response. Based on the structure of the permanent certification 
program and the important role played by the ONC-AA, we do not believe 
that we could properly evaluate the qualifications of an organization 
until after it had obtained the appropriate accreditation. Therefore, 
we do not believe we could offer any form of ``provisional acceptance'' 
without fundamentally altering the permanent certification program's 
structure.

H. ONC-ACB Application Review, Reconsideration, and ONC-ACB Status

    In the Proposed Rule, we proposed to review an application for ONC-
ACB status and issue a decision within 30 days in most cases. We 
proposed that if an applicant was issued a denial notice and certain 
criteria were met, an applicant could seek reconsideration of the 
denied application. We proposed that if an applicant's application were 
deemed satisfactory, we would make it publicly known that the applicant 
had achieved ONC-ACB status and that the ONC-ACB would be able to begin 
certifying consistent with the authorization granted by the National 
Coordinator. We further proposed that an ONC-ACB's status would expire 
two years from the date it was granted unless it was renewed.
1. Application Review
    We proposed in Sec.  170.530 that we would review completed 
applications in the order in which we received them and that the 
National Coordinator would issue a decision within 30 days of receipt 
of an application submitted for the first time.
    We proposed that the National Coordinator would be able to request 
clarification of statements and the correction of inadvertent errors or 
minor omissions. In these cases, before issuing a formal deficiency 
notice, we proposed that the National Coordinator may request such 
information from the applicant's authorized representative as an 
addendum to its application. We further proposed that if the applicant 
failed to provide such information to the National Coordinator within 
the timeframe specified, which would not be less than 5 days, the 
National Coordinator could issue a formal deficiency notice. In other 
circumstances, the National Coordinator could immediately send a formal 
deficiency notice if it was determined that significant deficiencies 
existed which could not be addressed by a clarification or correction 
of a minor omission.
    We proposed that the National Coordinator would identify any 
deficiencies in an application and provide an applicant with an 
opportunity to correct any deficiencies by submitting a revised 
application in response to a deficiency notice. We proposed that an 
applicant would have 15 days to submit a revised application in 
response to a deficiency notice and that the National Coordinator would 
be permitted up to 15 days to review a revised application once it has 
been received. We further proposed that if the National Coordinator 
determined that a revised application still contained deficiencies, the 
applicant would be issued a denial notice indicating that the applicant 
would no longer be considered for authorization under the permanent 
certification program.
    We proposed that an applicant could request reconsideration of the 
decision in accordance with Sec.  170.535. We proposed that an 
application would be deemed satisfactory if it met all of the 
application requirements. We further proposed that once the applicant 
was notified of this determination, the applicant would be able to 
represent itself as an ONC-ACB and begin certifying Complete EHRs, EHR 
Modules and/or other types of HIT consistent with its authorization.
    Comments. We did not receive any comments specific to Sec.  
170.530. We did, however, receive two comments on the temporary 
certification program application review provisions during the 
permanent certification program public comment period that are equally 
applicable to Sec.  170.530. A commenter expressed agreement and 
support for the proposed process affording the National Coordinator 
discretion to request clarifications of statements or corrections of 
errors or omissions, but the commenter did not agree that such requests 
should be limited to only

[[Page 1287]]

inadvertent or minor errors. The commenter reasoned that given the time 
constraints and complexity of the application process, the National 
Coordinator should be able to consider requesting clarifications or 
corrections in a collaborative process with applicants, as appropriate. 
The commenter also expressed general agreement with our proposal that 
an applicant be provided up to 15 days to respond to a formal 
deficiency notice. The commenter suggested, however, that considering 
our position that not many organizations will be capable of obtaining 
authorization under the certification programs, the National 
Coordinator should have the discretion to grant an extension beyond the 
15-day response period upon a showing of good cause by the applicant.
    Response. Based on the comments received, we believe that certain 
modifications to the ONC-ACB application review process would be 
beneficial for ONC-ACB applicants as well as the permanent 
certification program as a whole. We made similar modifications to the 
ONC-ATCB application review process in the Temporary Certification 
Program final rule.
    We agree with the commenter that the process for the National 
Coordinator to seek corrections of errors and omissions should be 
revised. Therefore, as recommended by the commenter, we are removing 
the words ``inadvertent'' and ``minor'' from Sec.  170.530(b)(1). 
Although we anticipate that the National Coordinator would likely seek 
correction of only minor errors or omissions (e.g., missing contact 
information of an authorized representative as opposed to a more 
significant deficiency such as not providing sufficient documentation 
that confirms that the applicant has been accredited by the ONC-AA), 
these revisions will provide the National Coordinator with more 
flexibility to allow an applicant to correct an error or omission 
instead of issuing a deficiency notice to the applicant. This 
flexibility will be beneficial for applicants and the permanent 
certification program itself considering the limited opportunities and 
short timeframes for correcting applications. Similarly, we believe 
that the application review process would be improved if the National 
Coordinator could also request the clarification of statements and the 
correction of errors or omissions in a revised application. This change 
will make the application review process more collaborative as 
suggested by the commenter. Therefore, we are also revising Sec.  
170.530 to allow the National Coordinator to request clarification of 
statements and the correction of errors or omissions during the 15-day 
period provided for review of a revised application.
    We are making additional revisions to Sec.  170.530 in response to 
the commenter's recommendation that the National Coordinator should 
have the discretion, upon a showing of good cause by the applicant, to 
grant an extension beyond 15 days for an applicant to submit a revised 
application in response to a deficiency notice. We agree with the 
commenter's recommendation and are revising Sec.  170.530 to allow an 
applicant for ONC-ACB status to request an extension of the 15-day 
period for submitting a revised application in response to a deficiency 
notice and to provide the National Coordinator with the option of 
granting an applicant's request for additional time to respond to a 
deficiency notice upon a showing of good cause by the applicant. In 
determining whether good cause exists, the National Coordinator will 
consider factors such as: change in ownership or control of the 
applicant organization; the unexpected loss of a key member of the 
applicant's personnel; damage to or loss of use of the applicant's 
facilities, working environment or other resources; or other relevant 
factors that would prevent the applicant from submitting a timely 
response to a deficiency notice.
    We believe it is unnecessary to establish a predetermined period of 
time for a good cause extension. Instead, the duration of an extension 
will be determined based on an applicant's particular circumstances 
that constitute good cause for the extension. For example, if an 
applicant is accredited but fails to submit sufficient documentation of 
its accreditation, a good cause extension could be granted for a period 
of time that would allow the applicant to obtain and submit the 
appropriate documentation.
    We proposed in Sec.  170.530(c)(4) that if the National Coordinator 
determines that a revised application still contains deficiencies, the 
applicant will be issued a denial notice indicating that the applicant 
will no longer be considered for authorization under the permanent 
certification program. We believe this section should be modified in 
order to allow unsuccessful applicants to reapply for ONC-ACB status 
after a period of time has passed. Although we proposed in Sec.  
170.535 that applicants could submit a request for the National 
Coordinator to reconsider a denial notice, this reconsideration process 
is only applicable to an application that is the subject of a denial 
notice and only in limited circumstances. We believe revisions to Sec.  
170.530(c)(4) are necessary because, as discussed below, it could 
significantly compromise the quality of the permanent certification 
program if qualified applicants are unable to reapply for ONC-ACB 
status because they were previously issued a denial notice. 
Consequently, we are revising this section to state that a denial 
notice will indicate that the applicant cannot reapply for ONC-ACB 
status for a period of six months from the date of the denial notice.
    As proposed, Sec.  170.530(c)(4) would prevent applicants from 
reapplying and being considered for ONC-ACB status if they have been 
issued a denial notice for the permanent certification program. Once a 
denial notice has been issued, the unsuccessful applicant would be 
permanently barred from submitting any subsequent applications for ONC-
ACB status. We believe that a permanent bar on reapplying for ONC-ACB 
status could potentially have detrimental effects on the permanent 
certification program. Unlike the temporary certification program, the 
permanent certification program has no anticipated sunset date and is 
expected to continue indefinitely. We believe an applicant for ONC-ACB 
status that receives a denial notice should be given an opportunity to 
correct the deficiency or deficiencies on which the denial notice was 
based. For example, an applicant that is otherwise qualified to serve 
as an ONC-ACB could be issued a denial notice if its accreditation is 
suspended or revoked while its ONC-ACB application is under review. The 
application review process finalized in this rule is intended to 
provide applicants with multiple opportunities to correct problems with 
their applications. We recognize, however, that an applicant may need 
more time to have its accreditation reinstated than would be possible 
within the timeframe for application review, even if the applicant 
could show good cause for an extension. We believe it would be unfair 
and contrary to the program's best interests not to allow such an 
applicant to reapply for ONC-ACB status. As another example, an 
otherwise qualified applicant may be barred from reapplying if it 
receives a denial notice because it unintentionally missed an 
established deadline for responding to a deficiency notice and did not 
request a good cause extension for submitting a revised application. As 
previously noted, we expect that only a limited number of organizations 
will possess the requisite qualifications that would enable them to 
become ONC-

[[Page 1288]]

ACBs. Permanently barring qualified applicants from reapplying solely 
because they had been issued a denial notice would unnecessarily 
restrict the limited supply of organizations that are qualified to 
serve as ONC-ACBs. We believe such a restriction would not be in the 
best interest of the permanent certification program and would 
undermine our objective to encourage a competitive market for the 
certification of HIT. Moreover, an applicant that is denied 
authorization to certify Complete EHRs and/or EHR Modules may still be 
qualified to certify other types of HIT. We believe such organizations 
should be given a chance to apply for ONC-ACB status in the event that 
other types of HIT are included in the permanent certification program 
after the Secretary adopts applicable certification criteria.
    We believe that 6 months is a reasonable period of time for an 
applicant to wait before it may reapply. By way of comparison, an 
organization that has had its ONC-ACB status revoked for a Type-1 
violation must wait 1 year in accordance with Sec.  170.565(h)(3) 
before it may reapply for ONC-ACB status. It would be inequitable as 
well as inconsistent with our program goals to permanently bar an 
organization from reapplying because it received a denial notice, while 
allowing an organization that had its ONC-ACB status revoked to reapply 
after a year. In light of the fact that Type-1 violations include 
violations of law or permanent certification program policies that 
threaten or significantly undermine the integrity of the permanent 
certification program, we believe that an organization's inability to 
meet the application requirements of Sec.  170.520 deserves a far 
lesser consequence than a permanent bar on reapplying for ONC-ACB 
status. We believe that a 6-month waiting period will in many cases 
provide sufficient time for an applicant to evaluate and correct the 
deficiencies with its application (assuming the deficiencies are 
capable of correction) and will deter unqualified applicants from 
repeatedly applying. Accordingly, we are revising paragraph (c)(4) of 
Sec.  170.530 consistent with the preceding discussion.
    We proposed an identical provision in Sec.  170.430(c)(4) for the 
temporary certification program, which we finalized in the Temporary 
Certification Program final rule. Under that provision, an applicant 
that is issued a denial notice cannot reapply and be considered for 
ONC-ATCB status, which we believe is appropriate for the temporary 
certification program. We anticipate that the temporary certification 
program will only remain in existence for a short period of time and 
expect that it will sunset on December 31, 2011. We expect that a vast 
majority of certifications will be conducted early in the temporary 
certification program based on the associated meaningful use 
requirements and reporting periods of the Medicare and Medicaid EHR 
Incentive Programs. Further, any applicant that is permanently barred 
from reapplying for ONC-ATCB status will still be able to apply for 
ONC-ACB status under the permanent certification program. Therefore, 
due to the short duration of the temporary certification program and 
the fact that an unsuccessful applicant for ONC-ATCB status may apply 
for ONC-ACB status under the permanent certification program, the 
consequences of a permanent bar on reapplication are not nearly as 
severe as they would have been under the permanent certification 
program had we not revised our proposal.
    We state in Sec.  170.530(d) that the National Coordinator will 
notify the applicant's authorized representative of its satisfactory 
application and its successful achievement of ONC-ACB status and that 
once notified, the applicant may represent itself as an ONC-ACB and 
begin certifying HIT consistent with its authorization. We believe it 
is important to clarify that there is a distinction between the point 
at which an organization is notified that it has been granted ONC-ACB 
status and the point when it may begin to perform certifications 
consistent with the authorization that it has been granted. To 
illustrate this distinction with an example, an applicant may be 
notified in October 2011 that it has been granted ONC-ACB status, 
although the permanent certification program is not scheduled to begin 
until at least January 1, 2012. After receiving notice, the ONC-ACB may 
begin to represent and market itself as ONC-ACB and participate in 
mandatory ONC training for ONC-ACBs, but its authorization to perform 
certifications would not become effective until the commencement of the 
permanent certification program on January 1, 2012 or on a subsequent 
date when the National Coordinator determines that the permanent 
certification program is fully constituted. At that time, the ONC-ACB 
may begin to certify the type(s) of HIT that fall within the scope of 
its authorization. Similarly, after the ONC-ACB has participated in the 
permanent certification program for a period of time, it may choose to 
submit a request to the National Coordinator to expand the current 
scope of its authorization (for example, to include other types of EHR 
Modules or Complete EHRs). If the National Coordinator grants its 
request based on the information it submits and the completion of any 
applicable mandatory ONC training, then the ONC-ACB's authorization 
would be expanded effective as of the date specified by the National 
Coordinator. In both cases (the initial granting of ONC-ACB status and 
the subsequent expansion of the ONC-ACB's authorization), the National 
Coordinator would make publicly available the date of the ONC-ACB's 
authorization and the type(s) of certification included within its 
authorization, pursuant to Sec.  170.540(a).
2. Application Reconsideration
    We proposed in Sec.  170.535 that an applicant after receiving a 
denial notice may request that the National Coordinator reconsider the 
denied application only if the applicant can demonstrate that clear, 
factual errors were made in the review of the application and that 
their correction could lead to the applicant obtaining ONC-ACB status. 
We proposed that an applicant would be required to submit, within 15 
days of receipt of a denial notice, a written statement to the National 
Coordinator contesting the decision to deny its request for ONC-ACB 
status and explaining with sufficient documentation what factual errors 
it believes can account for the denial. We proposed that if the 
National Coordinator did not receive the applicant's submission within 
the specified timeframe that its request could be rejected. We proposed 
that the National Coordinator would have up to 15 days to consider and 
issue a decision on a timely reconsideration request. We further 
proposed that if, after reviewing an applicant's reconsideration 
request, the National Coordinator determined that the applicant did not 
identify any factual errors or that correction of those factual errors 
would not remove all identified deficiencies in the application, the 
National Coordinator could reject the applicant's reconsideration 
request and that this decision would be final and not subject to 
further review.
    Comments. A commenter expressed agreement with our proposed ONC-ACB 
application reconsideration process. Another commenter stated, however, 
that the National Coordinator should have discretion to reconsider an 
application for reasons besides clear factual errors that could lead to 
the applicant receiving ONC-ACB status. The commenter suggested that 
the National Coordinator should consider

[[Page 1289]]

several factors in determining whether to reconsider an application, 
including the severity and type of the deficiency, the implications of 
the deficiencies, the applicant's level of responsiveness and 
cooperation, and the remedial efforts taken by the applicant.
    Response. We appreciate the one commenter's expression of support 
for our proposals. We do not agree with the commenter that the National 
Coordinator should reconsider all applications for any reason. Rather, 
as we determined for the temporary certification program in the 
Temporary Certification Program final rule, we believe that the 
National Coordinator should only reconsider an application if the 
applicant for ONC-ACB status can demonstrate that there were clear 
factual errors in the review of its application that could lead to the 
applicant obtaining ONC-ACB status. We believe that the application 
requirements and application review processes that we have proposed 
ensure that only qualified applicants are timely authorized to be ONC-
ACBs. The application requirements proposed, particularly the 
requirement that an applicant be accredited by an ONC-AA, are designed 
to ensure that applicants are qualified. Our review process is designed 
to ensure the veracity of an application and to confirm that an 
applicant has the necessary capabilities to be authorized to conduct 
the certification sought by the applicant. Our review process is also 
designed to reach final decisions in a timely manner. Overall, we 
believe the application review process is efficient yet fair by 
providing opportunities for the National Coordinator to request 
clarifications and corrections to the application, opportunities for an 
applicant to respond to a deficiency notice, and opportunities to 
request reconsideration of a denial notice if there are clear, factual 
errors that, if corrected, could lead to the applicant obtaining ONC-
ACB status. We also note that if an applicant is unable to demonstrate 
that clear, factual errors were made in the review of its application, 
it still would have the ability to reapply for ONC-ACB status after 
waiting a period of six months. Accordingly, we are finalizing Sec.  
170.535 without modification.
3. ONC-ACB Status
    We proposed in Sec.  170.540 that the National Coordinator will 
acknowledge and make publicly available the names of ONC-ACBs, 
including the date each was authorized and the type(s) of certification 
each has been authorized to perform. We proposed that each ONC-ACB 
would be required to prominently and unambiguously identify on its Web 
site and in all marketing and communications statements (written and 
oral) the scope of its authorization. We also proposed that an ONC-
ACB's status would expire two years from the date it was granted by the 
National Coordinator unless it was renewed. To renew its status, we 
proposed that an ONC-ACB submit a renewal request (i.e., an updated 
application) to the National Coordinator 60 days prior to the 
expiration of its status.
    In association with these proposals, we specifically requested that 
the public comment on whether there was any additional information an 
ONC-ACB should provide the National Coordinator in order to have its 
status renewed, such as documentation of the ONC-ACB's current 
accreditation status and any additional information or updates to the 
original application that would aid in the National Coordinator's 
review of the renewal request.
    Comments. A commenter expressed an opinion that it is important to 
the industry that the National Coordinator makes distinctions as to 
what a certifying body is authorized to certify. One commenter 
recommended that our requirements related to marketing and 
communications be limited to the ONC-ACB's Web site and all marketing 
and communications pertaining to its role in the certification of 
Complete EHRs, EHR Modules and/or other types of HIT under the 
permanent certification program. As currently written, the commenter 
contended that the requirements apply to all marketing and 
communications made by the entity even if unrelated to their ONC-ACB 
status.
    Commenters expressed agreement with having an ONC-ACB's status 
expire after two years, while others suggested 3-year and 4-year terms. 
The commenters requesting longer terms stated that a longer term would 
promote more stability and lessen overhead costs for ONC-ACBs. A 
commenter that suggested a 3-year term reasoned that a 3-year term 
could run concurrent with the ONC-AA's term. The commenter also 
requested that in cases where the ONC-AA has its status revoked or not 
renewed, ONC-ACBs should be allowed to retain their status with ONC 
until at least 12 months after a new ONC-AA has been appointed by ONC. 
The commenter reasoned that this would allow time for 
``reaccreditation'' by the approved accreditation organization.
    In terms of what information we should consider for the renewal of 
an ONC-ACB's status, commenters generally agreed that an ONC-ACB should 
provide updated accreditation information and demonstrate compliance 
with the Principles of Proper Conduct for ONC-ACBs. Commenters also 
suggested that ONC request and consider Complete EHR and EHR Module 
developers' evaluations of ONC-ACBs' performance, documentation 
regarding the handling of customer complaints by ONC-ACBs, the 
percentage of certifications in relation to requests for certification, 
the total number of previous certifications granted, the number of 
certifications granted after two or more attempts, and surveillance 
results.
    Response. We appreciate the support for our proposals and reiterate 
that, as proposed, an ONC-ACB will only be able to certify Complete 
EHRs, EHR Modules and/or other types of HIT consistent with the scope 
of authorization granted by the National Coordinator. Additionally, as 
proposed, the ONC-ACB will have to prominently and unambiguously 
display the scope of authorization granted to it by the National 
Coordinator. To address the commenter's concern about the overreach of 
our proposed requirement that an ONC-ACB ``identify on its Web site and 
in all marketing and communications statements (written and oral) the 
scope of its authorization'' we have clarified the language to clearly 
state that the requirement only applies to activities conducted by the 
ONC-ACB under the permanent certification program. Specifically, we 
have revised the provision to state, in relevant part, ``each ONC-ACB 
must prominently and unambiguously identify the scope of its 
authorization on its Web site, and in all marketing and communications 
statements (written and oral) pertaining to its activities under the 
permanent certification program.''
    We believe, after consideration of public comments, that an ONC-ACB 
should be allowed to maintain its status for three years, instead of 
the proposed two years, from the date it is granted before being 
required to renew its status. Considering that an applicant could 
obtain ONC-ACB status at any time during the permanent certification 
program, it would be impossible to align the tenure of the ONC-AA with 
that of the ONC-ACBs. However, a three-year term for ONC-ACBs will 
offer additional stability for those HIT developers seeking 
certification under the permanent certification program as well as for 
ONC-ACBs. It will also lessen the reapplication burden for ONC-ACBs. We 
anticipate by beginning the process to approve an ONC-AA at least 180 
days prior to the end of the then-current ONC-AA's term, there will

[[Page 1290]]

be minimal disruption in the accreditation processes if we were to 
select a different ONC-AA. As previously noted in this final rule, we 
intend to issue an NPRM that will address improper conduct by an ONC-AA 
and propose a corrective action process. At that time, we will consider 
the implications for ONC-ACBs if an ONC-AA's status is revoked or other 
corrective action is taken.
    We do not believe that there is a need to require an ONC-ACB to 
provide any of the information suggested by the commenters for ONC to 
consider in determining whether to renew an ONC-ACB's status. The 
Principles of Proper Conduct for ONC-ACBs require an ONC-ACB to submit 
a weekly list of certified Complete EHRs, EHR Modules, and/or other 
types of HIT, attend mandatory training, and submit an annual 
surveillance plan and annually report surveillance results. 
Accreditation requires an ONC-ACB to be compliant with Guide 65 at a 
minimum, which requires an ONC-ACB to have a complaints process that 
includes documentation of the resolution of complaints. Accreditation 
also involves a regular review of an ONC-ACB's processes and 
performance. Consequently, we believe that by maintaining its 
accreditation and adhering to the Principles of Proper Conduct for ONC-
ACBs, an ONC-ACB will be more than adequately situated to pursue 
renewal.
    To renew its status, an ONC-ACB must submit to the National 
Coordinator the information specified in Sec.  170.520(a) and (c) that 
would otherwise be required to apply for ONC-ACB status and, if 
applicable, include any requests to expand the current scope of its 
authorization. We expect that an ONC-ACB will be providing updates to 
the information specified in Sec.  170.520(b) as part of its compliance 
with the Principles of Proper Conduct for ONC-ACBs. Therefore, we do 
not expect an ONC-ACB to submit its ``general identifying information'' 
unless the information that is on record with ONC is outdated or 
otherwise incorrect. Lastly, we do not believe it will be necessary for 
an ONC-ACB to execute and submit a new agreement to adhere to the 
Principles of Proper Conduct for ONC-ACBs because the initial agreement 
that was executed when the organization obtained ONC-ACB status will 
remain valid as long as the organization maintains its ONC-ACB status.
    We are revising Sec.  170.540 consistent with this discussion, 
including clarifying the representation requirements of ONC-ACBs, 
extending the term of ONC-ACB status to 3 years and clarifying that a 
renewal request must include any updates to the information specified 
in Sec.  170.520.

I. Certification of Complete EHRs, EHR Modules and Other Types of HIT

    In the Proposed Rule, we described the scope of authority that 
would be granted to certification bodies that become ONC-ACBs. We also 
specified which certification criterion or criteria ONC-ACBs would be 
required to use to certify Complete EHRs, EHR Modules and/or other 
types of HIT. As discussed below, the comments we received on these 
proposed provisions were in many cases also applicable to analogous 
provisions of the temporary certification program. As a result of the 
similarities that exist between the temporary and permanent 
certification programs, our responses to the comments below are often 
similar or identical to responses we provided in the Temporary 
Certification Program final rule.
1. Complete EHRs
    We proposed in Sec.  170.545 that to be authorized to certify 
Complete EHRs under the permanent certification program, an ONC-ACB 
would need to be capable of certifying Complete EHRs to all applicable 
certification criteria adopted by the Secretary at subpart C of part 
170. We further proposed that an ONC-ACB that had been authorized to 
certify Complete EHRs would also be authorized to certify all EHR 
Modules under the permanent certification program.
    Comments. Commenters expressed agreement with our proposals that, 
in order to be authorized to certify Complete EHRs under the permanent 
certification program, an ONC-ACB must be capable of certifying 
Complete EHRs to all applicable certification criteria and that such an 
ONC-ACB would also be authorized to certify all EHR Modules under the 
permanent certification program. One commenter recommended that we 
require ONC-ACBs authorized to certify Complete EHRs to also certify 
EHR Modules.
    Response. We appreciate the commenters' support for our proposals, 
but we do not adopt the one commenter's recommendation that we require 
an ONC-ACB that is authorized to certify Complete EHRs to also certify 
EHR Modules. We clearly acknowledged in the preamble of the Proposed 
Rule and in our proposed regulatory provision that an ONC-ACB 
authorized to certify Complete EHRs would also have the capability and, 
more importantly, the authorization from the National Coordinator to 
certify EHR Modules. We do not, however, believe that we should require 
an ONC-ACB that is authorized to certify Complete EHRs to also certify 
EHR Modules. An ONC-ACB, despite its authorization to do so, might have 
multiple business justifications for choosing not to certify EHR 
Modules, such as an insufficient number of qualified employees to 
conduct the certification of EHR Modules in addition to conducting 
certification of Complete EHRs, or that doing both would not be as 
profitable a business model.
    Based on consideration of the comments received and review of the 
proposed provision, we are revising Sec.  170.545(a) to state that 
``When certifying Complete EHRs, an ONC-ACB must certify Complete EHRs 
in accordance with all applicable certification criteria adopted by the 
Secretary at subpart C of this part.'' This revision is consistent with 
our description of certification of Complete EHRs in the Proposed Rule 
preamble, as well as the approach we finalized for the temporary 
certification program. It also makes explicit that ONC-ACBs must not 
only be capable, but as with EHR Modules, are required to certify 
Complete EHRs to all of the applicable certification criteria adopted 
by the Secretary under subpart C of part 170. We are also redesignating 
proposed paragraph (b) as paragraph (e) because of additional revisions 
we are making to Sec.  170.545. These revisions are discussed in 
sections F. Certification Options for ONC-ACBs, O. Validity of Complete 
EHR and EHR Module Certification and Expiration of Certified Status and 
P. Differential or Gap Certification of this preamble.
2. EHR Modules
a. Applicable Certification Criterion or Criteria
    We proposed in Sec.  170.550(a) and (b) that an ONC-ACB must 
certify EHR Modules in accordance with the applicable certification 
criterion or criteria adopted by the Secretary at subpart C of part 
170. In the preamble of the Proposed Rule, we clarified that a single 
certification criterion would encompass all of the specific 
capabilities referenced below the first paragraph level. For example, 
45 CFR 170.302, paragraph ``(f)'' (the first paragraph level) 
identifies that this certification criterion relates to recording and 
charting vital signs. It includes three specific capabilities at 
(f)(1), (2), and (3) (the second paragraph level): the ability to 
record, modify, and retrieve patients' vital signs; the ability to 
calculate body mass index (BMI); and

[[Page 1291]]

the ability to plot and display growth charts. We stated that we viewed 
the entire set of specific capabilities required by paragraph ``(f)'' 
(namely, (f)(1), (2), and (3)) as one certification criterion. The 
specific capability to calculate BMI, for example, would not be 
equivalent to one certification criterion.
    Comments. We received two comments on our proposal. One commenter 
expressed agreement with our proposal, including the appropriateness of 
requiring an EHR Module to be capable of performing all the functions 
specified at the paragraph level of a certification criterion. The 
commenter reasoned that to allow certification at a lower level 
(subparagraph) would result in a very large number of EHR Modules that 
would overcomplicate the certification program. The commenter stated 
that the only exception might be if there were a very large number of 
subparagraphs within a criterion or a very large number of criteria 
within a single objective. In that case, the commenter asserted that 
the EHR Module might be divided into two or more logically related 
groups. But in general, the commenter stated that having a range of 20-
25 certification criteria, and therefore potential EHR Modules, was an 
appropriate level of granularity.
    The other commenter stated that requiring an EHR Module to perform 
all of the listed functions or capabilities associated with a specific 
certification criterion would create a problem. In particular, the 
commenter stated that for the ``drug-drug, drug-allergy, drug-formulary 
checks'' certification criterion specified in the HIT Standards and 
Certification Criteria interim final rule, there did not appear to be a 
single EHR Module in the current HIT marketplace that performs all of 
the four listed capabilities under the criterion. Therefore, the 
commenter recommended that we narrow the scope of EHR Module 
certification to one of the capabilities or functions (subparagraphs) 
of a criterion. The commenter stated that this solution would 
necessitate that the ONC-ACB provide EHR Modules that only perform such 
discrete functions with a ``conditional certification'' that carries 
the caveat that the EHR Module must be used in conjunction with other 
certified EHR Modules to offer full and complete functionality for the 
applicable criterion.
    Response. We agree with the first commenter that, as proposed, EHR 
Modules should be certified to the first paragraph level of a 
certification criterion, as described in our example above. We believe 
that this is the most appropriate level for certification of EHR 
Modules because, in most cases, this level of a criterion most fully 
represents the capabilities that are needed to perform the associated 
meaningful use objectives. We addressed the concern expressed by the 
other commenter about the ``drug-drug, drug-allergy, drug-formulary 
checks'' certification criterion by adopting separate certification 
criteria in the HIT Standards and Certification Criteria final rule.
    We are modifying Sec.  170.550 to remove proposed paragraph (b) 
because it is repetitive of the requirements set forth in paragraph 
(a). We made a similar modification to Sec.  170.450 in the Temporary 
Certification Program final rule.
b. Privacy and Security Certification
    With respect to EHR Modules, we discussed in the Proposed Rule when 
ONC-ACBs would be required to certify EHR Modules to the privacy and 
security certification criteria adopted by the Secretary. We proposed 
in Sec.  170.550(c) that EHR Modules must be certified to all privacy 
and security certification criteria adopted by the Secretary unless the 
EHR Module(s) is/are presented for certification in one of the 
following manners:
    <bullet> The EHR Module(s) are presented for certification as a 
pre-coordinated, integrated bundle of EHR Modules, which could 
otherwise constitute a Complete EHR. In such instances, the EHR 
Module(s) shall be certified in the same manner as a Complete EHR. Pre-
coordinated, integrated bundles of EHR Module(s) which include EHR 
Module(s) that would not be part of a local system and under the end 
user's direct control are excluded from this exception. The constituent 
EHR Modules of such a pre-coordinated, integrated bundle must be 
separately certified to all privacy and security certification 
criteria;
    <bullet> An EHR Module is presented for certification, and the 
presenter can demonstrate to the ONC-ACB that it would be technically 
infeasible for the EHR Module to be certified in accordance with some 
or all of the privacy and security certification criteria; or
    <bullet> An EHR Module is presented for certification, and the 
presenter can demonstrate to the ONC-ACB that the EHR Module is 
designed to perform a specific privacy and security capability. In such 
instances, the EHR Module may only be certified in accordance with the 
applicable privacy and security certification criterion/criteria.
    Comments. A number of commenters supported our proposed approach 
and agreed that EHR Modules should be certified to all adopted privacy 
and security certification criteria unless there were justifiable 
reasons for which they should not. Other commenters suggested changes 
to one or more of the stated exceptions and posed questions for our 
consideration. Some commenters recommended that we deem certification 
criteria ``addressable'' similar to the Health Insurance Portability 
and Accountability Act (HIPAA) Security Rule's application of the word 
``addressable'' to certain implementation specifications (in the HIPAA 
context) within a security standard (in the HIPAA context). Other 
commenters noted that with respect to the second exception, involving 
the demonstration that it would be technically infeasible for an EHR 
Module to be certified to some or all privacy and security 
certification criteria, that the term ``inapplicable'' should be added 
as a condition in addition to ``technically infeasible.'' Another 
commenter stated that we should remove the third exception, involving 
the demonstration that an EHR Module is designed to perform a specific 
privacy and security capability, because, depending on how the privacy 
and security EHR Module is developed, it may also need to include 
certain capabilities, such as an audit log.
    One commenter noted that, under the permanent certification 
program, an EHR Module developer would first be required to demonstrate 
to a testing laboratory that it is technically infeasible to certify an 
EHR Module to a particular privacy and security certification 
criterion, which would require the testing laboratory to make an 
independent subjective decision on technical feasibility. The commenter 
recommended that ONC and/or NIST develop an ``applicability matrix'' to 
reduce subjectivity and ensure consistent determinations among testing 
laboratories and ONC-ACBs related to the applicability of privacy and 
security certification criteria to EHR Modules. Another commenter 
expressed an understanding of our privacy and security certification 
approach to EHR Modules, but cautioned that to ensure the privacy and 
security of an EHR system in its entirety, that the entire combination 
needs to be tested for privacy and security due to variances that can 
occur in how EHR Modules perform once they are ``linked.'' The 
commenter suggested that an EHR Module developer should be required to

[[Page 1292]]

explain how the EHR Module will be ``securely'' assembled.
    Response. We appreciate commenters' support for our proposed 
approach and the thoughtfulness of the responses. While we understand 
and appreciate the similarities some commenters saw with respect to the 
HIPAA Security Rule and leveraging the ``addressable'' concept, we do 
not believe that making each privacy and security certification 
criterion ``addressable'' in the way it is implemented under the HIPAA 
Security Rule is an appropriate approach for the purposes of certifying 
EHR Modules.
    In the context of the HIPAA Security Rule, HIPAA covered entities 
must assess whether each addressable implementation specification (in 
the HIPAA Security Rule) is a reasonable and appropriate safeguard in 
its environment. If a HIPAA covered entity determines that an 
addressable implementation specification is reasonable and appropriate, 
then the covered entity is required to implement it. If a HIPAA covered 
entity determines that an addressable implementation specification is 
not reasonable and appropriate, the covered entity is required to: (1) 
document why it would not be reasonable and appropriate to implement 
the addressable implementation specification; and (2) implement an 
equivalent alternative measure if reasonable and appropriate. While 
this is a sensible approach for HIPAA covered entities, we do not 
believe that it translates well into the certification of EHR Modules.
    All HIPAA covered entities are required to comply with the HIPAA 
Security Rule with respect to their electronic protected health 
information, regardless of their size and resources. Accordingly, the 
HIPAA Security Rule provides for a flexible approach, allowing a HIPAA 
covered entity to implement safeguards that are reasonable and 
appropriate for its unique environment. We do not believe that this 
approach is appropriate for certifying EHR Modules because one purpose 
of certification is to assure eligible professionals and eligible 
hospitals that an EHR Module includes a specified capability or set of 
capabilities. For these reasons and as we concluded in the Temporary 
Certification Program final rule, we believe that the proposed standard 
of ``technically infeasible'' is more appropriate than the HIPAA 
Security Rule's ``addressable'' concept for the purposes of certifying 
EHR Modules. Thus, an EHR Module developer must satisfy each privacy 
and security criterion where it is technically feasible.
    To complement our ``technically infeasible'' standard, we agree 
with those commenters that recommended the addition of the word 
``inapplicable'' to the second proposed exception. We believe that in 
some cases a privacy and security certification criterion may be 
inapplicable to an EHR Module while technically feasible to implement, 
and in other cases a privacy and security certification criterion may 
be applicable but technically infeasible to implement. For example, it 
may be technically feasible to implement an automatic log-off or 
emergency access capability for several types of EHR Modules, but such 
capabilities may be inapplicable given the EHR Module's anticipated 
function and/or point of integration.
    In response to the comment regarding the assessment of privacy and 
security certification criteria by testing labs, we anticipate that an 
EHR Module developer would request a testing lab to only test the 
privacy and security certification criteria to which the EHR Module 
developer believes are appropriate for its EHR Module. In other words, 
a testing lab would test what is requested by an EHR Module developer 
and not be responsible for determining whether other privacy and 
security certification criteria (not requested for testing) may in fact 
be applicable or technically feasible for the EHR Module developer to 
implement. This responsibility would be an ONC-ACB's and, for the 
purposes of certification, we require that an individual or entity that 
presents an EHR Module for certification must provide sufficient 
documentation to the ONC-ACB to support its assertion that a particular 
privacy and security certification criterion is inapplicable or that 
satisfying the certification criterion is technically infeasible. Based 
on this documentation, the ONC-ACB shall independently assess and make 
a reasonable determination as to whether the EHR Module should be 
exempt from having to satisfy particular privacy or security 
certification criteria. As a result, there could be situations where 
despite an EHR Module developer's belief that a privacy and security 
certification criterion is inapplicable or technically infeasible an 
ONC-ACB makes a determination to the contrary. We believe that these 
instances would be the exception and not the rule but, nonetheless, we 
encourage EHR Module developers to carefully consider those privacy and 
security certification criteria they believe are inapplicable or 
technically infeasible prior to seeking testing. Finally, we recognize 
that this approach provides a certain amount of discretion among the 
ONC-ACBs, but we believe that any inconsistent application that emerges 
could be mitigated by guidance from the National Coordinator.
    A commenter expressed a concern about the overall privacy and 
security of a combination of EHR Modules. As we stated in the Proposed 
Rule and the HIT Standards and Certification Criteria interim final 
rule, it is incumbent on the eligible professional or eligible hospital 
to ensure that a combination of EHR Modules properly work together to 
meet all of the required capabilities necessary to meet the definition 
of Certified EHR Technology. Thus, the flexibility and customization 
provided through the use of EHR Modules may also include some 
additional work on the part of an eligible professional or eligible 
hospital to ensure that adopted EHR Modules properly work together. 
Alternatives to this custom approach, as we have discussed, include the 
adoption of Complete EHRs and pre-coordinated, integrated bundles of 
EHR Modules.
    We also agree with the commenter who stated that we should remove 
the third exception and simply require all EHR Modules, if not included 
in a pre-coordinated integrated bundle, to follow the same approach. As 
a result, and as we did in the context of the temporary certification 
program, only the first and second exception of proposed Sec.  
170.550(c) will be finalized. We recognize that, with respect to an EHR 
Module that is focused exclusively on providing one or more privacy and 
security capabilities, the remaining privacy and security certification 
criteria may be inapplicable or compliance with them may be technically 
infeasible. However, we do not believe it is prudent to presume that 
this will always be the case.
    Comments. Several commenters asked for clarification of the 
circumstances under which the first exception we proposed applied in 
relation to a pre-coordinated, integrated bundle of EHR Modules, the 
carve out to this exception related to EHR Modules that were ``not be 
part of a local system,'' and our use of the term ``end user.''
    Response. Overall, the premise behind the first exception is to 
omit the general requirement that each individual EHR Module must be 
certified to all of the adopted privacy and security criteria. We 
believe it would be pragmatic to eliminate this requirement in 
situations where several EHR Module developers (e.g., different 
vendors) or a single EHR Module developer presents a collection of EHR 
Modules as a pre-coordinated, integrated bundle to an ONC-ACB for

[[Page 1293]]

certification. In these circumstances, the pre-coordinated, integrated 
bundle of EHR Modules would otherwise meet the definition of and 
constitute a Complete EHR. Therefore, consistent with our approach in 
the Temporary Certification Program final rule, we clarify that in the 
circumstances where a pre-coordinated, integrated bundle of EHR Modules 
is presented for certification and one or more of the constituent EHR 
Modules is/are demonstrably responsible for providing all of the 
privacy and security capabilities for the entire bundle of EHR Modules, 
that those other EHR Modules would be exempt from being certified to 
the adopted privacy and security certification criteria. To illustrate, 
four EHR Module developers each develop one EHR Module (EHR Modules A, 
B, C, and D) and form an affiliation. The EHR Module developers present 
their EHR Modules for certification as a pre-coordinated, integrated 
bundle and identify that EHR Module ``C'' is responsible for providing 
the privacy and security capabilities for the rest of the entire bundle 
(EHR Modules A, B, and D). In this scenario, EHR Modules A, B, and D 
would be exempt from also being certified to the adopted privacy and 
security certification criteria.
    With respect to the proposed carve out to this exception related to 
EHR Modules that would ``not be part of a local system,'' we sought to 
limit those circumstances where a group of EHR Module developers could 
claim that a collection of EHR Modules was a ``pre-coordinated, 
integrated bundle,'' yet it would be technically infeasible for one or 
all of the EHR Modules in the collection to be demonstrably responsible 
for providing all of the privacy and security capabilities for the rest 
of the EHR Modules. We believe this would occur in situations where a 
``pre-coordinated, integrated bundle'' of EHR Modules includes one or 
more services offered by different EHR Module developers that have been 
implemented on different technical architectures or hosted over the 
Internet on one or multiple different servers. In this situation we do 
not believe that it would be possible for one or more of the EHR 
Modules to be demonstrably responsible for providing all of the privacy 
and security capabilities for the rest of the EHR Modules. For example, 
we do not believe that it is possible, at the present time, for a web-
based EHR Module to offer authentication for another EHR Module that 
may be installed on an eligible professional's laptop, nor do we 
believe that one or more web-based services could provide an audit log 
for actions that took place outside of that service.
    We believe that with this additional clarity the explicit mention 
of the first exception's carve out is no longer necessary and have 
revised the first exception accordingly to include the clarifying 
concepts we discuss above. This revision has also resulted in the 
removal of the term ``end user,'' which commenters requested we 
clarify. We are redesignating proposed Sec.  170.550(c) as Sec.  
170.550(e). The entire provision at Sec.  170.550(e), including the 
changes from both of our responses above, will read:
    EHR Modules shall be certified to all privacy and security 
certification criteria adopted by the Secretary unless the EHR 
Module(s) is presented for certification in one of the following 
manners:
    (1) The EHR Modules are presented for certification as a pre-
coordinated, integrated bundle of EHR Modules, which would otherwise 
meet the definition of and constitute a Complete EHR, and one or more 
of the constituent EHR Modules is demonstrably responsible for 
providing all of the privacy and security capabilities for the entire 
bundle of EHR Modules; or
    (2) An EHR Module is presented for certification, and the presenter 
can demonstrate and provide documentation to the ONC-ACB that a privacy 
and security certification criterion is inapplicable or that it would 
be technically infeasible for the EHR Module to be certified in 
accordance with such certification criterion.
We made similar modifications to Sec.  170.450(c) in the Temporary 
Certification Program final rule.
    We would like to clarify a few points related to pre-coordinated, 
integrated bundles of EHR Modules. First, a pre-coordinated, integrated 
bundle of EHR Modules will qualify for the exception at Sec.  
170.550(e)(1) if, and only if, the bundle would otherwise meet the 
definition of and constitute a Complete EHR. In other words, the pre-
coordinated, integrated bundle of EHR Modules must meet, at a minimum, 
all of the applicable certification criteria adopted by the Secretary 
in subpart C of part 170, even though the bundle and its constituent 
EHR Modules would not have been developed as a Complete EHR. For 
example, three EHR Modules may be integrated and ``bundled'' together, 
but if the bundle does not satisfy all of the applicable certification 
criteria that have been adopted, it will not qualify for this specific 
exception. In those cases, we would view such a bundle as an EHR Module 
that provides multiple capabilities. Second, because a pre-coordinated, 
integrated bundle of EHR Modules would otherwise meet the definition of 
and constitute a Complete EHR, we expect to list it as a ``Complete 
EHR'' and not an ``EHR Module'' on the CHPL, but would provide a 
designation noting that it is a pre-coordinated, integrated bundle of 
EHR Modules. Based on experience, we may determine that a more 
effective method for listing pre-coordinated, integrated bundles of EHR 
Modules on the CHPL would be appropriate and will periodically evaluate 
if another method would be beneficial. As previously discussed in this 
preamble, we expect ONC-ACBs will specifically identify pre-
coordinated, integrated bundles of EHR Modules as part of their 
reporting obligations under Sec.  170.523(f). Finally, in case it is 
unclear from the context, we clarify that references to EHR Module(s) 
in other provisions of Sec.  170.550 are intended to include pre-
coordinated, integrated bundles of EHR Modules.
    Comments. A few commenters requested that we clarify whether there 
could be specific privacy and security-focused EHR Modules. That is, in 
the context of the definition of EHR Module, whether we intended to 
permit EHR Modules to exist that only addressed one or more adopted 
privacy and security certification criteria. One commenter asked for 
clarification as to whether a specific privacy and security-focused EHR 
Module would meet a certification criterion if its purpose was to call 
or assign the actual capability required by a certification criterion 
to another function or service.
    Response. Yes, as we stated in the Temporary Certification Program 
final rule, we believe that there could be specific privacy and 
security-focused EHR Modules and do not preclude such EHR Modules from 
being presented for certification. However, with respect to the second 
comment and request for clarification, we believe that an EHR Module 
itself must be capable of performing a capability required by an 
adopted privacy and security certification criterion and that 
delegating the responsibility to another service or function would not 
be acceptable. In those cases, there would be no proof that the EHR 
Module could actually perform the specific capability, only that it 
could direct another service or function to do it.
c. Identification of Certified Status
    We proposed in Sec.  170.550(d) to require ONC-ACBs authorized to 
certify EHR Modules to clearly indicate the certification criterion or 
criteria to which an EHR Module has been certified in the EHR Module's 
certification documentation.

[[Page 1294]]

    Comments. We received two comments requesting that we standardize 
the certification documentation requirements or at least provide clear 
guidelines for ``certificate'' design. The commenters were concerned 
that if left to the discretion of ONC-ACBs, the resulting certification 
``certificates'' could look quite different and result in marketplace 
confusion. One commenter recommended that the certification 
``certificate,'' which will figure prominently in EHR software vendor 
marketing, should be uniform in appearance and depict HHS authority and 
assurance.
    Response. We agree with the commenters that ``certificate'' 
documentation should be designed in a way that does not lead to market 
confusion. Therefore, we are establishing a new Principle of Proper 
Conduct for ONC-ACBs regarding the proper identification of Complete 
EHRs and EHR Modules, similar to the new Principle of Proper Conduct 
for ONC-ATCBs we finalized in the Temporary Certification Program final 
rule. We further discuss the basis for this new Principle of Proper 
Conduct for ONC-ACBs under the heading titled ``O. Validity of Complete 
EHR and EHR Module Certification and Expiration of Certified Status'' 
later in this preamble. Consistent with this decision, we are modifying 
Sec.  170.550 to remove proposed paragraph (d). This modification will 
eliminate any potential redundancy with the new Principle of Proper 
Conduct on the proper identification of Complete EHRs and EHR Modules.
3. Other Types of HIT
    We proposed in Sec.  170.553 that an ONC-ACB could be authorized to 
certify HIT, other than Complete EHRs and/or EHR Modules, in accordance 
with the applicable certification criterion or criteria adopted by the 
Secretary at subpart C of part 170. In association with this proposed 
provision, we invited public comment on the need for additional HIT 
certifications, the types of HIT that would be appropriate for 
certification, and on any of the potential benefits or challenges 
associated with certifying other types of HIT.
    Comments. We received numerous comments on our proposal to utilize 
the permanent certification program for the certification of other 
types of HIT, with commenters overwhelmingly in favor of this proposal. 
Commenters also made suggestions of other types of HIT that could be 
certified, such as personal health records, health information 
organizations, pharmacy and laboratory systems, ancillary clinical 
systems including radiology information systems, picture archiving and 
communication systems, cardiology systems, vital signs and point-of-
care medical devices, and telehealth and remote patient care solutions. 
Conversely, a few commenters did not believe that there was a current 
need for the certification of other types of HIT and suggested that we 
should first determine whether a private market would develop for the 
certification of other types of HIT. A few other commenters suggested 
that the permanent certification program should first focus on the 
certification of Complete EHRs and EHR Modules and that further 
certification of other types of HIT should be done with the intent of 
supporting meaningful use efforts.
    Response. We appreciate the support for the certification of other 
types of HIT under the permanent certification program. Consistent with 
our discussion in the Proposed Rule, we maintain that section 
3001(c)(5) of the PHSA provides the National Coordinator with the 
authority to establish a voluntary certification program or programs 
for other types of HIT besides Complete EHRs and EHR Modules. We agree 
with the commenters, however, that the initial focus of the permanent 
certification program should be on the certification of Complete EHRs 
and EHR Modules in support of efforts by eligible professionals and 
eligible hospitals who seek to demonstrate meaningful use under the 
Medicare and Medicaid EHR Incentive Programs. Moreover, as we stated in 
the Proposed Rule, the Secretary must first adopt certification 
criteria applicable to other types of HIT before the National 
Coordinator could subsequently authorize an ONC-ACB to certify such HIT 
under the permanent certification program. In the event that the 
Secretary adopts such applicable certification criteria and future 
circumstances suggest the need or demand for the certification of other 
types of HIT, we will further consider the comments received in 
determining how to proceed, including those comments suggesting 
specific types of other HIT that would be appropriate for 
certification. As previously noted in this preamble, if the scope of 
the permanent certification program is eventually expanded to include 
other types of HIT, certification would not constitute a replacement or 
substitution for other Federal requirements that may be applicable to 
those other types of HIT. Consistent with this discussion, we are 
finalizing Sec.  170.553 without modification.

J. Certification of ``Minimum Standards''

    In the Proposed Rule, we summarized the approach set forth in the 
HIT Standards and Certification Criteria interim final rule (75 FR 
2014) to treat certain vocabulary code set standards as ``minimum 
standards.'' We noted that the establishment of ``minimum standards'' 
for specific adopted code sets would, in certain circumstances, allow a 
Complete EHR and/or EHR Module to be tested and certified to a 
permitted newer version of an adopted code set without the need for 
additional rulemaking. Additionally, we noted that this approach would 
enable Certified EHR Technology to be upgraded to a permitted newer 
version of a code set without adversely affecting its certified status.
    At the end of this summary, we reiterated a previously identified 
limitation of the ``minimum standards'' approach with respect to 
significant revisions to adopted code sets. We stated that a newer 
version of an adopted ``minimum standard'' code set would be permitted 
for use in testing and certification unless it was a significant 
revision to a code set that represented a ``modification, rather than 
maintenance or a minor update of the code set.'' In those cases, we 
reiterated that the Secretary would likely proceed with notice and 
comment rulemaking to adopt a significantly revised code set standard.
    We proposed two methods through which the Secretary could identify 
new versions of adopted ``minimum standard'' code sets. The first 
method would allow any member of the general public to notify the 
National Coordinator about a new version. Under the second method, the 
Secretary would proactively identify newly published versions. After a 
new version has been identified, a determination would be issued as to 
whether the new version constitutes maintenance efforts or minor 
updates to the adopted code set and consequently may be permitted for 
use in certification. We proposed, as described in Sec.  170.555, that 
once the Secretary has accepted a new version of an adopted ``minimum 
standard'' code set that:
    (1) Any ONC-ACB may test and certify Complete EHRs and/or EHR 
Modules according to the new version;
    (2) Certified EHR Technology may be upgraded to comply with the new 
version of an adopted minimum standard accepted by the Secretary 
without adversely affecting the certification status of the Certified 
EHR Technology; and

[[Page 1295]]

    (3) ONC-ACBs would not be required to test and certify Complete 
EHRs and/or EHR Modules according to the new version until we updated 
the incorporation by reference of the adopted version to a newer 
version.
    Finally, we stated that for either method, we would regularly 
publish on a quarterly basis, either by presenting to the HIT Standards 
Committee or by posting a notification on our Web site, any Secretarial 
determinations that have been made with respect to ``minimum standard'' 
code sets. We requested public comment on the frequency of publication, 
any other approaches we should consider to identify newer versions of 
adopted code set standards, and whether both methods described above 
should be used.
    Comments. Many commenters supported our proposed approaches. These 
commenters also encouraged us to pursue both of the proposed approaches 
(notification of the National Coordinator by the general public and 
proactive identification by the Secretary). Some commenters recommended 
that we establish open lines of communication with the organizations 
responsible for maintaining identified ``minimum standard'' code sets 
in order to facilitate the process of identifying newer versions.
    Response. We appreciate the commenters' support for our proposals. 
We first note that we inadvertently referenced ``testing'' in proposed 
Sec.  170.555. As specified in this final rule, the National 
Coordinator will authorize ONC-ACBs to perform certifications and not 
testing under the permanent certification program. Therefore, we are 
removing references to ``testing'' in Sec.  170.555. Second, based on 
the commenters' feedback, we have decided to adopt both of the proposed 
approaches for the permanent certification program, as we did for the 
temporary certification program. In addition, we expect to work, as 
appropriate, with the maintenance organizations for the ``minimum 
standard'' code sets, as well as the HIT Standards Committee, to 
identify new versions when they become available.
    Comments. A few commenters recommended that ONC-ACBs not be 
required to use an accepted newer version of a ``minimum standard'' 
code set for certification. Along those lines, a few other commenters 
recommended that there be a delay period between the Secretary's 
acceptance of a new version and when it would be required for 
certification. One commenter noted that supporting multiple versions of 
standards should be avoided and that there would be differences in what 
was certified versus what was implemented, while another commenter 
noted that even permitting the use of a minor update could affect 
interoperability. Some commenters specifically requested clarification 
regarding the timeline associated with the Secretary's acceptance of a 
newer version and its publication and what requirement there would be 
for its inclusion in certification.
    Response. We believe that some commenters misunderstood the 
implications of the Secretary's acceptance of a newer version of a 
``minimum standard'' code set. We therefore clarify that if the 
Secretary accepts a newer version of a ``minimum standard'' code set, 
nothing is required of ONC-ACBs, Complete EHR or EHR Module developers, 
or the eligible professionals and eligible hospitals who have 
implemented Certified EHR Technology. We provided similar clarification 
for the temporary certification program in the final rule establishing 
that program. In the Proposed Rule, we used a three-pronged approach in 
order to provide greater flexibility and accommodate industry practice 
with respect to code sets that must be maintained and frequently 
updated. The first prong would permit, but not require, ONC-ACBs to use 
an accepted newer version of a ``minimum standard'' code set to certify 
Complete EHRs and/or EHR Modules if the accepted newer version has been 
incorporated into a product by a Complete EHR or EHR Module developer. 
In these instances, we believe this approach benefits Complete EHR or 
EHR Module developers because they would be able to adopt a newer 
version of a code set voluntarily and have their Complete EHR or EHR 
Module certified according to it, rather than having to use an older 
version for certification. The second prong would permit, but not 
require, eligible professionals and eligible hospitals who are already 
using Certified EHR Technology to receive an upgrade from their 
Complete EHR or EHR Module developer or voluntarily upgrade themselves 
to an accepted newer version of a ``minimum standard'' code set without 
adversely affecting the certification status of their Certified EHR 
Technology. Again, we believe this is a benefit to eligible 
professionals and eligible hospitals and provides greater flexibility. 
The third prong explicitly states that an ONC-ACB would not be required 
to use any other version of a ``minimum standard'' code set beyond the 
one adopted at 45 CFR 170 subpart B until the Secretary incorporates by 
reference a newer version of that code set.
    We recognize that a few different versions of adopted ``minimum 
standards'' could all be implemented at the same time and before a 
subsequent rulemaking potentially changes what constitutes the 
``minimum.'' We also understand the point raised by the commenter who 
expressed concerns about this approach because it could potentially 
create a situation where there could be differences in what was 
certified versus what was implemented. Along those lines, we also 
appreciate the point made by the commenter that a minor update could 
affect interoperability. We acknowledge these concerns and considered 
them as part of our analysis in determining whether to adopt minimum 
standards and to permit such standards to be exceeded when newer 
versions had been made available for use. However, we would like to 
make clear that we provide this flexibility on a voluntary basis and 
believe that the benefit of accepting newer versions of a ``minimum 
standard'' (namely, enabling the HIT industry to keep pace with new 
code sets) outweighs any potential or temporary risk to 
interoperability.
    In light of the discussion above, we do not believe it is necessary 
to change any of our proposals, and we hope the additional 
clarification above addresses the concerns and questions raised by 
commenters. Accordingly, except for removing references to ``testing,'' 
we are finalizing Sec.  170.555 without modification.
    Comments. Some commenters requested that we clarify the process the 
Secretary would follow before accepting a newer version of an adopted 
``minimum standard'' code set, including specifying the timeframes for 
publication.
    Response. We expect that after a new version of an adopted 
``minimum standard'' code set has been identified (either through the 
general public's notification of the National Coordinator or the 
Secretary proactively identifying its availability), the National 
Coordinator would ask the HIT Standards Committee to assess and solicit 
public comment on the new version. We expect that the HIT Standards 
Committee would subsequently issue a recommendation to the National 
Coordinator which would identify whether the Secretary's acceptance of 
the newer version for voluntary implementation and certification would 
burden the HIT industry, negatively affect interoperability, or cause 
some other

[[Page 1296]]

type of unintended consequence. After considering the recommendation of 
the HIT Standards Committee, the National Coordinator would determine 
whether or not to seek the Secretary's acceptance of the new version of 
the adopted ``minimum standard'' code set. If the Secretary approves 
the National Coordinator's request, we would issue guidance on an 
appropriate but timely basis indicating that the new version of the 
adopted ``minimum standard'' code set has been accepted by the 
Secretary.

K. Authorized Certification Methods

    We proposed in Sec.  170.557 that, as a primary method, an ONC-ACB 
would be required to be capable of certifying Complete EHRs and/or EHR 
Modules at its facility. We also proposed that an ONC-ACB would be 
required to have the capacity to certify Complete EHRs and/or EHR 
Modules through one of the following secondary methods: at the site 
where the Complete EHR or EHR Module has been developed; or at the site 
where the Complete EHR or EHR Module resides; or remotely (i.e., 
through other means, such as through secure electronic transmissions 
and automated web-based tools, or at a location other than the ONC-
ACB's facility).
    Comments. We received many comments on our proposal. We received 
varying recommendations and proposals, but the majority of commenters 
did not agree with certification at an ONC-ACB's facility as the 
primary method. Commenters noted that to require eligible professionals 
or eligible hospitals with self-developed Complete EHRs to physically 
move their Complete EHRs to another location for certification would 
not only be burdensome but in many cases impossible. Instead, many 
commenters recommended that we require ONC-ACBs to have the capacity to 
certify products through all of the secondary methods we proposed. Some 
commenters supported secondary methods without preference, while many 
commenters recommended that we require ONC-ACBs to offer remote 
certification as the primary method because of its efficiency and low 
cost to Complete EHR and EHR Module developers. Commenters also noted 
that ONC-ACBs could offer other methods, including performing 
certification at an ONC-ACB's facility. One commenter recommended that, 
as the primary method, ONC-ACBs should be required to support 
certification at the Complete EHR or EHR Module developer's site, which 
could include a development or deployment site. Another commenter 
stated that each method should be considered equal because different 
methods may be appropriate for different developers. Some commenters 
recommended that we clarify whether we expected Complete EHRs and EHR 
Modules to be ``live'' at customer sites before they can be certified. 
The commenters asserted that such a prerequisite will significantly 
delay the roll out of customer upgrades.
    Response. We appreciate the many options and preferences expressed 
by the commenters. We believe that in order to adequately and 
appropriately address the commenters' concerns, an ONC-ACB must have 
the capacity to provide remote certification for both development and 
deployment sites. For the purposes of the permanent certification 
program, a development site is the physical location where a Complete 
EHR, EHR Module or other type of HIT was developed. For the purposes of 
the permanent certification program, a deployment site is the physical 
location where a Complete EHR, EHR Module or other type of HIT resides 
or is being or has been implemented. As discussed in the Proposed Rule, 
remote certification would include the use of methods that do not 
require the ONC-ACB to be physically present at the development or 
deployment site. This could include the use of web-based tools or 
secured electronic transmissions. In addition to remote certification, 
an ONC-ACB may also offer certification at its facility or at the 
physical location of a development or deployment site, but we are not 
requiring that an ONC-ACB offer such certification. As indicated by 
commenters and our own additional research, the market currently 
utilizes predominantly remote methods for the certification of HIT. On-
site certification was cited as costly and inefficient. Therefore, 
consistent with our requirements of ONC-ATCBs under the temporary 
certification program, we are not requiring ONC-ACBs to offer such 
certification, but anticipate that some ONC-ACBs will offer on-site 
certification if there is a market demand. In response to those 
commenters who requested clarification regarding ``live'' 
certification, we want to make clear that we do not believe that a 
Complete EHR, EHR Module or other type of HIT must be ``live at a 
customer's site'' in order to qualify for certification by an ONC-ACB. 
As stated above, a Complete EHR, EHR Module or other type of HIT could 
be certified at the development site of a developer of Complete EHRs, 
EHR Modules or other types of HIT. Consistent with this discussion, we 
are revising Sec.  170.557 to require an ONC-ACB to provide remote 
certification for both development and deployment sites and have 
included the definitions of ``development site,'' ``deployment site,'' 
and ``remote certification'' in Sec.  170.502.

L. Good Standing as an ONC-ACB, Revocation of ONC-ACB Status, and 
Effect of Revocation on Certifications Issued by a Former ONC-ACB

    We proposed requirements that ONC-ACBs would need to meet in order 
to maintain good standing under the permanent certification program, 
the processes for revoking an ONC-ACB's status for failure to remain in 
good standing, the effects that revocation would have on a former ONC-
ACB, and the potential effects that revocation could have on 
certifications issued by a former ONC-ACB.
1. Good Standing as an ONC-ACB
    We proposed in Sec.  170.560 that, in order to maintain good 
standing, an ONC-ACB would be required to adhere to the Principles of 
Proper Conduct for ONC-ACBs; refrain from engaging in other types of 
inappropriate behavior, including misrepresenting the scope of its 
authorization or certifying Complete EHRs and/or EHR Modules for which 
it was not given authorization; and follow all applicable Federal and 
State laws.
    Comments. Commenters expressed appreciation for our proposed 
standards of conduct for ONC-ACBs. One commenter encouraged us to 
evaluate compliance with the Principles of Proper Conduct on an ongoing 
basis and at the time for ``re-authorization,'' particularly if either 
a Type-1 or Type-2 violation had occurred.
    Response. We believe that our proposed Principles of Proper Conduct 
for ONC-ACBs are essential to maintaining the integrity of the 
permanent certification program, as well as ensuring public confidence 
in the program and the Complete EHRs, EHR Modules, and other types of 
HIT that may be certified under the program. We intend to monitor 
compliance with the Principles of Proper Conduct for ONC-ACBs on an 
ongoing basis by, among other means, ensuring that ONC-ACBs are 
attending all mandatory ONC training. It is also expected that ONC-ACBs 
will maintain relevant documentation of their compliance with the 
Principles of Proper Conduct for ONC-ACBs because such documentation 
would be necessary, for instance, to rebut a notice of noncompliance 
with the Principles of Proper Conduct issued by the National 
Coordinator under Sec.  170.565. At the time of renewal, an ONC-ACB 
will be assessed based on the updated

[[Page 1297]]

application it provides in accordance with Sec.  170.540, which would 
entail reviewing an ONC-ACB's current accreditation and adherence to 
the Principles of Proper Conduct. Accordingly, we are finalizing Sec.  
170.560 without modification.
2. Revocation of ONC-ACB Status
    We proposed in Sec.  170.565 that the National Coordinator could 
revoke an ONC-ACB's status if it committed a Type-1 violation or if it 
failed to timely or adequately correct a Type-2 violation. We defined 
Type-1 violations to include violations of law or permanent 
certification program policies that threaten or significantly undermine 
the integrity of the permanent certification program. These violations 
include, but are not limited to: false, fraudulent, or abusive 
activities that affect the permanent certification program, a program 
administered by HHS or any program administered by the Federal 
government.
    We defined Type-2 violations as noncompliance with Sec.  170.560, 
which would include without limitation, failure to adhere to the 
Principles of Proper Conduct for ONC-ACBs, engaging in other types of 
inappropriate behavior, or failing to follow other applicable laws. We 
proposed that if the National Coordinator were to obtain reliable 
evidence that an ONC-ACB may no longer be in compliance with Sec.  
170.560, the National Coordinator would issue a noncompliance 
notification. We proposed that an ONC-ACB would have 30 days from 
receipt of a noncompliance notification to submit a written response 
and accompanying documentation that demonstrates that no violation 
occurred or that the alleged violation had been corrected. We further 
proposed that the National Coordinator would have up to 30 days from 
the time the response is received to evaluate the response and 
determine whether a violation had occurred and whether it had been 
adequately corrected.
    We proposed that the National Coordinator could propose to revoke 
an ONC-ACB's status if the ONC-ACB committed a Type-1 violation. We 
proposed that the National Coordinator could propose to revoke an ONC-
ACB's status if, after an ONC-ACB has been notified of a Type-2 
violation, the ONC-ACB fails to rebut an alleged Type-2 violation with 
sufficient evidence showing that the violation did not occur or that 
the violation had been corrected, or if the ONC-ACB did not submit a 
written response to a Type-2 noncompliance notification within the 
specified timeframe. We proposed that an ONC-ACB would have up to 10 
days from receipt of the proposed revocation notice to submit a written 
response explaining why its status should not be revoked. We proposed 
that the National Coordinator would have up to 30 days from the time 
the response is received to review the information submitted by the 
ONC-ACB and reach a decision. We further proposed that an ONC-ACB would 
be able to continue its operations under the permanent certification 
program during the time periods provided for the ONC-ACB to respond to 
a proposed revocation notice and the National Coordinator to review the 
response.
    We proposed that if the National Coordinator determined that an 
ONC-ACB's status should not be revoked, the National Coordinator would 
notify the ONC-ACB's authorized representative in writing of the 
determination. We also proposed that the National Coordinator could 
revoke an ONC-ACB's status if it is determined that revocation is 
appropriate after considering the ONC-ACB's response to the proposed 
revocation notice or if the ONC-ACB did not respond to a proposed 
revocation notice within the specified timeframe. We further proposed 
that a decision to revoke an ONC-ACB's status would be final and not 
subject to further review unless the National Coordinator chose to 
reconsider the revocation.
    We proposed that a revocation would be effective as soon as the 
ONC-ACB received the revocation notice. We proposed that a 
certification body that had its ONC-ACB status revoked would be 
prohibited from accepting new requests for certification and would be 
required to cease its current certification operations under the 
permanent certification program. We further proposed that if a 
certification body had its ONC-ACB status revoked for a Type-1 
violation, it would be prohibited from reapplying for ONC-ACB status 
under the permanent certification program for one year.
    We proposed that failure to promptly refund any and all fees for 
uncompleted certifications of Complete EHRs and EHR Modules after the 
revocation of ONC-ACB status would be considered a violation of the 
Principles of Proper Conduct for ONC-ACBs. We proposed that the 
National Coordinator would consider such violations in the event that a 
certification body reapplied for ONC-ACB status under the permanent 
certification program.
    In association with these proposals, we specifically requested that 
the public comment on three additional proposals. First, we requested 
that the public comment on whether the National Coordinator should 
consider proposing the revocation of an ONC-ACB's status for repeatedly 
committing Type-2 violations even if the ONC-ACB adequately corrected 
the violations each time. In conjunction with this request, we asked 
how many corrected Type-2 violations would be sufficient for proposing 
revocation of an ONC-ACB and to what extent the frequency of these 
violations should be a consideration. Second, we requested that the 
public comment on whether the proposed 1-year bar on reapplying for 
ONC-ACB status imposed on a revoked certification body should be 
shortened or lengthened and whether alternative sanctions should be 
considered. In addition we noted that, depending on the type of 
violation that led to the former ONC-ACBs status being revoked, it was 
possible that the former ONC-ACB would also lose its accreditation. 
Third, we requested that the public comment on whether the National 
Coordinator should also include a process to suspend an ONC-ACB's 
status.
    Comments. We received general support for our proposed revocation 
process with commenters encouraging us to take a stringent position 
regarding Type-1 and Type-2 violations out of concern that a lack of 
confidence in the qualifications or integrity of an ONC-ACB could 
seriously undermine the permanent certification program's objectives. 
Commenters requested that developers of HIT and eligible professionals 
and eligible hospitals be notified if an ONC-ACB is suspended, the 
National Coordinator proposes to revoke an ONC-ACB's status, and/or an 
ONC-ACB's status is revoked.
    A commenter recommended that there not be a ``broad'' categorical 
Type-1 violation bar on reapplying for ONC-ACBs that had their status 
revoked. A few commenters suggested a shorter bar on reapplying could 
be possible if the organization demonstrated good faith and timely 
addressed the reasons for revocation, while other commenters supported 
the proposed 1-year bar or extending the bar to at least three years. 
Commenters recommending a longer bar on reapplying reasoned that a 
longer bar would be a stronger deterrent and provide sufficient time 
for a certification body to ``re-organize'' itself. These commenters 
also recommended that a ``re-authorized'' former ONC-ACB serve a 
probationary period. A commenter recommended that an ONC-ACB should 
have its accreditation permanently revoked if it commits three Type-1 
violations. The commenter also noted that it was unlikely that the 
market

[[Page 1298]]

would support an ONC-ACB that committed repeated violations.
    We received a few comments on whether we should revoke an ONC-ACB's 
status for committing multiple Type-2 violations even if the violations 
were corrected. A couple of commenters suggested that an ONC-ACB should 
have its status revoked for committing multiple violations. One 
commenter recommended that the National Coordinator retain the 
discretion to review and judge each situation as opposed to setting a 
certain threshold for automatic revocation.
    We received multiple comments on our proposed alternative of a 
suspension process with all of the commenters suggesting that there 
could be value in a suspension process. One commenter stated that our 
goal should be first and foremost to protect the needs of product 
purchasers and patients. Commenters stated that suspension could be 
warranted in lieu of proposing revocation and/or during the period 
between a proposed revocation and a final decision on revocation. Some 
commenters recommended that an ONC-ACB be allowed to continue 
operations during a suspension or be provided ``due process'' rights 
before being suspended, while other commenters suggested that allowing 
an ONC-ACB to continue during instances where an investigation is 
ongoing and violations are being resolved could jeopardize the 
industry's confidence level in the certification process. One commenter 
suggested that an ONC-ACB be allowed to continue operations unless the 
alleged violation would or could adversely impact patient safety and/or 
quality of care. Some commenters also requested that the fees paid by a 
Complete EHR and/or EHR Module developer for certification be refunded 
if the ONC-ACB is suspended.
    Response. We believe that Type-1 violations as described are not 
too ``broad'' in that they must also ``threaten or significantly 
undermine the integrity of the permanent certification program.'' As 
noted in the Proposed Rule, we believe such a violation could 
significantly undermine the public's faith in our permanent 
certification program. Therefore, we believe that revocation and 
barring a former ONC-ACB from reapplying for ONC-ACB status is an 
appropriate remedy. In reaching any conclusion to revoke an ONC-ACB's 
status, we believe that we have provided appropriate due process (i.e., 
an appropriate appeals process).
    We noted in the Temporary Certification Program final rule that we 
believed a 1-year bar on reapplying for ONC-ACB status was appropriate 
for the temporary certification program, but we would reconsider the 
appropriate length of the bar and whether a probationary period would 
be appropriate for the permanent certification program. Having 
considered these issues in the context of the permanent certification 
program, we continue to believe that a 1-year bar on reapplying is 
appropriate and have adopted this position for the permanent 
certification program. We believe that the l-year bar on reapplying 
will allow the former ONC-ACB a sufficient amount of time to address 
the reasons for the Type-1 violation before reapplying. In addition, 
when assessing a former ONC-ACB's application for ``reinstatement,'' we 
will be able to determine if the applicant is accredited by the ONC-AA. 
The accreditation process, itself, will be managed by the ONC-AA in 
accordance with ISO 17011. The ONC-AA will be responsible for 
determining appropriate sanctions for non-conformance with 
accreditation requirements in accordance with ISO 17011 and its 
accreditation program. However, considering accreditation is a 
requirement to become an ONC-ACB, we believe that accreditation will be 
another means of ensuring that a former ONC-ACB has fully addressed the 
reasons for revocation and, therefore, do not believe that a 
``probationary period'' will be necessary. Once ``re-authorized,'' an 
ONC-ACB will be subject to the same requirements for maintaining its 
status and consequences for not adhering to those requirements.
    We do not believe that it is appropriate to initiate revocation 
proceedings against an ONC-ACB for any amount of corrected Type-2 
violations under the permanent certification program. We did not 
originally propose to initiate revocation proceedings for multiple 
corrected Type-2 violations, but requested public comment on the 
possibility. Commenters appeared to agree that initiating revocation 
proceedings against an ONC-ACB for committing multiple Type-2 
violations, even if corrected, was an acceptable proposition under 
certain conditions. While we agree that committing multiple Type-2 
violations, even if corrected, is cause for concern, it would be 
difficult to establish a sufficiently objective and equitable standard 
for initiating revocation proceedings on that basis against an ONC-ACB. 
As evidenced by the comments, it is difficult to determine the 
appropriate number of corrected Type-2 violations that would lead to 
revocation proceedings. An ONC-ACB could commit and correct two Type-2 
violations involving a missed training or a timely update to ONC on a 
key personnel change. In such a situation, we do not believe that 
automatically initiating revocation proceedings would be warranted. We 
also do not believe it would be appropriate to adopt the one 
commenter's recommendation to allow the National Coordinator to use 
discretion to address such instances. This would not give an ONC-ACB 
sufficient notice of what Type-2 violation, even if corrected, could 
lead to revocation proceedings nor an indication of the amount or 
frequency of the violations that could lead to revocation proceedings. 
Therefore, we believe that an ONC-ACB should remain in good standing if 
it sufficiently corrects a Type-2 violation, no matter how many times 
an ONC-ACB commits a Type-2 violation. Violations will be a matter of 
public record that, as noted by a commenter, may influence Complete 
EHR, EHR Module and HIT developers' decisions on which ONC-ACB to 
select for the certification of their Complete EHRs, EHR Modules and/or 
other types of HIT.
    We agree with the commenters that suspension could be an effective 
way to protect purchasers of certified products and ensure patient 
health and safety. As a result, we agree with the commenter and believe 
that the National Coordinator should have the ability to suspend an 
ONC-ACB's operations under the permanent certification program when 
there is reliable evidence indicating that the ONC-ACB committed a 
Type-1 or Type-2 violation and that the continued certification of 
Complete EHRs, EHR Modules and/or other types of HIT could have an 
adverse impact on patient health or safety. As mentioned in the 
Proposed Rule, the National Coordinator's process for obtaining 
reliable evidence would involve one or more of the following methods: 
fact-gathering; requesting information from an ONC-ACB; contacting an 
ONC-ACB's customers; witnessing an ONC-ACB perform certification; and/
or reviewing substantiated complaints.
    Due to the disruption a suspension may cause for an ONC-ACB, and 
more so for the market, we believe that suspension is appropriate in 
only the limited circumstances described above and have revised Sec.  
170.565 to provide the National Coordinator with the discretion to 
suspend an ONC-ACB's operations accordingly. An ONC-ACB would first be 
issued a notice of proposed suspension. Upon receipt of a notice of 
proposed suspension, an ONC-ACB will be permitted up to 3

[[Page 1299]]

days to submit a written response to the National Coordinator 
explaining why its operations should not be suspended. The National 
Coordinator will be permitted up to 5 days to review the ONC-ACB's 
response and issue a determination. In the determination, the National 
Coordinator will either rescind the proposed suspension, suspend the 
ONC-ACB's operations until it has adequately corrected a Type-2 
violation, or propose revocation in accordance with Sec.  170.565(c) 
and suspend the ONC-ACB's operations for the duration of the revocation 
process. The National Coordinator may also make any one of the above 
determinations if an ONC-ACB fails to submit a timely response to a 
notice of proposed suspension. A suspension will become effective upon 
an ONC-ACB's receipt of a notice of suspension. We believe that this 
process addresses both the commenters' concerns about due process and 
about maintaining the industry's confidence in the permanent 
certification program by not allowing an ONC-ACB to continue operations 
while an investigation is ongoing and/or violations are being resolved 
related to patient health or safety.
    We are designating the new suspension provision as paragraph (d) of 
Sec.  170.565. Proposed paragraphs (d) through (g) are being 
redesignated as paragraphs (e) through (h), respectively. As discussed 
in a previous section of this preamble, we are revising Sec.  
170.523(j) to clarify that an ONC-ACB would have to refund any fees 
paid by a Complete EHR or EHR Module developer that seeks to withdraw a 
request for testing and certification while an ONC-ACB is suspended.
    We intend to provide public notification via our Web site and list 
serve if an ONC-ACB is suspended, issued a notice proposing its 
revocation, and/or has its status revoked. We also note that we are 
revising Sec.  170.565(c)(1) to state that ``[t]he National Coordinator 
may propose to revoke an ONC-ACB's status if the National Coordinator 
has reliable evidence that the ONC-ACB committed a Type-1 violation.'' 
The term ``reliable'' was inadvertently left out of the provision in 
the Proposed Rule.
3. Effect of Revocation on Certifications Issued by a Former ONC-ACB
    We proposed in Sec.  170.570 to allow the certified status of 
Complete EHRs and/or EHR Modules certified by an ONC-ACB that 
subsequently had its status revoked to remain intact unless a Type-1 
violation was committed that called into question the legitimacy of the 
certifications issued by the former ONC-ACB. In such circumstances, we 
proposed that the National Coordinator would review the facts 
surrounding the revocation of the ONC-ACB's status and publish a notice 
on ONC's Web site if the National Coordinator believed that Complete 
EHRs and/or EHR Modules were fraudulently certified by a former ONC-ACB 
and the certification process itself failed to comply with regulatory 
requirements. We further proposed that if the National Coordinator 
determined that Complete EHRs and/or EHR Modules were improperly 
certified, the ``certified status'' of affected Complete EHRs and/or 
EHR Modules would remain intact for 120 days after the National 
Coordinator published the notice. We specifically requested that the 
public comment on our proposed approach and the timeframe for re-
certification.
    Comments. Multiple commenters expressed agreement and understanding 
with the need to protect the integrity of the permanent certification 
program by ensuring the legitimacy of certifications issued by a former 
ONC-ACB and requiring recertification of Complete EHRs and/or EHR 
Modules where it is found that they were improperly certified. Many 
commenters stated, however, that we should only require recertification 
of the affected areas and elements and/or determine whether an 
improperly certified product negatively and substantially affected the 
performance of a Complete EHR or EHR Module in achieving a meaningful 
use objective before requiring recertification. Other commenters stated 
that ``good faith'' eligible professionals and eligible hospitals who 
can demonstrate meaningful use with a previously certified Complete EHR 
or EHR Module should continue to qualify for payments under the 
Medicare and Medicaid EHR Incentive Programs. Commenters further stated 
that providers should be allowed to wait and replace the previously 
certified product when new certification criteria have been finalized 
for the affected meaningful use criteria, or when their own strategic 
and technical requirements necessitate an upgrade, whichever comes 
first. Some commenters contended that the only overriding factor that 
should require recertification is if there is a demonstrable risk to 
patient safety from the use of improperly certified Complete EHRs and/
or EHR Modules.
    A few commenters expressed concerns about the potential negative 
financial impact recertification would have on Complete EHR and EHR 
Module developers, eligible professionals and eligible hospitals as 
well as the potential for legal liability related to eligible 
professionals and eligible hospitals making attestations to Federal and 
State agencies that they are using Certified EHR Technology.
    Some commenters agreed with our 120-day proposal, while many 
commenters recommended 6, 9, 12, and 18-month ``grace periods'' for 
improperly certified Complete EHRs and/or EHR Modules. One commenter 
recommended an extension of the 120-day grace period if there were less 
than 6 ONC-ACBs at the time of decertification, which is the number of 
ONC-ACBs we estimate will exist under the permanent certification 
program.
    Response. In instances where the National Coordinator determines 
that Complete EHRs and/or EHR Modules were improperly certified, we 
believe that recertification is necessary to maintain the integrity of 
the permanent certification program and to ensure the efficacy and 
safety of certified Complete EHRs and EHR Modules. By requiring 
recertification, eligible professionals and eligible hospitals as well 
as Complete EHR and EHR Module developers can have confidence in the 
permanent certification program and, more importantly, in the Complete 
EHRs and EHR Modules that are certified under the program. As we stated 
in the Proposed Rule, we believe it would be an extremely rare 
occurrence for an ONC-ACB to have its status revoked and for the 
National Coordinator to determine that Complete EHRs and/or EHR Modules 
were improperly certified. If such events were to occur, the regulatory 
provisions enable the National Coordinator to focus recertification on 
specific Complete EHRs and/or EHR Modules that were improperly 
certified in lieu of requiring recertification of all Complete EHRs and 
EHR Modules certified by the former ONC-ACB.
    In this regard, the National Coordinator has a statutory 
responsibility to ensure that Complete EHRs and EHR Modules certified 
under the permanent certification program are in compliance with the 
applicable certification criteria adopted by the Secretary. We do not 
believe that the alternatives suggested by the commenters, such as 
whether a ``good faith'' eligible professional or eligible hospital can 
demonstrate meaningful use with a previously certified Complete EHR or 
EHR Module, would enable the National Coordinator to fulfill this 
statutory responsibility. Consequently, if the National Coordinator 
determines that a Complete EHR or EHR Module was improperly certified, 
then recertification by an ONC-ACB is the

[[Page 1300]]

only means by which to ensure that the Complete EHR or EHR Module 
satisfies the certification criteria. Moreover, an attestation by a 
Complete EHR or EHR Module developer and/or user of a Complete EHR or 
EHR Module would not be an acceptable alternative to recertification 
because the National Coordinator could not sufficiently confirm that 
all applicable certification criteria are met.
    We appreciate the concerns expressed by commenters related to the 
potential financial burden of recertification, the potential legal 
liability for eligible professionals and eligible hospitals attesting 
to the use of Certified EHR Technology, and the perceived insufficient 
amount of time to have a Complete EHR and/or EHR Module recertified. We 
believe, however, that some of these concerns may be unfounded. Any 
decertification of a Complete EHR or EHR Module will be made widely 
known to the public by ONC through publication on our Web site and list 
serve, which we believe will help eligible professionals and/or 
eligible hospitals identify whether the certified status of their 
Certified EHR Technology is still valid. We also believe that 
programmatic steps, such as identifying ONC-ACB(s) that could be used 
for recertification, could be taken to assist Complete EHR and/or EHR 
Module developers with achieving timely and cost effective 
recertifications. Most importantly, in the rare circumstance that 
recertification is required, we believe that the need to protect the 
public from potentially unsafe Complete EHRs and/or EHR Modules 
outweighs the concerns expressed by the commenters. Accordingly, we are 
finalizing Sec.  170.570 without modification.

M. Dual-Accredited Testing and Certification Bodies

    In the Proposed Rule, we explained that the authorization given to 
ONC-ACBs by the National Coordinator would be valid only for performing 
certifications under the permanent certification program. We noted that 
this limitation was not intended to preclude an organization from also 
performing testing. In fact, we clarified that in order for a single 
organization (which may include subsidiaries or components) to perform 
both testing and certification under the permanent certification 
program it would need to be: 1) accredited by an ONC-AA and 
subsequently become an ONC-ACB; and 2) accredited under the NVLAP. We 
requested public comment on whether we should give organizations who 
are ``dual accredited'' and also become an ONC-ACB a special 
designation to indicate to the public that such an organization would 
be capable of performing both testing and certification under the 
permanent certification program.
    Comments. We received a few comments expressing support for the 
concept of allowing organizations to conduct both testing and 
certification under the permanent certification program and giving a 
special designation to such organizations. Commenters stated that it 
would be convenient and efficient for Complete EHR and EHR Module 
developers if organizations are permitted to conduct both testing and 
certification. A commenter also noted that a special designation would 
provide clarity for the market.
    Response. We agree with the commenters that organizations that are 
accredited and authorized to perform both testing and certification 
under the permanent certification program may be able to offer 
convenience and efficiencies as well as other benefits to HIT 
developers. We do note, however, that these types of organizations must 
adhere to the respective requirements of their accreditations. For 
instance, under the permanent certification program, ONC-ACBs must 
maintain their accreditation, which requires them to conform to Guide 
65 at a minimum. Several different sections of Guide 65 require 
certification bodies to maintain impartiality in their organizational 
structure and practices. The impartiality requirement will safeguard 
against the risk that the certification component of an organization 
will be improperly influenced to certify HIT that has been tested by 
the testing component of that same organization.
    We also agree with the commenters that a unique designation for 
organizations that are both ONC-ACBs and NVLAP-accredited testing labs 
is appropriate and will provide clarity to the market. We will indicate 
on our Web site those organizations that are both ONC-ACBs and NVLAP-
accredited testing labs. We also suspect that such an organization will 
publicize its status as an ONC-ACB and NVLAP-accredited testing lab in 
an effort to increase market share.

N. Concept of ``Self-Developed''

    In the Proposed Rule, we interpreted the HIT Policy Committee's use 
of the word ``self-developed'' to mean a Complete EHR or EHR Module 
that has been designed, modified, or created by, or under contract for, 
a person or entity that will assume the total costs for its testing and 
certification and will be a primary user of the Complete EHR or EHR 
Module. We noted that self-developed Complete EHRs and EHR Modules 
could include brand new Complete EHRs or EHR Modules developed by a 
health care provider or their contractor. We further noted that ``self-
developed'' could also include a previously purchased Complete EHR or 
EHR Module that is subsequently modified by the health care provider or 
their contractor and where such modifications are made to capabilities 
addressed by certification criteria adopted by the Secretary. We 
specifically stated that we would limit the scope of ``modification'' 
to only those capabilities for which the Secretary has adopted 
certification criteria because other capabilities (e.g., a different 
graphical user interface (GUI)) would not affect the underlying 
capabilities a Complete EHR or EHR Module would need to include in 
order to be tested and certified. Accordingly, we stated that we would 
only refer to the Complete EHR or EHR Module as ``self-developed'' if 
the health care provider paid the total costs to have the Complete EHR 
or EHR Module tested and certified.
    Comments. Multiple hospitals and hospital associations requested 
that we clarify the definition of ``self-developed'' to include an 
indication of the extent to which modifications may be made to 
previously certified Complete EHRs or EHR Modules without requiring a 
Complete EHR or EHR Module to be certified as ``self-developed.'' The 
commenters noted that we have clearly stated that eligible 
professionals and eligible hospitals bear full responsibility for 
making certified EHR Modules work together. Therefore, the commenters 
contended that providers must be permitted to make necessary 
modifications to certified EHR Modules in order to fulfill that 
responsibility. The commenters stated that often there is a need for 
custom configurations or settings within the parameters of certified 
EHRs, including modifications that may be necessary to ensure that the 
EHR works properly when implemented within an organization's entire HIT 
environment. The commenters further stated that such modifications may 
affect, or even enhance, the capabilities addressed by the 
certification criteria by providing additional and specific decision-
support functions or allowing for additional quality improvement 
activities. The commenters asserted that as long as the Complete EHR or 
EHR Module can still perform the function(s) for which it was 
originally certified, such modifications should not trigger a

[[Page 1301]]

requirement for the Complete EHR or EHR Module to be certified as self-
developed, even if the changes affect the capabilities addressed by the 
certification criteria.
    The commenters stated that clarity was needed due to the 
substantial resources that will be required for certification of self-
developed systems. In addition, commenters stated that, for legal 
compliance purposes, clarity will enable providers to be confident in 
the attestations they submit to Federal and State agencies regarding 
the certification status of the EHR technology they use.
    Response. As we stated in the Temporary Certification Program final 
rule, we understand the unique needs and requirements of eligible 
professionals and eligible hospitals with respect to the successful 
implementation and integration of HIT into operational environments. We 
provided a description of the term ``self-developed'' in the Proposed 
Rule's preamble for two main reasons. First, in order to provide 
greater clarity for stakeholders regarding who would be responsible for 
the costs associated with certification, and second, to clearly 
differentiate in our regulatory impact analysis those Complete EHRs and 
EHR Modules that would be certified once and most likely sold to many 
eligible professionals and eligible hospitals from those that would be 
certified once and used primarily by the person or entity who paid for 
the testing and certification. We believe that many commenters were not 
concerned about the fact that brand new, ``built from scratch'' self-
developed Complete EHRs and EHR Modules would need to be certified. 
Rather, it appeared that commenters were concerned about whether any 
modification to a Complete EHR or EHR Module that had been certified 
already, including those modifications that would be enhancements or 
required to integrate several EHR Modules, would compromise the 
technology's certification or certifications and consequently require 
the eligible professional or eligible hospital to seek a new 
certification because the EHR technology would be considered self-
developed. We believe this concern stems from the following statement 
we made in the preamble of the Proposed Rule:

    ``Self-developed Complete EHRs and EHR Modules could include 
brand new Complete EHRs or EHR Modules developed by a health care 
provider or their contractor. It could also include a previously 
purchased Complete EHR or EHR Module which is subsequently modified 
by the health care provider or their contractor and where such 
modifications are made to capabilities addressed by certification 
criteria adopted by the Secretary. We limit the scope of 
``modification'' to only those capabilities for which the Secretary 
has adopted certification criteria because other capabilities (e.g., 
a different graphical user interface (GUI)) would not affect the 
underlying capabilities a Complete EHR or EHR Module would need to 
include in order to be tested and certified.''

    In response to these concerns, we offer further clarification of 
the intent of our statements. We agree with commenters that not every 
modification would or should require a previously certified Complete 
EHR or EHR Module to be certified again as self-developed. We provided 
an example in the Proposed Rule, quoted above, regarding modifications 
that would not affect any of the capabilities addressed by the 
certification criteria adopted by the Secretary. In the Temporary 
Certification Program final rule, we acknowledged that a certified 
Complete EHR or EHR Module may not automatically meet a health care 
provider's needs when it is implemented in an operational environment. 
We also cautioned eligible professionals and eligible hospitals in the 
HIT Standards and Certification Criteria interim final rule that, if 
they choose to use EHR Modules to meet the definition of Certified EHR 
Technology, they alone would be responsible for properly configuring 
multiple EHR Modules in order to make them work together. Given that 
many of the certification criteria adopted by the Secretary express 
minimum capabilities, which may be added to or enhanced by eligible 
professionals and eligible hospitals to meet their health care delivery 
needs (e.g., multiple rules could be added to the clinical decision 
support capability), we believe it is unrealistic to expect that the 
capabilities included within adopted certification criteria applicable 
to a Complete EHR or EHR Module will not be modified in some cases. As 
a result, we believe it is possible for an eligible professional or 
eligible hospital to modify a Complete EHR or EHR Module's capabilities 
for which certification criteria have been adopted without compromising 
the Complete EHR or EHR Module's certification. Stated differently, an 
eligible professional or eligible hospital's modifications to a 
certified Complete EHR or EHR Module would not automatically make the 
Complete EHR or EHR Module ``self-developed'' and consequently require 
the eligible professional or eligible hospital to obtain a new 
certification for the modified product. While we cannot review or 
address in this final rule every potential modification to determine 
whether it could possibly compromise a Complete EHR or EHR Module's 
certification, we strongly urge eligible professionals and eligible 
hospitals to consider the following. Certification is meant to provide 
assurance that a Complete EHR or EHR Module will perform according to 
the certification criteria to which it was tested and certified. Any 
modification to a Complete EHR or EHR Module after it has been 
certified has the potential to adversely affect the capabilities for 
which certification criteria have been adopted such that the Complete 
EHR or EHR Module no longer performs as it did when it was tested and 
certified, which in turn may compromise an eligible professional or 
eligible hospital's ability to achieve meaningful use. If an eligible 
professional or eligible hospital wants complete assurance that a 
Complete EHR or EHR Module's capabilities for which certification 
criteria have been adopted were not adversely affected by modifications 
that were made post-certification, they may choose to have the Complete 
EHR or EHR Module retested and recertified. Additionally, any post-
certification modifications that adversely affect a Complete EHR or EHR 
Module's capabilities for which certification criteria have been 
adopted may be identified through surveillance conducted by an ONC-ACB.

O. Validity of Complete EHR and EHR Module Certification and Expiration 
of Certified Status

    In the Proposed Rule, we discussed the validity of ``certified 
status'' of Complete EHRs and EHR Modules, as well as the expiration of 
that status as it related to the definition of Certified EHR 
Technology. We stated that certification represented ``a snapshot, a 
fixed point in time, where it has been confirmed that a Complete EHR or 
EHR Module has met all applicable certification criteria adopted by the 
Secretary.'' We went on to say that as the Secretary adopts new or 
modified certification criteria, the previously adopted set of 
certification criteria would no longer constitute all of the applicable 
certification criteria to which a Complete EHR or EHR Module would need 
to be tested and certified. Thus, we clarified that after the Secretary 
has adopted new or modified certification criteria, a previously 
certified Complete EHR or EHR Module's certification would no longer be 
valid for purposes of meeting the definition of Certified EHR 
Technology. In other words, because new or modified certification 
criteria had been adopted, previously

[[Page 1302]]

issued certifications would no longer indicate that a Complete EHR or 
EHR Module possessed all of the capabilities necessary to support an 
eligible professional's or eligible hospital's achievement of 
meaningful use. Accordingly, we noted that Complete EHRs and EHR 
Modules that had been certified to the previous set of adopted 
certification criteria would no longer constitute ``Certified EHR 
Technology.''
    We also discussed that the planned two-year schedule for updates to 
meaningful use objectives and measures and correlated certification 
criteria created a natural expiration with respect to the validity of a 
previously certified Complete EHR's or EHR Module's certified status 
and its continued ability to be used to meet the definition of 
Certified EHR Technology. We stated that after the Secretary has 
adopted new or modified certification criteria, previously certified 
Complete EHRs and EHR Modules must be recertified in order to continue 
to qualify as Certified EHR Technology.
    With respect to EHR Modules, we noted that there could be 
situations where measures associated with a meaningful use objective 
may change, but the capability a certified EHR Module would need to 
provide would not change. As a result, we stated that it may be 
impracticable or unnecessary for the EHR Module to be re-certified. 
Therefore, we requested public comment on whether there should be 
circumstances where EHR Modules should not have to be re-certified.
    We clarified that regardless of the year and meaningful use stage 
at which an eligible professional or eligible hospital enters the 
Medicare or Medicaid EHR Incentive Programs, the Certified EHR 
Technology that would need to be used must include the capabilities 
necessary to meet the most current set of certification criteria 
adopted by the Secretary at 45 CFR 170 subpart C in order to satisfy 
the definition of Certified EHR Technology. Finally, we asked for 
public comment on the best way to assist eligible professionals and 
eligible hospitals that begin meaningful use in 2013 or 2014 at Stage 1 
in identifying Complete EHRs and/or EHR Modules that have been 
certified to the most current set of adopted certification criteria and 
therefore could be used to meet the definition of Certified EHR 
Technology.
    Comments. Several commenters disagreed with our position that 
Complete EHRs and EHR Modules need to include the capabilities 
necessary to meet the most current set of certification criteria 
adopted by the Secretary at 45 CFR 170 subpart C in order to satisfy 
the definition of Certified EHR Technology. Other commenters agreed and 
contended that Certified EHR Technology should always be as up-to-date 
and as current as possible. Of those commenters that disagreed, their 
concerns focused on two areas: the validity/expiration of certified 
status; and the effect on eligible professionals and eligible hospitals 
who adopt Certified EHR Technology in the year before we anticipate 
updating adopted standards, implementation specifications, and 
certification criteria for a future stage of meaningful use.
    Commenters asserted that some certification criteria were unlikely 
to change between meaningful use stages and that a Complete EHR or EHR 
Module's certification should remain valid and not expire until the 
Secretary has adopted updated certification criteria. These commenters 
requested that ONC only make changes to certification criteria on a 
cyclical basis and only when necessary for meaningful use or to advance 
interoperability.
    A number of commenters expressed concerns about our position and 
contended that it would require eligible professionals and eligible 
hospitals who adopt Certified EHR Technology in 2012 (and attempt 
meaningful use Stage 1 in 2012) to upgrade their Certified EHR 
Technology twice in two years in order to continue to be eligible for 
meaningful use incentives during 2013 when they would still only have 
to meet meaningful use Stage 1 (according to the staggered approach for 
meaningful use stages that was proposed by CMS). Some of these 
commenters viewed this as a penalty and disagreed with our position 
that eligible professionals and eligible hospitals should be required 
to use Certified EHR Technology that had been certified to the most 
recently adopted certification criteria. Additionally, these commenters 
stated that it is not in the best interest of eligible professionals 
and eligible hospitals to require that they use Certified EHR 
Technology that includes more advanced capabilities than are necessary 
to qualify for the meaningful use stage that they are attempting to 
meet. Finally, one commenter requested that we offer a graphical 
depiction to more clearly convey our position.
    Response. In the Temporary Certification Program final rule, we 
discussed the concept of validity as it relates to the definition of 
Certified EHR Technology and the certifications that are issued to 
Complete EHRs and EHR Modules. We believe it is necessary to clarify 
that discussion in this final rule. We explained that an eligible 
professional or eligible hospital cannot assert that a certification 
issued to a particular Complete EHR or EHR Module is valid for purposes 
of satisfying the definition of Certified EHR Technology if the 
certification criteria (including the standards and implementation 
specifications referenced by the criteria) that are related to a 
particular capability have been modified. In other words, if the 
applicable certification criteria have been altered or changed, then an 
eligible professional or eligible hospital can no longer represent that 
a certified Complete EHR or combination of certified EHR Modules 
continues to constitute Certified EHR Technology based on the 
certifications that were previously issued.
    As mentioned in both the HIT Standards and Certification Criteria 
final rule and the Medicare and Medicaid EHR Incentive Programs final 
rule, it is anticipated that the requirements for meaningful use will 
be adjusted every two years. We expect the Secretary will adopt 
certification criteria through rulemaking every two years in 
correlation with the changes to the meaningful use requirements. We 
also recognize, however, that circumstances may necessitate a deviation 
from the expected two-year rulemaking cycle, such as with the interim 
final rule published on October 13, 2010 (75 FR 62686) to remove the 
previously adopted implementation specifications related to public 
health surveillance. Future rulemakings could potentially include the 
adoption of new and revised certification criteria in addition to those 
already adopted. We consider new certification criteria to be those 
that specify capabilities for which the Secretary has not previously 
adopted certification criteria. New certification criteria would also 
include certification criteria that were previously adopted for 
Complete EHRs or EHR Modules designed for a specific setting and are 
subsequently adopted for Complete EHRs or EHR Modules designed for a 
different setting (for example, if the Secretary previously adopted a 
certification criterion at Sec.  170.304 only for Complete EHRs or EHR 
Modules designed for an ambulatory setting and then subsequently adopts 
that certification criterion at Sec.  170.306 for Complete EHRs or EHR 
Modules designed for an inpatient setting). We consider revised 
certification criteria to be certification criteria previously adopted 
by the Secretary that are modified to add, remove, or otherwise alter 
the specified capabilities and/or the standard(s) or implementation 
specification(s) referred to by the

[[Page 1303]]

certification criteria. Revised certification criteria would also 
include certification criteria that were previously adopted as optional 
but are subsequently adopted as mandatory (for example, if the optional 
criterion at Sec.  170.302(w) is subsequently adopted as a mandatory 
criterion).
    Only when eligible professionals or eligible hospitals are in 
possession of a Complete EHR or EHR Module that has been certified to 
all of the applicable certification criteria, including new and revised 
certification criteria, that have been adopted by the Secretary at 
subpart C of part 170, will they be able to assert that they possess a 
Complete EHR or EHR Module with a certification that would be 
considered valid for purposes of satisfying the definition of Certified 
EHR Technology. For example, based on our expectation that the 
meaningful use requirements will be modified every two years, we 
anticipate that the Secretary will adopt certification criteria during 
2012 for the 2013 and 2014 payment years of the Medicare and Medicaid 
EHR Incentive Programs (referenced in Table 1 below). A Complete EHR 
that was previously certified in 2010 to the certification criteria 
adopted for the 2011 and 2012 payment years must be certified again as 
compliant with all of the applicable certification criteria adopted for 
the 2013 and 2014 payment years in order for that Complete EHR to 
continue to meet the definition of Certified EHR Technology. As we 
discuss in the next section of this preamble (P. Differential or Gap 
Certification), the permanent certification program will include the 
option of ``gap certification'' in an effort to provide a more 
efficient and streamlined process for the certification of previously 
certified Complete EHRs and EHR Modules.
    We explained in the HIT Standards and Certification Criteria final 
rule that additional flexibility and specificity can be introduced into 
future cycles of rulemaking through the adoption and designation of 
``optional'' standards, implementation specifications, and 
certification criteria. We acknowledged that these would be voluntary 
and would not be required for testing and certifying a Complete EHR or 
EHR Module, although they could help to prepare the HIT industry for 
future mandatory certification requirements. Thus, in certain 
instances, the Secretary may adopt through rulemaking additional 
standards and/or implementation specifications that would be referenced 
as optional by a previously adopted certification criterion or 
criteria, in an effort to provide EHR technology developers more 
flexibility with respect to what is permitted to achieve certification 
for a Complete EHR or EHR Module. We emphasize that this would not 
affect the validity of certifications that were previously issued to 
Complete EHRs and EHR Modules. In other words, a previously certified 
Complete EHR or EHR Module would not be required to be certified 
according to new optional standard(s) or implementation specifications 
in order for it to continue to be used to meet the definition of 
Certified EHR Technology.
    As we stated in the Proposed Rule, if a previously certified 
Complete EHR is not tested and certified as compliant with all of the 
applicable certification criteria adopted by the Secretary, it would 
not lose its certification, but it also would no longer satisfy the 
definition of Certified EHR Technology. Many commenters acknowledged 
that especially in situations where certification criteria have been 
adopted to improve the interoperability of EHR technology, 
certification to new and revised certification criteria would be needed 
and justified in order to meet the definition of Certified EHR 
Technology. With respect to the validity of a Complete EHR or EHR 
Module's certification, we ask commenters to consider how they would 
expect to meet the requirements of a subsequent stage of meaningful use 
without the technical capabilities necessary to do so. A Complete EHR 
or EHR Module's certification is only as good as the capabilities that 
can be associated with that certification. If the Secretary adopts new 
or revised certification criteria, Complete EHRs and likely many EHR 
Modules may no longer provide all of the capabilities that would be 
necessary to support an eligible professional's or eligible hospital's 
attempt to meet the requirements of a particular stage of meaningful 
use.
    In its final rule, CMS indicated that ``[t]he stages of criteria of 
meaningful use and how they are demonstrated are described further in 
this final rule and will be updated in subsequent rulemaking to reflect 
advances in HIT products and infrastructure. We note that such future 
rulemaking might also include updates to the Stage 1 criteria.'' 75 FR 
44323 (emphasis added). We believe that the commenters who expressed 
concerns and objected to our discussion of the expiration/validity of a 
Complete EHR or EHR Module's certified status did not account for the 
possibility that the requirements for an eligible professional or 
eligible hospital to meet meaningful use Stage 1 in 2013 or 2014 could 
be different and possibly more demanding than they were for meaningful 
use Stage 1 in 2012. Contrary to some commenters' assumptions and 
consistent with the statement by CMS quoted above, it is possible that 
in a subsequent rulemaking to establish the objectives and measures for 
meaningful use Stage 2, CMS could change what is required to 
successfully demonstrate meaningful use Stage 1 in 2013. Consequently, 
such changes could include additional requirements that are based on 
advances in HIT and go beyond the requirements that have been finalized 
by CMS for meaningful use Stage 1 in 2011 and 2012. Therefore, an 
eligible professional or eligible hospital who demonstrates meaningful 
use for the first time in 2012 may potentially need Certified EHR 
Technology with new or additional capabilities in order to satisfy the 
meaningful use Stage 1 requirements in 2013.
    Because the HITECH Act requires eligible professionals and eligible 
hospitals to use Certified EHR Technology in order to qualify for 
incentive payments under the Medicare and Medicaid EHR Incentive 
Programs, we reaffirm our position expressed in the Proposed Rule. 
Regardless of the year and meaningful use stage at which eligible 
professionals or eligible hospitals enter the Medicare or Medicaid EHR 
Incentive Programs, they must use Certified EHR Technology that has 
been certified to all of the applicable certification criteria adopted 
by the Secretary at subpart C of part 170, which includes new and 
revised certification criteria that have been adopted since their EHR 
technology was previously certified. We believe this position takes 
into account the best interests of eligible professionals and eligible 
hospitals because those who implement EHR technology that meets the 
definition of Certified EHR Technology will have the assurance that 
their EHR technology includes the requisite capabilities to support 
their attempts to demonstrate meaningful use. Moreover, our position 
ensures that all Certified EHR Technology will have been tested and 
certified to the same standards and implementation specifications and 
provide the same level of interoperability, which would not be the case 
if we were to permit different variations of Certified EHR Technology 
to exist.
    To further address concerns raised by the commenters, we clarify as 
we did in the Temporary Certification Program final rule that if the 
temporary certification program sunsets on December 31, 2011, and the 
permanent certification program is fully constituted at the start of 
2012, Complete EHRs and

[[Page 1304]]

EHR Modules that were previously certified by ONC-ATCBs to the 
certification criteria adopted by the Secretary for the 2011/2012 
payment years will not need to be recertified as having met the 
certification criteria for those years. In other words, the fact that 
the permanent certification program has replaced the temporary 
certification program will not automatically render certifications that 
were issued by ONC-ATCBs pursuant to the certification criteria adopted 
for the 2011/2012 payment years invalid for the purpose of meeting the 
definition of Certified EHR Technology. However, once the permanent 
certification program is fully constituted and after the Secretary has 
adopted new or revised certification criteria (which we expect will 
occur in 2012, based on the two-year rulemaking cycle), Complete EHRs 
and EHR Modules that were previously certified under the temporary 
certification program by ONC-ATCBs must be certified by an ONC-ACB.
    We provide the following illustration overlaid on ``Table 1--Stage 
of Meaningful Use Criteria by Payment Year'' from the Medicare and 
Medicaid EHR Incentive Programs final rule (75 FR 44323) to more 
clearly convey the discussion above. This illustration would also be 
applicable to the Medicaid program.
---------------------------------------------------------------------------

    \2\ If the permanent certification program is fully constituted 
and the temporary certification program sunsets on December 31, 
2011, all new requests made after that date for certification of 
Complete EHRs or EHR Modules to the 2011/2012 certification criteria 
will be processed by ONC-ACBs.

                            Table 1--Stage of Meaningful Use Criteria by Payment Year
----------------------------------------------------------------------------------------------------------------
                                                                   Payment Year
       First Payment Year       --------------------------------------------------------------------------------
                                        2011                2012                2013                2014
----------------------------------------------------------------------------------------------------------------
2011...........................  Stage 1...........  Stage 1...........  Stage 2..........  Stage 2.
2012...........................  ..................  Stage 1...........  Stage 1..........  Stage 2.
2013...........................  ..................  ..................  Stage 1..........  Stage 1.
2014...........................  ..................  ..................  .................  Stage 1.
----------------------------------------------------------------------------------------------------------------
                                 Complete EHRs and EHR Modules
                                  certified by ONC-ATCBs or ONC-ACBs
                                  \2\ to all of the applicable
                                  certification criteria adopted for
                                  the 2011 & 2012 payment years meet
                                  the definition of Certified EHR
                                  Technology.
                                 Complete EHRs and EHR Modules
                                  certified by ONC-ACBs to all of the
                                  applicable certification criteria
                                  adopted for the 2013 & 2014 payment
                                  years meet the definition of
                                  Certified EHR Technology.
----------------------------------------------------------------------------------------------------------------

    Comments. In response to our question about how to identify those 
Complete EHRs and/or EHR Modules that have been certified to the most 
current set of adopted certification criteria (and thus would 
constitute Certified EHR Technology), several commenters offered 
suggestions regarding ``labeling'' conventions for Complete EHRs and 
EHR Modules. Overall, commenters indicated that specific ``labeling'' 
parameters would help clarify whether a Complete EHR or EHR Module's 
certification is current. These commenters offered a variety of 
suggested techniques, including identifying Complete EHRs and EHR 
Modules according to: the applicable meaningful use stage they could be 
used for; the month and year they had been certified; and the year 
associated with the most current set of adopted standards, 
implementation specifications, and certification criteria. 
Additionally, in light of the EHR Module ``pre-coordinated, integrated 
bundle'' concept we proposed with respect to the certification of EHR 
Modules to the adopted privacy and security certification criteria, one 
commenter recommended that we assign specific ``labeling'' constraints 
to certifications issued to pre-coordinated, integrated bundles of EHR 
Modules. Another comment suggested ``labeling'' constraints be assigned 
when a Complete EHR or EHR Module had been certified at an eligible 
professional or eligible hospital's site (e.g., at the hospital where 
the Complete EHR is deployed).
    Response. We agree with the commenters who requested more specific 
requirements surrounding how a Complete EHR or EHR Module's certified 
status should be represented and communicated. We believe more 
specificity will assist eligible professionals and eligible hospitals 
with their purchasing decisions by helping them to identify those 
Complete EHRs and EHR Modules that have a current and valid 
certification issued by an ONC-ACB. As previously discussed, the ONC-AA 
must verify that ONC-ACBs conform to Guide 65 at a minimum, which 
includes in section 14 a requirement that certification bodies (i.e., 
ONC-ACBs) exercise control over the use and display of ``certificates'' 
and marks of conformity. To ensure consistency in how the certified 
status of a Complete EHR or EHR Module is represented and communicated, 
and in response to those comments, we are adding a new principle to the 
Principles of Proper Conduct for ONC-ACBs at Sec.  170.523(k). We added 
a similar new Principle of Proper Conduct for ONC-ATCBs in the 
Temporary Certification Program final rule. The new Principle of Proper 
Conduct requires ONC-ACBs to ensure adherence to the following 
requirements when issuing a certification to Complete EHRs and/or EHR 
Modules:
    (1) A Complete EHR or EHR Module developer must conspicuously 
include the following on its Web site and in all marketing materials, 
communications statements, and other assertions related to the Complete 
EHR or EHR Module's certification:
    (i) ``This [Complete EHR or EHR Module] is 20[XX]/20[XX] compliant 
and has been certified by an ONC-ACB in accordance with the applicable 
certification criteria adopted by the Secretary of Health and Human 
Services. This certification does not represent an endorsement by the 
U.S. Department of Health and Human Services or guarantee the receipt 
of incentive payments.''; and
    (ii) The information an ONC-ACB is required to report to the 
National Coordinator under paragraph (f) of this section for the 
specific Complete EHR or EHR Module at issue;
    (2) A certification issued to a pre-coordinated, integrated bundle 
of EHR

[[Page 1305]]

Modules shall be treated the same as a certification issued to a 
Complete EHR for the purposes of paragraph (k)(1) of this section 
except that the certification must also indicate each EHR Module that 
is included in the bundle; and
    (3) A certification issued to a Complete EHR or EHR Module based 
solely on the applicable certification criteria adopted by the 
Secretary at subpart C of this part must be separate and distinct from 
any other certification(s) based on other criteria or requirements.
    This new Principle of Proper Conduct is based on our assumption 
that the Secretary will adopt certification criteria through rulemaking 
every two years in correlation with the expected modifications to the 
meaningful use requirements. With respect to the requirement in Sec.  
170.523(k)(1)(i) regarding ``20[XX]/20[XX] compliant,'' we expect ONC-
ACBs will indicate the years ``2011/2012 compliant'' for all Complete 
EHRs and EHR Modules that are certified to the certification criteria 
adopted by the Secretary for the 2011 and 2012 payment years of the 
Medicare and Medicaid EHR Incentive Programs. Continuing our assumption 
of a two-year rulemaking cycle, we expect ONC-ACBs to follow this 
convention as the Secretary adopts certification criteria for 
subsequent payment years. For example, if the Secretary adopts 
certification criteria as expected in 2012 for the 2013 and 2014 
payment years, ONC-ACBs would indicate ``2013/2014 compliant.''
    Given the clarification we provided as to when a Complete EHR or 
EHR Module's certification will be considered valid for purposes of 
meeting the definition of Certified EHR Technology, we believe it would 
be inappropriate and misleading to adopt an identification requirement 
that is solely associated with the meaningful use stages. We also 
believe it would be inappropriate to identify a Complete EHR or EHR 
Module based on whether its certification could be attributed to a 
particular entity at a particular location. While unlikely, we do not 
want to presume that such a certified Complete EHR or EHR Module would 
not be useful to another eligible professional or eligible hospital.
    We do, however, agree with the commenter who suggested the specific 
constraint for a pre-coordinated, integrated bundle of EHR Modules. As 
we explained, we would expect that EHR Module developer(s) will have 
addressed any issues related to the compatibility of EHR Modules that 
make up a pre-coordinated, integrated bundle before the bundle is 
presented for certification pursuant to Sec.  170.550(e)(1). The pre-
coordinated, integrated bundle of EHR Modules is greater than the sum 
of the individual EHR Modules that make up the bundle, and for that 
reason, we clarify that individual EHR Modules that are certified as 
part of a pre-coordinated, integrated bundle would not each separately 
inherit a certification just because they had been certified as part of 
a bundle. For example, if EHR Modules A, B, C, and D are certified as a 
pre-coordinated, integrated bundle, EHR Module C would not on its own 
be certified just by virtue of the fact that it was part of a certified 
pre-coordinated, integrated bundle. If an EHR Module developer wanted 
to make EHR Module C available for use by eligible professionals and 
eligible hospitals as a single certified EHR Module independent of and 
separate from the bundle, then it must have EHR Module C separately 
certified by an ONC-ACB.
    As we discussed in the Proposed Rule, there may be situations where 
the measures associated with a meaningful use objective may change as a 
result of subsequent rulemaking, but the capability a certified EHR 
Module would need to provide would not change. As a hypothetical 
example, during the expected 2012 rulemaking cycle, the threshold of 
the meaningful use Stage 1 measure associated with the ``record patient 
demographics'' objective could be increased from 50% to 75%. When the 
Secretary adopts certification criteria for the 2013/2014 payment 
years, however, the certification criterion or criteria that are 
applicable to an EHR Module designed to record patient demographics 
could potentially remain unchanged.
    We recognize it may not be practical or beneficial for the EHR 
Module in this example to be certified again, where the certification 
criterion or criteria to which it was previously certified have not 
been revised and no new certification criteria have been adopted that 
are applicable to it. However, in accordance with Sec.  170.423(k)(1) 
or Sec.  170.523(k)(1), the ONC-ATCB or ONC-ACB that certified the EHR 
Module would have required the EHR Module developer to include certain 
information on its Web site and in other materials related to the 
payment years associated with the certification criteria to which the 
EHR Module was previously certified. To ensure that the information 
required by Sec.  170.523(k)(1)(i) remains accurate and reflects the 
correct payment years, we will permit ONC-ACBs to provide updated 
certifications to previously certified EHR Modules.
    We define ``providing or provide an updated certification'' as the 
action taken by an ONC-ACB to ensure that the developer of a previously 
certified EHR Module shall update the information required by Sec.  
170.523(k)(1)(i), after the ONC-ACB has verified that the certification 
criterion or criteria to which the EHR Module was previously certified 
have not been revised and that no new certification criteria adopted 
for privacy and security are applicable to the EHR Module. To verify 
that the certification criterion or criteria have not been revised, an 
ONC-ACB would compare the certification criterion or criteria to which 
the EHR Module was previously certified with all of the certification 
criteria adopted by the Secretary for the relevant payment years (in 
the example above, the 2013/2014 payment years). To verify whether new 
certification criteria adopted for privacy and security are applicable 
to the EHR Module, an ONC-ACB would complete the analysis described in 
Sec.  170.550(e)(2) to determine, upon a request to provide an updated 
certification, whether the EHR Module developer has demonstrated and 
provided documentation that such certification criteria are 
inapplicable or that it would be technically infeasible for the EHR 
Module to be certified in accordance with such certification criteria.
    We believe that providing updated certifications is a pragmatic 
approach for the treatment of previously certified EHR Modules and that 
it is consistent with requirements specified in Guide 65, section 12 
(Decision on certification), which requires certification bodies to 
issue certifications specifying the scope of the certification, the 
effective date of the certification, and any applicable terms. We also 
believe that this approach is consistent with Guide 65, section 14 (Use 
of licenses, certificates and marks of conformity), which requires the 
certification body to exercise proper control over the use and display 
of certificates and marks of conformity, including addressing incorrect 
references to the certification system or misleading use of 
certificates or marks. The information required by Sec.  170.523(k)(1) 
is intended to assist eligible professionals and eligible hospitals in 
identifying specific EHR technology that could be purchased and adopted 
for the purpose of meeting the definition of Certified EHR Technology 
and attempting to demonstrate meaningful use. ONC-ACBs must be able to 
ensure that this information is kept current and accurate if it is to 
be

[[Page 1306]]

helpful to prospective purchasers of EHR technology and to instill 
confidence in the certifications issued under the permanent 
certification program. We are defining ``providing or provide an 
updated certification'' in Sec.  170.502 and are adding a new provision 
to Sec.  170.550, designated as paragraph (d), to permit ONC-ACBs to 
provide updated certifications to previously certified EHR Module(s).
    ONC-ACBs may choose to provide updated certifications but are not 
required to do so, because we recognize situations could exist where an 
ONC-ACB is not comfortable providing an updated certification. For 
instance, an ONC-ACB may not want to provide an updated certification 
if it did not issue the original certification to the EHR Module or if 
there has been an extended period of time since the EHR Module was 
tested and/or certified. If an ONC-ACB elects not to provide updated 
certifications, an EHR Module developer may choose to have its EHR 
Module recertified and/or retested, even though the certification 
criterion or criteria to which the EHR Module was previously certified 
have not been revised and no new certification criteria have been 
adopted that are applicable to the EHR Module. In order to make the 
certification process as efficient as possible in this scenario, we 
will permit ONC-ACBs to rely on prior testing completed by an ONC-ATCB. 
Accordingly, we are revising Sec.  170.523(h) to permit ONC-ACBs to 
rely on the results of testing performed by ONC-ATCBs for the purpose 
of certifying a previously certified EHR Module(s) if the certification 
criterion or criteria to which the EHR Module(s) was previously 
certified have not been revised and no new certification criteria are 
applicable to the EHR Module(s).
    Comments. Several commenters requested that we clarify whether each 
updated version of a Complete EHR or EHR Module would need to be 
recertified in order for its certification to remain valid, and whether 
there would be a mechanism available to accommodate routine changes and 
product maintenance without the need for full recertification of each 
updated version of a previously certified Complete EHR or EHR Module. 
Some of these commenters stressed that they provide bug-fixes and other 
maintenance upgrades to customers on a regular basis and that those 
versions are normally denoted by a new ``dot release'' (e.g., version 
7.1.1 when 7.1 received certification). Another commenter requested 
that we consider the impact of potentially more dynamic software 
development/release models, such as those related to cloud computing 
and software-as-a-service, that may not fit a traditional (major/minor/
maintenance) release schedule. The commenter indicated that there may 
be more frequent software updates for these types of EHR technologies.
    Response. We understand that Complete EHR and EHR Module developers 
will conduct routine maintenance. We also recognize that at times 
Complete EHR and EHR Module developers will provide new or modified 
capabilities either to make the Complete EHR or EHR Module perform more 
efficiently and/or to improve user experiences related to certain 
functionality (e.g., a new graphical user interface (GUI)). Our main 
concern is whether these changes adversely affect the capabilities of a 
Complete EHR or EHR Module that has already been certified and whether 
the changes are such that the Complete EHR or EHR Module would no 
longer support an eligible professional or eligible hospital's 
achievement of meaningful use. Accordingly, we clarify that a 
previously certified Complete EHR or EHR Module may be updated for 
routine maintenance or to include new or modified capabilities without 
the need for recertification, and such changes may affect capabilities 
that are related or unrelated to the certification criteria adopted by 
the Secretary.\3\ However, we do not believe that it would be wise to 
simply permit a Complete EHR or EHR Module developer to claim without 
any verification that the routine maintenance or new/modified 
capabilities included in a newer version do not adversely affect the 
proper functioning of the capabilities for which certification was 
previously granted. An ONC-ACB should, at a minimum, review an 
attestation submitted by a Complete EHR or EHR Module developer 
explaining the changes that were made and the reasons for those 
changes, as well as other information and supporting documentation that 
would be necessary for the ONC-ACB to evaluate the potential effects of 
the changes on previously certified capabilities. We believe this 
process is consistent with the requirements placed on certification 
bodies by Guide 65, sections 4.6.2 (related to conditions and 
procedures for granting, maintaining, extending, suspending and 
withdrawing certification) and 12.4 (related to decisions on 
certifications).
---------------------------------------------------------------------------

    \3\ We understand that Complete EHR and EHR Module developers 
typically consider a ``minor version release'' to be, for example, a 
version number change from 3.0 to 3.1 and consider a ``major version 
release'' to be, for example, a version number change from 4.0 to 
5.0. In providing for this flexibility, we do not presume the 
version numbering schema that a Complete EHR or EHR Module developer 
may choose to utilize. As a result, we do not preclude a Complete 
EHR or EHR Module developer from submitting an attestation to an 
ONC-ACB for a Complete EHR or EHR Module whose version number may 
represent a minor or major version change.
---------------------------------------------------------------------------

    As a result, we are adding a new provision to Sec.  170.545, 
designated as paragraph (d), that requires an ONC-ACB to accept 
requests for a newer version of a previously certified Complete EHR to 
inherit the certified status of the previously certified Complete EHR 
without requiring the newer version to be recertified. We are also 
adding a similar provision to Sec.  170.550, designated as paragraph 
(f), that requires an ONC-ACB to accept requests for a newer version of 
a previously certified EHR Module(s) to inherit the certified status of 
the previously certified EHR Module(s) without requiring the newer 
version to be recertified. However, consistent with both of these new 
provisions, the developer of the Complete EHR or EHR Module(s), must 
submit an attestation as described above in the form and format 
specified by the ONC-ACB that the newer version does not adversely 
affect any capabilities for which certification criteria have been 
adopted. After reviewing the attestation, the ONC-ACB must determine 
whether the Complete EHR's or EHR Module's capabilities, for which 
certification criteria have been adopted, have been adversely affected 
(which would consequently require the newer version to be recertified), 
or whether to grant a certification to the newer version of the 
previously certified Complete EHR or EHR Module that is based on the 
previous certification. In determining whether the newer version should 
be recertified, the ONC-ACB may also determine whether retesting is 
necessary.
    If the ONC-ACB issues a certification to a newer version of a 
previously certified Complete EHR or EHR Module, the ONC-ACB must 
include this certification in its weekly report to the National 
Coordinator. We believe that for the purposes of associating a 
certification with a given EHR technology, this policy is appropriate 
regardless of the software development/release approach employed by an 
EHR technology developer. As we have stated before, certification 
represents a snapshot, a fixed point in time, where it has been 
confirmed (in this case by an ONC-ACB) that a Complete EHR or EHR 
Module has met all applicable certification criteria adopted by the 
Secretary. Thus, if a different version of a Complete EHR or EHR Module 
is made available and the EHR technology

[[Page 1307]]

developer seeks to have this version inherit a prior version's 
certification, the prior version's certification needs to be formally 
associated with this newer version and subsequently reported to the 
National Coordinator. Without this association, an EHR technology 
developer would not be able to assert that the updated or modified EHR 
technology was ``certified,'' nor would eligible professionals or 
eligible hospitals be able to verify on ONC's Certified HIT Products 
List (CHPL) that the EHR technology is certified.
    Aside from the requirements discussed above, we do not specify the 
fees or any other processes that an ONC-ACB must follow before granting 
certified status to a newer version of a previously certified Complete 
EHR or EHR Module based on the submitted attestation. We encourage ONC-
ACBs to develop streamlined approaches for attestations in order to 
accommodate different software release models and schedules.

P. Differential or Gap Certification

    We stated in the Proposed Rule that, after Complete EHRs and EHR 
Modules have been certified as being in compliance with the 
certification criteria associated with meaningful use Stage 1, it may 
benefit both Complete EHR and EHR Module developers as well as eligible 
professionals and eligible hospitals if some form of differential 
certification were available. We described differential certification 
as the certification of Complete EHRs and/or EHR Modules to the 
differences between the certification criteria adopted by the Secretary 
associated with one stage of meaningful use and a subsequent stage of 
meaningful use. As an example, we stated that if the Secretary were to 
adopt 5 new certification criteria to support meaningful use Stage 2 
and those were the only additional capabilities that needed to be 
certified in order for a Complete EHR's certification to be valid again 
(i.e., all other certification criteria remained the same) for the 
purposes of meaningful use Stage 2, then the Complete EHR would only 
have to be tested and certified to those 5 criteria rather than the 
entire set of certification criteria again.
    We noted that differential certification could be a valuable and 
pragmatic approach for the future and that it may further reduce costs 
for certification and expedite the certification process. Accordingly, 
we requested public comments on whether we should require ONC-ACBs to 
offer differential certification, what factors we should consider in 
determining when differential certification would be appropriate and 
when it would not, and when differential certification should begin. To 
further clarify these requests and inform commenters, we noted the 
factors we thought were appropriate for consideration in determining 
when to allow for differential certification. These factors included 
whether the standard(s) associated with a certification criterion or 
criteria changed and whether additional certification criteria changed 
in such a way that they affected other previously certified 
capabilities of a Complete EHR or EHR Module. We specifically asked 
whether differential certification should be permitted to begin with 
Complete EHRs and EHR Modules certified under the temporary 
certification program (i.e., the differences between 2011 and 2013) or 
after all Complete EHRs and EHR Modules had been certified once under 
the permanent certification program (i.e., the differences between 2013 
and 2015). Regarding these options, we asked commenters to consider the 
differences in rigor that we expect Complete EHRs and EHR Modules will 
go through to get certified under the permanent certification program.
    Comments. Commenters overwhelmingly supported some form of 
differential certification based on, as we noted, the potential for 
efficiencies and lower certification costs. These commenters expressed 
general agreement with the factors we specified for determining when 
differential certification would be appropriate. That is, they stated 
that testing and certifying a Complete EHR or EHR Module to only new or 
revised certification criteria would be appropriate as long as other 
required capabilities (as specified in other adopted certification 
criteria) of a Complete EHR or other EHR Modules were not also affected 
by the new or revised certification criteria. Conversely, a few 
commenters did not believe that differential certification would be 
appropriate based on various concerns. One commenter suggested that 
testing to only new or revised certification criteria could be time 
consuming and cost prohibitive. Another commenter contended that 
differential certification will create ``tiers'' in the market of fully 
certified versus differentially certified Complete EHRs and EHR 
Modules, which could lead to confusion among purchasers. A couple of 
commenters expressed concern about ONC-ACBs guaranteeing the compliance 
of all capabilities required by adopted certification criteria of a 
Complete EHR without testing all of the components. A couple of 
commenters also noted that if differential certification is allowed, 
ONC-ACBs should not be required to offer it as an option for 
certification. Rather, it should be up to each ONC-ACB to decide 
whether to conduct differential certification.
    Commenters who were in favor of differential certification 
indicated strong support for beginning differential certification with 
the differences between the 2011 and 2013 certification criteria 
adopted by the Secretary. These commenters reasoned that the potential 
for lower certification costs and reduced certification times should be 
made available to the market as soon as possible, particularly if the 
separate testing and certification processes of the permanent 
certification program could increase the time for certified Complete 
EHRs and EHR Modules to reach the market. Alternatively, a few 
commenters stated that it would be more appropriate for Complete EHRs 
and EHR Modules to be tested and certified at least once under the 
proposed more rigorous permanent certification program before they 
would be considered eligible for differential certification.
    Response. We understand based on our research that the term ``gap 
certification'' is commonly used by the HIT industry to refer to the 
concept we have described as ``differential certification.'' As a 
result, for consistency and ease of reference, we will use the term 
``gap certification'' instead of ``differential certification'' for 
purposes of the permanent certification program. The description of 
``differential certification'' that we gave in the Proposed Rule 
focused on the differences between adopted certification criteria as 
related to the stages of meaningful use. As noted earlier in this final 
rule, however, the Medicare and Medicaid EHR Incentive Programs final 
rule indicated that the meaningful use Stage 1 requirements may be 
updated in future rulemaking, such as when the requirements for Stage 2 
are established. As a result, the concept of gap certification must 
allow for the possibility that the Secretary may adopt certification 
criteria through future rulemaking that would encompass and be 
associated with both the revised Stage 1 requirements and newly 
established Stage 2 requirements. This possibility is consistent with 
our position that, regardless of the year and meaningful use stage at 
which an eligible professional or eligible hospital enters the Medicare 
or Medicaid EHR Incentive Programs, they must use Certified EHR 
Technology that has been certified to all of the applicable 
certification criteria adopted by the Secretary at subpart C of part 
170. Thus,

[[Page 1308]]

gap certification must focus on the differences between certification 
criteria that are adopted through rulemaking at different points in 
time rather than the differences between the stages of meaningful use.
    We define and will use the term gap certification to mean the 
certification of a previously certified Complete EHR or EHR Module to: 
(1) All applicable new and/or revised certification criteria adopted by 
the Secretary at subpart C of this part based on the test results of a 
NVLAP-accredited testing laboratory; and (2) all other applicable 
certification criteria adopted by the Secretary at subpart C of this 
part based on the test results used previously to certify the Complete 
EHR or EHR Module. We believe this definition of gap certification is 
conceptually analogous to the description of differential certification 
in the Proposed Rule as well as common industry usage of the term.
    While a commenter asserted that testing to only new or revised 
certification criteria could be more time consuming and cost 
prohibitive, commenters overwhelmingly agreed with our premise that gap 
certification would likely be a less costly and time-consuming 
certification option for Complete EHR and EHR Module developers. 
Further, we believe that the potential lower costs and expedited 
certification timeframes that gap certification will presumably offer 
outweigh the concerns some commenters raised about the reliability of 
testing under the temporary certification program. As previously stated 
in this final rule, the testing and certification performed under the 
temporary certification program is conducted by testing and 
certification bodies that are determined to be qualified and have been 
authorized by the National Coordinator. Complete EHRs and EHR Modules 
are tested by ONC-ATCBs using test tools and test procedures approved 
by the National Coordinator and should be expected to perform 
consistent with their certifications. Therefore, ONC-ACBs should be 
confident in relying upon the test results provided by ONC-ATCBs when 
performing gap certification under the permanent certification program. 
Accordingly, gap certification will be available as an option for ONC-
ACBs to offer as soon as ONC-ACBs are authorized to begin performing 
certifications under the permanent certification program.
    A few commenters suggested that gap certification would lead to 
``tiers'' in the market of ``fully tested and certified'' Complete EHRs 
and EHR Modules and ``partially tested and certified'' Complete EHRs 
and EHR Modules, while a couple of other commenters expressed concern 
about ONC-ACBs guaranteeing the compliance of all capabilities of a 
Complete EHR without testing all of the components. We believe, as 
suggested by commenters, that the decision on whether to conduct gap 
certification is best left to each ONC-ACB. However, as discussed 
above, we believe that the testing performed by ONC-ATCBs or by any 
NVLAP-accredited testing laboratory will be valid and reliable. 
Therefore, when gap certifying a Complete EHR or EHR Module, an ONC-ACB 
will be expected to issue a certification for the entire Complete EHR 
or EHR Module that it gap certifies. For these reasons, the HIT market 
should consider a Complete EHR or EHR Module that has been gap 
certified to be equal to a Complete EHR or EHR Module that has been 
fully tested and certified to all applicable certification criteria 
adopted by the Secretary. In addition, as discussed earlier in this 
preamble, ONC-ACBs will be expected to conduct annual surveillance of 
the Complete EHRs and/or EHR Modules that they certify under the 
permanent certification program. Surveillance should provide additional 
assurances to the HIT market that Complete EHRs and EHR Modules will 
continue to perform in an operational setting or ``live'' environment 
as they did when they were certified.
    Consistent with this discussion, we are adding the definition of 
gap certification to Sec.  170.502 and adding new provisions to Sec.  
170.545 (paragraph (c)) and Sec.  170.550 (paragraph (c)) to permit 
ONC-ACBs to provide the option of and to perform gap certification 
under the permanent certification program. In addition to these 
revisions, we are revising Sec.  170.523(h) to permit ONC-ACBs to 
accept the results of testing performed on Complete EHRs and EHR 
Modules by ONC-ATCBs under the temporary certification program for the 
purpose of gap certification. These testing results may be necessary 
for conducting gap certification under the permanent certification 
program when previously certified Complete EHRs and EHR Modules were 
last tested under the temporary certification program.

Q. Barriers to Entry for Potential ONC-ACBs and an ONC-Managed 
Certification Process

    We noted in the Proposed Rule that the overall success of the 
Medicare and Medicaid EHR Incentive Programs could be jeopardized if 
the certification program for EHR technology fails to operate properly. 
We requested public comment on specific issues related to the proposed 
permanent certification program that could adversely affect the 
operation of that program. First, we asked whether the proposed 
provisions of the permanent certification program created high barriers 
to market entry for potential ONC-ACBs and, if so, how we could revise 
the proposed requirements to lower those barriers and encourage 
participation. Second, we expressed concern about the potential risks 
to the permanent certification program if no ONC-ACBs were authorized 
or only one ONC-ACB was authorized and engaged in monopolistic 
behavior. We requested public comment on potential approaches that 
could be pursued to stimulate market involvement or remedy these 
situations if they were to develop, including the possibility of the 
National Coordinator establishing a temporary ONC-managed certification 
process that would include some type of certification review board. We 
noted that this option was not preferred and would come with 
significant limitations. In particular, section 3001(c)(5) of the PHSA 
does not expressly authorize the National Coordinator or the Secretary 
to assess and collect fees related to the certification of HIT and 
subsequently retain and use those fees to administer an ONC-managed 
certification process if it were established.
    Comments. Commenters stated that the proposed provisions of the 
permanent certification program did not present high barriers to entry 
for potential ONC-ACBs. Commenters also generally agreed that we should 
eliminate any identified barriers to entry with one commenter 
specifically suggesting that the National Coordinator could waive 
certain conditions that are creating barriers to entry as long as it 
would not adversely impact patient safety or quality of care. Another 
commenter noted that the proposed permanent certification program 
permits multiple entry points for organizations to pursue ONC-ACB 
status, allowing the market to decide how many ONC-ACBs are acceptable.
    Most commenters expressed agreement with our proposal for a 
temporary ONC-managed certification process to stimulate market 
involvement or remedy the situations described above and in the 
Proposed Rule. Some commenters suggested that if there were fewer than 
two ONC-ACBs at the start of the permanent certification program we 
should continue the temporary certification program or allow ONC-ATCBs 
in good standing under the temporary certification program to

[[Page 1309]]

become ONC-ACBs under the permanent certification program without 
having to meet any of the application requirements of the permanent 
certification program. Another commenter suggested that if these 
options were not immediately viable then we should allow for self-
attestation by Complete EHR and EHR Module developers to the 
certification criteria until there are a sufficient number of ONC-ACBs. 
Conversely, some commenters contended that if there was only one ONC-
ACB it would not necessarily be the result of the permanent 
certification program requirements. Although these commenters stated 
that the authorization of more than one ONC-ACB would be preferable to 
handle requests for certification, they asserted that one ONC-ACB could 
be a good starting point for the permanent certification program, at 
least until other ONC-ACBs became operational. A commenter reasoned 
that the accreditation guidelines that ONC-ACBs must adhere to should 
be sufficient to preclude a single ONC-ACB from acting in a 
monopolistic or other improper manner.
    Response. We agree with many of the sentiments expressed by the 
commenters. We agree that there are multiple entry points for qualified 
organizations who seek to become ONC-ACBs, such as applying to become 
an ONC-ACB for only Complete EHRs, only EHR Modules, or only limited 
types of EHR Modules. We also agree that the market will likely 
determine the appropriate number of ONC-ACBs and that only one ONC-ACB 
may be sufficient for starting (and potentially operating long term) 
the permanent certification program. For comparison, consistent with 
our estimate, there are currently 5 ONC-ATCBs under the temporary 
certification program. We acknowledge, however, that there remains the 
remote possibility that there may be no ONC-ACBs under the permanent 
certification program, that one ONC-ACB will not be sufficient to meet 
demand, or that only one ONC-ACB will be authorized and could engage in 
conduct that is detrimental to the permanent certification program.
    To begin the permanent certification program, we believe that we 
have established an approach that addresses the concerns expressed by 
some commenters and is consistent with the solutions they offered. 
Section 170.490 provides that the temporary certification program will 
sunset on December 31, 2011, or if the permanent certification program 
is not fully constituted at that time, then upon a subsequent date that 
is determined to be appropriate by the National Coordinator. We stated 
in the Temporary Certification Program final rule that in determining 
whether the permanent certification program is fully constituted, the 
National Coordinator would consider whether there are a sufficient 
number of ONC-ACBs and accredited testing laboratories to address the 
current market demand. We believe this approach will ensure that the 
permanent certification program functions properly at the outset. If we 
determine at a later time under the permanent certification program 
that an insufficient number of ONC-ACBs exists, we will consider what 
steps may be taken to remedy the situation. This may include 
implementing a temporary ONC-managed certification process and/or 
evaluating other means for stimulating the market, such as revising or 
waiving certain ONC-ACB requirements or taking other actions as 
suggested by the commenters.

R. General Comments

    We received comments that were not attributable to a specific 
provision of the permanent certification program, but were still 
reasonably within the scope of the program. These comments addressed 
the timing of the permanent certification program; ``grandfathering'' 
of previously certified technology; the potential for a backlog of 
requests for certification; the costs of certification; and the safety 
of Complete EHRs, EHR Modules and other types of HIT.
    Comments. Although we did not propose or discuss the concept of 
``grandfathering'' in the Proposed Rule, several commenters made 
recommendations on the subject. To summarize the discussion of comments 
in the Temporary Certification Program final rule, in general, the 
concept of grandfathering would allow technology that had been 
certified prior to the inception of the temporary and/or permanent 
certification programs to be deemed Certified EHR Technology.
    Response. In the Temporary Certification Program final rule, we 
responded to comments on the concept of grandfathering and concluded 
that any form of grandfathering would be inappropriate for purposes of 
our certification programs and inconsistent with the statutory 
requirements for Certified EHR Technology set forth in the PHSA. 75 FR 
36186-36187. Our position on grandfathering as stated in the Temporary 
Certification Program final rule remains valid.
    Comments. Commenters requested that we take action to prevent 
testing and certification monopolies and backlogs of requests for 
testing and certification. Commenters also requested that we mandate 
pricing for certification or at least establish a reasonable fee 
requirement.
    Response. We believe that through the policies we have established 
in this final rule, the permanent certification program is inclusive of 
as many potential applicants for ONC-ACB status as possible, and that 
we have created an environment that is likely to result in multiple 
ONC-ACBs. Further, we believe that multiple ONC-ACBs and market 
dynamics, particularly competition, will address the commenters' 
concerns about potential monopolies, appropriate costs for 
certification, and the timely and efficient processing of requests for 
the certification of Complete EHRs and EHR Modules. Accreditation will 
require that potential ONC-ACBs comply with Guide 65, which requires 
certification bodies to make their services accessible to all 
applicants whose activities fall within its declared field of operation 
(i.e., the permanent certification program), including not having any 
undue financial or other conditions. As noted throughout this rule, an 
ONC-ACB must maintain its accreditation to remain in good standing 
under the permanent certification program.
    Comments. A commenter requested that the National Coordinator 
establish a single application process for the testing and 
certification of developers' HIT. By doing so, the commenter contended 
that this would alert accredited testing laboratories and ONC-ACBs of a 
developer's readiness and intent to apply for testing and/or 
certification.
    Response. We do not believe it is necessary or appropriate to 
create such an ``application process.'' Each accredited testing 
laboratory and ONC-ACB is capable of establishing their own customer 
base based on a multitude of factors including pricing, efficiency, 
services offered, and prior relationships. Further, we assume that a 
HIT developer's readiness and ``intent'' to apply may fluctuate based 
on multiple factors, including whether their Complete EHR and/or EHR 
Module successfully passed testing or whether they determine testing 
and/or certification of their HIT should be delayed. Accordingly, we 
believe it is appropriate for each accredited testing laboratory and 
ONC-ACB to establish its own process for soliciting and accepting 
requests for testing and certification, as applicable.
    Comments. A few commenters expressed concern over the potential 
safety risks that could be associated with poorly planned, implemented, 
and

[[Page 1310]]

used EHR technology and suggested that patient safety should be 
considered in the development and implementation of the permanent 
certification program.
    Response. We understand and are acutely aware of the concerns 
expressed by the commenters regarding patient health and safety. We 
believe that the permanent certification program has been sufficiently 
constituted to ensure that ONC-ACBs will competently certify Complete 
EHRs, EHR Modules and potentially other types of HIT. We have 
established a process in the permanent certification program that the 
National Coordinator could use to immediately suspend an ONC-ACB's 
authority to issue certifications if there is reliable evidence 
indicating that allowing the ONC-ACB to continue issuing certifications 
would pose an adverse risk to patient health and safety. The permanent 
certification program also includes a post-market surveillance program 
that is designed to ensure that certified Complete EHRs and EHR Modules 
perform in the market as certified and may also shed light on any 
safety concerns reported by eligible professionals and eligible 
hospitals.

S. Comments Beyond the Scope of This Final Rule

    In response to the Proposed Rule, some commenters chose to raise 
issues that are beyond the scope of our proposals. We do not summarize 
or respond to those comments in this final rule. However, we will 
review the comments and consider whether other actions may be 
necessary, such as addressing the comments in later rulemakings or 
through guidance clarifying program operating procedures, based on the 
information or suggestions in the comments.

IV. Provisions of the Final Regulation

    For the most part, this final rule incorporates the provisions of 
the Proposed Rule. Those provisions of this final rule that differ from 
the Proposed Rule are as follows:
    <bullet> In Sec.  170.501, we added language, based on our proposal 
and public comments, that expands the scope of the permanent 
certification program to ``other types of HIT.'' We also added ``the 
requirements that ONC-ACBs must follow to maintain their status'' to 
properly identify that this subpart contains requirements that ONC-ACBs 
must follow to maintain their status under the permanent certification 
program.
    <bullet> In Sec.  170.502, we revised the definition of applicant 
by removing the condition that an applicant must ``request'' an 
application. We revised the definition of ONC-ACB by removing ``at a 
minimum'' from the definition to allow an organization or consortium of 
organizations to become an ONC-ACB that is authorized to certify only 
types of HIT besides Complete EHRs and/or EHR Modules. We also revised 
this definition by replacing ``using the applicable certification 
criteria adopted by the Secretary'' with ``under the permanent 
certification program.'' In addition to revising the definitions of 
applicant and ONC-ACB, we added the definitions of ``deployment site,'' 
``development site,'' ``gap certification,'' ``providing or provide an 
updated certification,'' and ``remote certification'' to this section.
    <bullet> In Sec.  170.503, we revised paragraph (b) to provide for 
a 30-day time period in which all interested accredited organizations 
may submit requests for ONC-AA status. We revised (b)(2) to specify 
that a request for ONC-AA status must include a detailed description of 
how the accreditation organization will ensure that the surveillance 
approaches used by ONC-ACBs include the use of consistent, objective, 
valid, and reliable methods. We revised paragraph (c) to permit the 
National Coordinator up to 60 days to review all timely submissions and 
determine which accreditation organization is best qualified to serve 
as the ONC-AA. We revised paragraph (c) to provide for the selection of 
an ONC-AA on a preliminary basis and subject to the resolution of the 
reconsideration process in Sec.  170.504. We included in paragraph (c) 
the option, originally specified in proposed paragraph (d), for an 
accreditation organization to request reconsideration of the National 
Coordinator's decision to deny an accreditation organization ONC-AA 
status. We established a new provision, designated as paragraph (d), 
that specifies the final approval process for ONC-AA status. We revised 
paragraph (e)(2) to require an ONC-AA, in accrediting certification 
bodies, to ensure that surveillance approaches include the use of 
consistent, objective, valid and reliable methods. We revised paragraph 
(e)(4) to state that the ONC-AA will be required to review ONC-ACB 
surveillance results to determine if the results indicate any 
substantive non-conformance by ONC-ACBs ``with the conditions of their 
respective accreditations.'' We revised paragraph (f) to specify that 
an accreditation organization has not been granted ONC-AA status unless 
and until it is notified by the National Coordinator that it has been 
approved as the ONC-AA on a final basis pursuant to paragraph (d) of 
this section. We also revised paragraph (f) to specify that the 
National Coordinator will accept requests for ONC-AA status, in 
accordance with paragraph (b), at least 180 days before the then 
current ONC-AA's status is set to expire.
    <bullet> In Sec.  170.504, consistent with our revisions to Sec.  
170.503, we revised paragraph (a) to state that an accreditation 
organization that submits a timely request for ONC-AA status in 
accordance with Sec.  170.503 and is denied may ask the National 
Coordinator to reconsider the decision to deny its request for ONC-AA 
status. We revised paragraph (b) to state that the accreditation 
organization's request for reconsideration must demonstrate that clear, 
factual errors were made in the review of its request for ONC-AA status 
and that the accreditation organization would have been selected as the 
ONC-AA pursuant to Sec.  170.503(c) if those errors had been corrected. 
We revised paragraph (c) to permit the National Coordinator up to 30 
days to review all timely received reconsideration requests and 
determine whether an accreditation organization has met the standard 
specified in paragraph (b) of this section. We revised paragraph (d) to 
state that if the National Coordinator determines that an accreditation 
organization has met the standard specified in paragraph (b) of this 
section, then that organization will be approved as the ONC-AA on a 
final basis and all other accreditation organizations will be notified 
that their requests for reconsideration have been denied.
    <bullet> In Sec.  170.505, we revised paragraph (b) by adding ``or 
ONC-ACB'' to clarify that either an applicant for ONC-ACB status or an 
ONC-ACB may, when necessary, utilize the specified correspondence 
methods. We also revised this section to apply its correspondence 
requirements to accreditation organizations that submit requests for 
ONC-AA status and the ONC-AA.
    <bullet> In Sec.  170.520, we revised paragraph (c) such that the 
documentation provided by the applicant must confirm that the applicant 
has been accredited by ``the ONC-AA,'' instead of ``an ONC-AA'' as 
proposed.
    <bullet> In Sec.  170.523, we revised paragraph (e) by clarifying 
that site visits will be conducted during normal business hours. We 
revised paragraph (f) by replacing ``vendor'' with ``Complete EHR or 
EHR Module developer.'' We also revised paragraph (f) by specifying 
that an ONC-ACB will be required to additionally report the clinical 
quality measures to which a Complete EHR or

[[Page 1311]]

EHR Module has been certified and, where applicable, any additional 
software a Complete EHR or EHR Module relied upon to demonstrate its 
compliance with a certification criterion or criteria adopted by the 
Secretary. We revised paragraph (h) to require ONC-ACBs to only certify 
HIT, including Complete EHRs and/or EHR Module(s), that has been tested 
by a NVLAP-accredited testing laboratory using test tools and test 
procedures that have been approved by the National Coordinator. We also 
revised paragraph (h) to allow ONC-ACBs, under certain circumstances, 
to rely on testing that has been performed by ONC-ATCBs, which must 
also have been done using test tools and test procedures that have been 
approved by the National Coordinator. We revised paragraph (j) to 
clarify that an ONC-ACB will only be responsible for issuing refunds in 
situations where the ONC-ACB's conduct caused certification to be 
suspended and a request for certification is withdrawn, and in 
instances where the ONC-ACB's conduct caused the certification not to 
be completed or necessitated the recertification of Complete EHRs and/
or EHR Module(s) that had been previously certified. Lastly, we added a 
new Principle of Proper Conduct for ONC-ACBs and designated it as 
paragraph (k). The new Principle of Proper Conduct will require ONC-
ACBs to ensure that all Complete EHRs and EHR Modules are properly 
identified and marketed.
    <bullet> In Sec.  170.525, we revised paragraph (b) by removing 
``during the existence of the permanent certification program.''
    <bullet> In Sec.  170.530, in response to public comment, we 
revised paragraph (b)(1) by removing the terms ``inadvertent'' and 
``minor.'' We revised paragraph (c)(1), also in response to public 
comment, to allow an applicant for ONC-ACB status to request an 
extension of the 15-day period provided to submit a revised application 
in response to a deficiency notice. We revised paragraph (c)(2) to 
state that the National Coordinator can grant an applicant's request 
for an extension of the 15-day period based on a finding of good cause. 
We revised paragraph (c)(3) to permit the National Coordinator to 
request clarification of statements and the correction of errors or 
omissions in a revised application during the 15-day period that the 
National Coordinator has to review a revised application. Finally, we 
revised paragraph (c)(4) to state that a denial notice issued to an 
applicant will indicate that the applicant cannot reapply for ONC-ACB 
status for a period of six months from the date of the denial notice.
    <bullet> In Sec.  170.540, we revised paragraph (b) to state, in 
relevant part, ``Each ONC-ACB must prominently and unambiguously 
identify the scope of its authorization on its Web site, and in all 
marketing and communications statements (written and oral) pertaining 
to its activities under the permanent certification program.'' We 
clarified in paragraph (c) that an ONC-ACB must include any updates to 
the information required to be provided under Sec.  170.520 when 
requesting to have its status renewed. We also revised paragraph (c) to 
state that an ONC-ACB will need to have its status renewed every three 
years instead of every two years. We similarly revised paragraph (d) to 
state that an ONC-ACB's status will expire three years from the date it 
was granted by the National Coordinator unless it is renewed.
    <bullet> In Sec.  170.545, we revised paragraph (a) to state that 
``When certifying Complete EHRs, an ONC-ACB must certify Complete EHRs 
in accordance with all applicable certification criteria adopted by the 
Secretary at subpart C of this part.'' We redesignated proposed 
paragraph (b) as paragraph (e). We added three new provisions. We added 
a new provision, designated as paragraph (b), which states that an ONC-
ACB must provide the option for a Complete EHR to be certified solely 
to the applicable certification criteria adopted by the Secretary at 
subpart C of this part. We added a new provision, designated as 
paragraph (c), to permit ONC-ACBs to provide the option for and perform 
gap certification. Finally, we added a new provision, designated as 
paragraph (d), which requires an ONC-ACB to accept requests for a newer 
version of a previously certified Complete EHR to inherit the certified 
status of the previously certified Complete EHR without requiring the 
newer version to be recertified.
    <bullet> In Sec.  170.550, we removed proposed paragraphs (b) and 
(d) because they were redundant of other regulatory requirements within 
this subpart. We redesignated proposed paragraph (c) as paragraph (e) 
and revised it to state that EHR Modules shall be certified to all 
privacy and security certification criteria adopted by the Secretary 
unless the EHR Module(s) is presented for certification in one of the 
following manners: (1) The EHR Modules are presented for certification 
as a pre-coordinated, integrated bundle of EHR Modules, which would 
otherwise meet the definition of and constitute a Complete EHR, and one 
or more of the constituent EHR Modules is demonstrably responsible for 
providing all of the privacy and security capabilities for the entire 
bundle of EHR Modules; or (2) An EHR Module is presented for 
certification, and the presenter can demonstrate and provide 
documentation to the ONC-ACB that a privacy and security certification 
criterion is inapplicable or that it would be technically infeasible 
for the EHR Module to be certified in accordance with such 
certification criterion. We added four new provisions. We added a new 
provision, designated as paragraph (b), which states that an ONC-ACB 
must provide the option for an EHR Module(s) to be certified solely to 
the applicable certification criteria adopted by the Secretary at 
subpart C of this part. We added a new provision, designated as 
paragraph (c), to permit ONC-ACBs to provide the option for and perform 
gap certification. We added a new provision, designated as paragraph 
(d), which permits an ONC-ACB to provide an updated certification to a 
previously certified EHR Module(s). Finally, we added a new provision, 
designated as paragraph (f), which requires an ONC-ACB to accept 
requests for a newer version of a previously certified EHR Module(s) to 
inherit the certified status of the previously certified EHR Module(s) 
without requiring the newer version to be recertified.
    <bullet> In Sec.  170.555, we removed inadvertent references to 
testing under the permanent certification program.
    <bullet> In Sec.  170.557, we revised the section to require that 
an ONC-ACB provide remote certification for both development and 
deployment sites.
    <bullet> In Sec.  170.565, we revised paragraph (c)(1) to state 
that ``[t]he National Coordinator may propose to revoke an ONC-ACB's 
status if the National Coordinator has reliable evidence that the ONC-
ACB committed a Type-1 violation.'' The term ``reliable'' was 
inadvertently left out of the Proposed Rule. We also established a new 
provision. We designated this provision as paragraph (d) and 
redesignated proposed paragraphs (d) through (g) as paragraphs (e) 
through (h), respectively. Paragraph (d) provides the National 
Coordinator with the discretion to suspend an ONC-ACB's operations if 
there is reliable evidence indicating that the ONC-ACB has committed a 
Type-1 or Type-2 violation and that the continued certification of 
Complete EHRs, EHR Modules and/or other types of HIT by the ONC-ACB 
could have an adverse impact on patient health or safety. An ONC-ACB 
will have 3 days to respond to a notice of proposed suspension by 
explaining in writing why its operations should not be suspended. The 
National Coordinator

[[Page 1312]]

will be permitted up to 5 days to review the response and issue a 
determination to the ONC-ACB. The National Coordinator will make a 
determination to either rescind the proposed suspension, suspend the 
ONC-ACB until it has adequately corrected a Type-2 violation, or 
propose revocation in accordance with Sec.  170.565(c) and suspend the 
ONC-ACB's operations for the duration of the revocation process. The 
National Coordinator may also make any one of the above determinations 
if an ONC-ACB fails to submit a timely response to a notice of proposed 
suspension. A suspension will become effective upon an ONC-ACB's 
receipt of a notice of suspension.
    <bullet> We added Sec.  170.599 to incorporate by reference ISO 
17011 and Guide 65.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), agencies are 
required to provide 60-day notice in the Federal Register and solicit 
public comment on a proposed collection of information before it is 
submitted to the Office of Management and Budget (OMB) for review and 
approval. In order to fairly evaluate whether an information collection 
should be approved by OMB, section 3506(c)(2)(A) of the PRA requires 
that we solicit comment on the following issues:
    1. Whether the information collection is necessary and useful to 
carry out the proper functions of the agency;
    2. The accuracy of the agency's estimate of the information 
collection burden;
    3. The quality, utility, and clarity of the information to be 
collected; and
    4. Recommendations to minimize the information collection burden on 
the affected public, including automated collection techniques.
    In the Proposed Rule, we solicited public comment on each of these 
issues for the information collections set forth in 45 CFR Sec. Sec.  
170.503(b), 170.520, and 170.523(f) and (g). The final rule also 
specifies another information collection requirement pertaining to the 
annual submission by an ONC-ACB of a surveillance plan and surveillance 
results to the National Coordinator as required by Sec.  170.523(i). 
The information collection requirement of Sec.  170.523(i) was not 
specifically identified in the Proposed Rule, but was available for 
comment during the 60-day public comment period for the Proposed Rule 
and included in our request to OMB. Please refer to section E below for 
this information collection.

A. Collection of Information: Required Documentation for Requesting 
ONC-Approved Accreditor Status Under the Permanent Certification 
Program

    Section 170.503(b) requires an accreditation organization to submit 
specific information to the National Coordinator to be considered for 
ONC-AA status under the permanent certification program. We estimated 
in the Proposed Rule that there will only be two accreditation 
organizations that will prepare and submit the information sought by 
the National Coordinator to be considered for ONC-AA status. We also 
provided estimates for the amount of time we believe will be necessary 
to collect and provide the information requested by the National 
Coordinator in Sec.  170.503(b). Specifically, we estimated that it 
will take approximately:
    <bullet> 20 minutes for an accreditation organization to provide a 
detailed description of the accreditation organization's conformance to 
ISO 17011 and experience evaluating the conformance of certification 
bodies to Guide 65;
    <bullet> 20 minutes for an accreditation organization to provide a 
detailed description of the accreditation organization's accreditation 
requirements and how the requirements complement the Principles of 
Proper Conduct for ONC-ACBs;
    <bullet> 5 minutes for an accreditation organization to provide a 
copy of the procedures that would be used to monitor ONC-ACBs;
    <bullet> 10 minutes for an accreditation organization to provide 
detailed information, including education and experience, about the key 
personnel who review certification bodies for accreditation; and
    <bullet> 5 minutes for an accreditation organization to provide a 
copy of the procedures for responding to, and investigating, complaints 
against ONC-ACBs.
    We did not receive any comments on our estimates for the burden 
associated with Sec.  170.503(b). We added the requirement that 
accreditation organizations specify how their accreditation 
requirements will ensure the surveillance approaches used by ONC-ACBs 
include the use of consistent, objective, valid, and reliable methods. 
We do not believe that this additional requirement will appreciably 
increase the burden for accreditation organizations requesting ONC-AA 
status and that any potential increase in the burden can be accounted 
for in the 20 minutes allotted for providing a detailed description of 
the accreditation organization's accreditation requirements and how the 
requirements complement the Principles of Proper Conduct for ONC-ACBs. 
Therefore, we have maintained the same burden estimates we provided in 
the Proposed Rule.

----------------------------------------------------------------------------------------------------------------
                                                                 Number of      Average  burden
            Type of  respondent                Number of       responses per       hours  per      Total burden
                                              respondents        respondent         response          hours
----------------------------------------------------------------------------------------------------------------
Accreditation Organization................               2                  1                1                2
----------------------------------------------------------------------------------------------------------------

B. Collection of Information: Application for ONC-ACB Status Under the 
Permanent Certification Program

    Section 170.520 requires an organization to submit specific 
information to the National Coordinator to be considered for ONC-ACB 
status under the permanent certification program. We estimated in the 
Proposed Rule that there would be no more than 6 applicants for ONC-ACB 
status under the permanent certification program. We also provided 
estimates for the amount of time we believe will be necessary to 
complete an application for ONC-ACB status, i.e., meet the requirements 
of Sec.  170.520. Specifically, we estimated that it will take 
approximately:
    <bullet> 10 minutes to provide the general identifying information 
requested in the application;
    <bullet> 30 minutes to assemble the information necessary to 
provide documentation of accreditation by an ONC-AA; and
    <bullet> 20 minutes to review and agree to the ``Principles of 
Proper Conduct for ONC-ACBs.''
    Our burden estimates were based on the assumption that potential 
applicants will be familiar with many of the application requirements 
and will, for example, already have a majority--if not all--of the 
documentation requested

[[Page 1313]]

already developed and available before applying for ONC-ACB status.
    Comments. We received one comment expressing agreement that most 
potential applicants would likely have a majority of the necessary 
documentation available when applying for ONC-ACB status. The commenter 
contended, however, that we should add a minimum of an additional 200 
hours of staff time in consideration of the effort that will be 
required by an organization to become accredited, which the commenter 
noted is a prerequisite for applying for ONC-ACB status.
    Response. We believe that the commenter's concerns related to the 
effort to become accredited are best addressed in our discussion of 
accreditation costs for potential ONC-ACB applicants under the 
regulatory impact analysis section of this final rule. The burden 
described under this section is for PRA purposes and is confined to the 
actual collection and submission of information required to apply for 
ONC-ACB status as specified in Sec.  170.520. We note, however, that in 
the Proposed Rule we did not specifically attribute an amount of time 
(i.e., burden) to identifying the type of authorization sought by a 
potential applicant. Although identifying the type of authorization 
sought is a requirement of Sec.  170.520, we believe any time utilized 
to provide this information can be accounted for within the 10 minutes 
we have allotted for providing the requested general identifying 
information. Accordingly, our estimate of the burden for an applicant 
to collect and submit the information necessary to apply for ONC-ACB 
status remains the same as specified in the Proposed Rule.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
             Type of respondent                  Number of      responses per     Burden hours     Total burden
                                                respondents       respondent      per response        hours
----------------------------------------------------------------------------------------------------------------
Applicant...................................               6                1                1                6
----------------------------------------------------------------------------------------------------------------

C. Collection of Information: ONC-ACB Collection and Reporting of 
Information Related to Complete EHR and/or EHR Module Certifications

    Section 170.523(f) requires an ONC-ACB to provide ONC, no less 
frequently than weekly, a current list of Complete EHRs and/or EHR 
Modules that have been certified as well as certain minimum information 
about each certified Complete EHR and/or EHR Module.
    We did not receive any comments on this collection of information. 
We have, however, as we did for the related temporary certification 
program provision, specified in this final rule two additional 
reporting elements that must be submitted by ONC-ACBs on a weekly basis 
(i.e., clinical quality measures to which a Complete EHR or EHR Module 
has been certified and, where applicable, any additional software a 
Complete EHR or EHR Module relied upon to demonstrate its compliance 
with a certification criterion or criteria adopted by the Secretary). 
ONC-ACBs will be capturing these additional reporting elements in 
conjunction with the other information we request that they report on a 
weekly basis. Consequently, we do not believe that the reporting of 
these two additional elements will increase the reporting burden for 
ONC-ACBs.
    For the purposes of estimating the potential burden, we have 
maintained our prior assumptions. We assume that all of the estimated 
applicants will apply and become ONC-ACBs (i.e., 6 applicants). We also 
assume that ONC-ACBs will report weekly (i.e., respondents will respond 
52 times per year). Finally, we assume that the information collections 
will be accomplished through electronic data collection and storage, 
which will be part of the normal course of business for ONC-ACBs. 
Therefore, with respect to this proposed collection of information, the 
estimated burden is limited to the actual electronic reporting of the 
information to ONC.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
             Type of respondent                  Number of      responses per      hours  per      Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ONC-ACB Certification Results...............               6               52                1              312
----------------------------------------------------------------------------------------------------------------

D. Collection of Information: Records Retention Requirements

    Section 170.523(g) requires ONC-ACBs to retain certification 
records for 5 years. In the Proposed Rule, we stated our belief, based 
on our consultations with NIST, that the 5-year requirement was in line 
with common industry practice and, consequently, would not represent an 
additional cost to ONC-ACBs. We did not receive any comments related to 
our assertion and, therefore, maintain our belief that the 5-year 
record retention requirement will not create a burden or additional 
cost for ONC-ACBs.

E. Collection of Information: Submission of Surveillance Plan and 
Surveillance Results

    Section 170.523(i) requires an ONC-ACB to submit an annual 
surveillance plan to the National Coordinator and annually report to 
the National Coordinator its surveillance results.
    For the purposes of estimating the potential burden, we assume that 
all of the estimated number of applicants for the permanent 
certification program (i.e., six) will become ONC-ACBs. We anticipate 
that the burden for each ONC-ACB will be the same based on the 
following assumptions. We assume that all surveillance plans will be 
fairly comparable. We also assume that all ONC-ACBs will, on average, 
have a similar burden in submitting results. Finally, we assume that an 
ONC-ACB will submit a copy of their annual surveillance plan and 
annually report surveillance results by either electronic transmission 
or paper submission. In either instance, we believe that an ONC-ACB 
will spend a similar amount of time and effort in organizing, 
categorizing and submitting the requested information. Therefore, we 
estimate that an ONC-ACB will annually allocate 1 hour to submit the

[[Page 1314]]

plan (response <greek-i>1) and 1 hour to report the results (response 
<greek-i>2). Our estimates are expressed in the table below.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
             Type of respondent                  Number of      responses per      hours  per      Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ONC-ACB Surveillance Plan and Results.......               6                2                1               12
----------------------------------------------------------------------------------------------------------------

    As required by section 3504(h) of the PRA, we have submitted a copy 
of this document to OMB for its review of these information collection 
requirements.

VI. Regulatory Impact Analysis

A. Introduction

    We have examined the impacts of this final rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993, as further amended), the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), section 202 of the Unfunded Mandates Reform Act of 
1995 (2 U.S.C. 1532), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any one year). Based on 
the analysis of costs and benefits that follows, we have determined 
that this final rule covering the permanent certification program is 
not an economically significant rule because we estimate that the 
overall costs and benefits associated with the permanent certification 
program, including the costs associated with the testing and 
certification of Complete EHRs and EHR Modules, to be less than $100 
million per year. Nevertheless, because of the public interest in this 
final rule, we have prepared an RIA that to the best of our ability 
presents the costs and benefits of the final rule.

B. Why is this rule needed?

    As stated in earlier sections of this final rule, section 
3001(c)(5) of the PHSA provides the National Coordinator with the 
authority to establish a certification program or programs for the 
voluntary certification of HIT. This final rule is needed to outline 
the processes by which the National Coordinator would exercise this 
authority to authorize certain organizations to certify Complete EHRs, 
EHR Modules, and/or other types of HIT. As to Complete EHRs and EHR 
Modules, once certified, they will be able to be used by eligible 
professionals and eligible hospitals as, or be combined to create, 
Certified EHR Technology. Eligible professionals and eligible hospitals 
who seek to qualify for incentive payments under the Medicare and 
Medicaid EHR Incentive Programs are required by statute to use 
Certified EHR Technology.

C. Executive Order 12866--Regulatory Planning and Review Analysis

1. Comment and Response
    Comments. As recited in the Temporary Certification Program final 
rule, we received a few comments that expressed concerns that the costs 
we attributed in the Proposed Rule related to the testing and 
certification of Complete EHRs and EHR Modules were too high, 
unrealistic, and unreliable. One commenter requested that we remove our 
cost estimates because they believed they were based on a monopolistic 
pricing structure. Other commenters indicated that we should regulate 
the pricing related to testing and certification in order to ensure 
that prices were not exorbitant and did not preclude smaller Complete 
EHR and EHR Module developers from being able to attain certification 
for their EHR technology.
    Response. We understand the commenters' concerns; however, we have 
a responsibility to put forth a good faith effort to estimate the 
potential costs associated with this final rule. Part of that effort 
includes using the best available data to inform our assumptions and 
estimates. While we were open to revising our cost estimates in 
response to public comment, in no instance did a commenter provide 
alternative estimates or reference additional information from which we 
could base revisions. Conversely, we believe that commenters who 
expressed concerns about the potential costs, largely did so from the 
perspective of stating a request that we ensure the costs for testing 
and certification were not prohibitively high.
    While we understand these commenters' perspectives, we do not 
believe that it is appropriate to dictate the minimum or maximum amount 
an ONC-ACB should be able to charge for certifying a Complete EHR or 
EHR Module. Based on the number of applicants we have granted ONC-ATCB 
status, we anticipate that we will there will be multiple ONC-ACBs that 
will compete for market share under the permanent certification 
program. As a result of this expected competition, we believe that 
there could also be increased downward pressure on the costs associated 
with testing and certification. If that cost pressure occurs, we 
believe that the upper ranges of the cost estimates we provide in this 
final rule could be overestimates.
    Comments. We received one comment expressing agreement that most 
potential applicants would likely have a majority of the necessary 
documentation available when applying for ONC-ACB status. The commenter 
contended, however, that we should add a minimum of an additional 200 
hours of staff time in consideration of the effort that will be 
required by an organization to become accredited.
    Response. We believe that attributing 200 hours of staff time for 
preparing and participating in the accreditation process is reasonable. 
We also believe that it is appropriate to calculate the cost of the 
staff time at a position equivalent to a Federal GS-15, Step 1 
employee. Accordingly, we have supplemented our original cost estimates 
to account for this staff time and have provided revised total cost 
estimates for accreditation and the ONC-ACB application process under 
the section titled ``Application Process for ONC-ACB Status'' in this 
RIA.
    Comments. Some commenters questioned our estimates related to the 
number of EHR Modules we expected to be tested and certified. One 
commenter suggested that the number of self-developed EHR Modules 
should be much higher than we estimated. Other commenters expressed 
that this rule

[[Page 1315]]

needed to account for other costs associated with testing and 
certification (e.g., reprogramming a Complete EHR or EHR Module) and 
not just the costs associated with the application process and for 
Complete EHRs and EHR Modules to be tested and certified. One commenter 
suggested that if our estimates of the number of EHR Modules and 
Complete EHRs that will be tested and certified and the costs for 
testing and certification are accurate, then the commenter contended 
that there will not be a sufficient market for sustaining ONC-ACBs and, 
therefore, ONC should assume all costs for testing and certification.
    Response. As discussed in the Temporary Certification Program final 
rule (75 FR 36197), the certification programs final rules are part of 
a coordinated rulemaking effort. Each rule accounts for its specific 
effects. In the ``Health Information Technology: Initial Set of 
Standards, Implementation Specifications, and Certification Criteria 
for Electronic Health Record Technology'' interim final rule (75 FR 
2038), we summarized these effects as follows:

    While there is no bright line that divides the effects of this 
interim final rule and the other two noted above, we believe that 
each analysis properly focuses on the direct effects of the 
provisions it creates. This interim final rule estimates the costs 
commercial vendors, open source developers, and relevant Federal 
agencies will incur to prepare Complete EHRs and EHR Modules to be 
tested and certified to adopted standards, implementation 
specifications, and certification criteria. The Medicare and 
Medicaid EHR Incentive Programs proposed rule estimates the impacts 
related to the actions taken by eligible professionals or eligible 
hospitals to become meaningful users, including purchasing or self-
developing Complete EHRs or EHR Modules. The HIT Certification 
Programs proposed rule estimates the testing and certification costs 
for Complete EHRs and EHR Modules.

    As result, we estimate in this final rule, as we had before, the 
effects of the application process for ONC-ACB status and the costs for 
Complete EHRs and EHR Modules to be tested and certified by ONC-ACBs. 
The HIT Standards and Certification Criteria final rule (75 FR 44590) 
provides our final analysis of the estimated costs commercial vendors, 
open source developers, and relevant Federal agencies will incur to 
prepare Complete EHRs and EHR Modules to be tested and certified to 
adopted standards, implementation specifications, and certification 
criteria, while the Medicare and Medicaid EHR Incentive Programs final 
rule (75 FR 44314) provides a final analysis of the impacts related to 
the actions taken by eligible professionals or eligible hospitals to 
become meaningful users, including purchasing or self-developing 
Complete EHRs or EHR Modules.
    As we stated in the Temporary Certification Program final rule, 
with respect to EHR Modules, especially self-developed EHR Modules, we 
agree with those commenters regarding our estimates and have provided 
revised estimates that factor in a potential larger number of self-
developed EHR Modules. While neither commenter who offered this concern 
related to EHR Modules provided any data to substantiate their claims, 
we determined that this revision was necessary because we had 
previously grouped self-developed Complete EHRs and EHR Modules 
together. Upon further review and other comments addressed above 
regarding EHR Modules, we believe that in order to provide a more 
accurate estimate, self-developed Complete EHRs and EHR Modules should 
be separately accounted for. We believe our prior estimates related to 
self-developed Complete EHRs and EHR Modules are more appropriately 
attributable to the number of self-developed Complete EHRs. 
Accordingly, we have developed new estimates (captured in the 
discussion and tables below) for the number of self-developed EHR 
Modules that we believe will be presented for testing and certification 
under the permanent certification program. We believe that our new 
estimates indicate that there will be a sufficient market to sustain an 
appropriate amount of ONC-ACBs necessary for the success of the 
permanent certification program. Further, we do not believe that it is 
appropriate for ONC to enter the market where private entities have 
concluded that there is a sufficient market for the testing and 
certification of HIT to be willing to perform the testing and 
certification of HIT. This conclusion has arguably been validated by 
the fact that 5 private entities have already become ONC-ATCBs under 
the temporary certification program.
2. Executive Order 12866 Final Analysis
    As required by Executive Order 12866, we have examined the economic 
implications of this final rule as it relates to the permanent 
certification program. Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). Executive Order 12866 classifies a regulation as significant 
if it meets any one of a number of specified conditions, including 
having an annual effect on the economy of $100 million, or in a 
material way adversely affecting the economy, a sector of the economy, 
competition, or jobs. While this final rule is therefore not 
``economically significant,'' as defined by Executive Order 12866, OMB 
has determined that this final rule constitutes a ``significant 
regulatory action'' as defined by Executive Order 12866 because it 
raises novel legal and policy issues.
a. Permanent Certification Program Estimated Costs
i. Request for ONC-AA Status
Costs for Accreditation Organizations
    We believe that at most two accreditation organizations will 
prepare and submit the information sought by the National Coordinator. 
Additionally, we estimate that it will take 1 hour to prepare and 
submit a request for ONC-AA status. We believe that an employee 
equivalent to the Federal Salary Classification of GS-15 Step 1 would 
be responsible for preparing and submitting the required information. 
We have utilized the corresponding employee hourly rate for the 
locality pay area of Washington, DC, as published by the OPM, to 
calculate our cost estimates. We have also calculated the costs of an 
employee's benefits while preparing and submitting the required 
information to be considered for ONC-AA status. We have calculated 
these costs by assuming that an accreditation organization expends 
thirty-six percent (36%) of an employee's hourly wage on benefits for 
the employee. We have concluded that a 36% expenditure on benefits is 
an appropriate estimate because it is the routine percentage used by 
HHS for contract cost estimates. Our cost estimates are expressed in 
Table 2 below.

[[Page 1316]]



Table 2--Permanent Certification Program: Cost to Accreditation Organizations To Submit the Information Required
                                               To Become an ONC-AA
----------------------------------------------------------------------------------------------------------------
                                                                     Employee   Cost of employee
           Requirement                 Employee          Burden    hourly wage    benefits per    Total cost per
                                      equivalent         hours         rate           hour           applicant
----------------------------------------------------------------------------------------------------------------
Submission of Request for ONC-AA  GS-15 Step 1......            1       $59.30            $21.35          $80.65
 Status.
----------------------------------------------------------------------------------------------------------------

    Using our estimates above, we believe that the cost to submit the 
information required to become an ONC-AA will be $81 and the total cost 
for the two accreditation organizations that we estimate will submit 
requests for ONC-AA status will be $161. Based on our estimate of two 
accreditation organizations submitting the required documentation to be 
considered for ONC-AA status and on the requirement that an ONC-AA be 
selected every three years, we estimate the annualized cost of 
requesting ONC-AA status to be $54.
Costs to the Federal Government
    We anticipate that there will be costs associated with reviewing 
the information provided by accreditation organizations requesting to 
become an ONC-AA under the permanent certification program. We believe 
that a GS-15 Step 1 employee will review the submissions and the 
National Coordinator (or designated representative) will issue final 
decisions on all submissions. We anticipate that it will take 40 hours 
to review all submissions and reach a final decision on the best 
qualified accreditation organization. This estimate includes the time 
necessary to review the additional documentation that is now required 
to be submitted related to an accreditation organization's proposed 
administration of surveillance by ONC-ACBs and to prepare a briefing 
for the National Coordinator on approving the best qualified ONC-AA. 
This estimate also includes the time of the National Coordinator and 
other senior executive officials devoted to reaching a decision on the 
best qualified ONC-AA. Their time has been included in the 40 hour 
estimate at the GS-15 cost level. We estimate the Federal government's 
overall cost to review the submissions and approve an ONC-AA to be 
$3,226. Based on our estimate of two accreditation organizations 
submitting the required documentation to be considered for ONC-AA 
status and on the requirement that an ONC-AA be selected every three 
years, the annualized cost to the Federal government for reviewing the 
submissions for ONC-AA status will be $1,075. If we notify the public 
of the selection of the ONC-AA by posting the information on our Web 
site and/or by issuing a press release, we believe that we will incur 
negligible costs from these actions.
ii. Application Process for ONC-ACB Status
Costs for Applicant
    Similar to the temporary certification program, an applicant for 
ONC-ACB status will be required to submit an application. However, 
unlike the temporary certification program, an applicant for ONC-ACB 
status must be accredited in order to be a qualified ONC-ACB applicant. 
As specified in the Proposed Rule, we estimate that there will be 6 
applicants for ONC-ACB status under the permanent certification program 
and that those 6 applicants will first seek and become accredited by an 
ONC-AA. Because accreditation will include a demonstration of 
conformance to Guide 65 for all organizations that seek to be 
accredited, we do not believe that there will be a difference in the 
cost of accreditation for organizations who seek to become ONC-ACBs for 
EHR Modules versus ONC-ACBs for Complete EHRs.
    Based on our consultations with NIST, we estimate that it will take 
approximately 2 to 5 days for an ONC-AA to complete the accreditation 
process. We anticipate that accreditation applicants with incur an 
estimated $5,000 administrative fee and the cost of the accreditation 
assessment will be approximately $15,000. In response to public 
comment, we have calculated a cost for the staff time necessary to 
prepare and participate in the accreditation assessment. We have 
accepted the commenter's suggestion that 200 hours of staff time is 
appropriate to attribute to preparation and participation in the 
accreditation assessment and have calculated the corresponding cost for 
this time based on the assumption that an employee equivalent to a 
Federal GS-15 employee would be responsible for preparation and 
participation in the accreditation assessment. A GS-15 employee's 
hourly wage with benefits is approximately $80.65. Therefore, the 
estimated staff cost for accreditation is $16,130.
    We expect that the accreditation renewal process will occur once 
between 2012 and 2016 for each ONC-ACB and assume that the 
accreditation renewal process will be less onerous than the initial 
accreditation process because an ONC-ACB will be able to rely on the 
information it previously prepared for its initial accreditation as 
well as any such information it has produced during the ongoing 
maintenance of its accreditation. Additionally, because the estimated 
number of organizations that could become an ONC-AA is small, we 
believe that it is reasonable to assume that the ONC-ACB would be 
accredited by the same ONC-AA and thus a completely new review of the 
ONC-ACB may not be necessary. We believe a completely new review would 
likely not be necessary because the ONC-AA will already be familiar 
with the ONC-ACB and have its documentation on file, and we do not 
expect that an ONC-ACB will make such drastic changes to its policies 
or procedures which will necessitate a lengthy assessment of their 
competency by an ONC-AA.
    We estimate that it will take no more than 3 days to conduct the 
accreditation renewal process and that the accreditation assessment 
will cost $10,000. In addition, we have similarly added a cost estimate 
to account for staff time to prepare and participate in the 
accreditation renewal process. As with our other renewal cost 
estimates, we anticipate that a reduced amount of staff time will be 
required. We have estimated that an employee equivalent to a GS-15 
Federal employee will be responsible for preparation and participation 
in the accreditation renewal process and that no more than 100 hours of 
the employee's time will be required. As noted, a GS-15 employee's 
hourly wage with benefits is approximately $80.65. Therefore, the 
estimated staff cost for an accreditation renewal assessment is $8,065.
    The total estimated cost for an ONC-ACB to become accredited is 
$36,130 and the total estimated cost for it to renew its accreditation 
is $18,065. These estimated costs are expressed in Table 4 below.
    After becoming accredited by an ONC-AA, an applicant for ONC-ACB

[[Page 1317]]

status will incur minimal costs to prepare and submit an application to 
the National Coordinator. As noted in the collection of information 
section, we believe that it will take 10 minutes to provide the general 
information requested in the application, 30 minutes to assemble the 
information necessary to provide documentation of accreditation by an 
ONC-AA, and 20 minutes to review and agree to the ``Principles of 
Proper Conduct for ONC-ACBs.'' We believe that these time estimates 
will also hold true when applying to renew ONC-ACB status.
    Based on our consultations with NIST, we believe that an employee 
equivalent to the Federal Salary Classification of GS-9 Step 1 could 
provide the required general identifying information and documentation 
of accreditation status. We believe that an employee equivalent to the 
Federal Salary Classification of GS-15 Step 1 would be responsible for 
reviewing and agreeing to the ``Principles of Proper Conduct for ONC-
ACBs.'' We have taken these employee assumptions and utilized the 
corresponding employee hourly rates for the locality pay area of 
Washington, DC, as published by the OPM, to calculate our cost 
estimates. We have also calculated the costs of an employee's benefits 
while completing the application. We have calculated these costs by 
assuming that an applicant expends thirty-six percent (36%) of an 
employee's hourly wage on benefits for the employee. We have concluded 
that a 36% expenditure on benefits is an appropriate estimate because 
it is the routine percentage used by HHS for contract cost estimates. 
We believe that these same assumptions hold true for applying to renew 
ONC-ACB status. Our cost estimates are expressed in Table 3 below.

 Table 3--Permanent Certification Program: Cost to Applicants To Apply To Become ONC-ACBs and Cost for ONC-ACBs
                                           To Apply for Status Renewal
----------------------------------------------------------------------------------------------------------------
                                                                     Employee         Cost of
          Requirement               Employee       Burden hours     hourly wage    employee ben-     Cost per
                                   equivalent                          rate       efits per hour     applicant
----------------------------------------------------------------------------------------------------------------
General Identifying             GS-9 Step 1.....           10/60          $22.39           $8.06           $5.07
 Information.
Documentation of Accreditation  GS-9 Step 1.....           30/60           22.39            8.06           15.23
Principles of Proper Conduct..  GS-15 Step 1....           20/60           59.30           21.35           26.88
                                                 ---------------------------------------------------------------
    Total Cost per Applicant....................................................................          $47.18
----------------------------------------------------------------------------------------------------------------

    We have estimated the applicant costs and ONC-ACB renewal costs 
through 2016, but no further, because we believe that it is premature 
to assume how the meaningful use requirements will change when 
incentive payments are no longer available for eligible professionals 
and eligible hospitals under the Medicare EHR incentive program and 
what impact, if any, those potential changes will have on the permanent 
certification program. Using our estimates above, we believe that the 
average initial cost for an applicant to become accredited and apply to 
be an ONC-ACB will be approximately $36,177 and the total cost for all 
6 applicants will be approximately $217,062. We estimate that between 
2012 and 2016 that all applicants will renew their accreditation and 
ONC-ACB status once. As noted, we assume that the costs for an ONC-ACB 
to renew its status with the National Coordinator will be similar in 
burden to its initial application. We believe that the average cost for 
an ONC-ACB to renew its accreditation and ONC-ACB status will be 
approximately $18,112 and the total renewal costs for all ONC-ACBs will 
be approximately $108,672. We estimate that the total costs of the 
accreditation, application and renewal processes under the proposed 
permanent certification program between 2012 and 2016 would be 
approximately $54,289 per applicant/ONC-ACB and approximately $325,734 
for all applicants/ONC-ACBs. Based on our cost estimate timeframe of 5 
years (2012 through 2016), the annualized cost would be $65,147.

  Table 4--Permanent Certification Program: Total Costs of Certification Accreditation, Applying for ONC Certification Authorization, and Accreditation
                                                     and Authorization Renewal Between 2012 and 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Cost to apply
                                                                          Cost of             for          Cost to renew     Cost to       Total cost
                  Anticipated number of applicants                     accreditation     certification     accreditation    renew ONC-    estimate per
                                                                       per applicant     authorization     per applicant    ACB status   applicant/ ONC-
                                                                                         per applicant                                         ACB
--------------------------------------------------------------------------------------------------------------------------------------------------------
6..................................................................           $36,130               $47           $18,065          $47           $54,289
                                                                    ------------------------------------------------------------------------------------
    Total Cost of Accreditation, Application and Renewal..............................................................................          $325,734
--------------------------------------------------------------------------------------------------------------------------------------------------------

Costs to the Federal Government
    We estimate the cost to develop the ONC-ACB application to be $350 
based on the 5 hours of work we believe it will take a Federal Salary 
Classification GS-14 Step 1 employee located in Washington, DC to 
develop an application form. We also anticipate that there will be 
costs associated with reviewing applications under the permanent 
certification program. We expect that a GS-15 Step 1 employee will 
review the applications and the National Coordinator (or designated 
representative) will issue final decisions on all applications. We 
anticipate that it will take approximately 20 hours to review and reach 
a final decision on each application. This estimate assumes a 
satisfactory application (i.e., no formal deficiency notifications) and 
includes the time necessary to verify the information in each 
application and prepare a briefing for the National Coordinator. We 
estimate the cost for the application review process to be $10,392. As 
a result, we estimate the Federal government's overall cost of 
administering the entire application process at approximately $10,742. 
Based on our cost estimate timeframe of 5 years (2012 through 2016), 
the

[[Page 1318]]

annualized cost to the Federal government will be $2,148.
    As previously noted, we will also post the names of applicants 
granted ONC-ACB status on our Web site. We believe that there will be 
minimal cost associated with this action and have calculated the 
potential cost to be approximately $312 on an annual basis for posting 
and maintaining the information on our Web site (a maximum of 6 hours 
of work for a Federal Salary Classification GS-12 Step 1 employee 
located in Washington, DC).
iii. Testing and Certification of Complete EHRs and EHR Modules
    Section 3001(c)(5)(A) of the PHSA indicates that certification is a 
voluntary act; however, due to the fact that the Medicare and Medicaid 
EHR Incentive Programs require eligible professionals and eligible 
hospitals to use Certified EHR Technology in order to qualify for 
incentive payments, we anticipate that Complete EHR and EHR Module 
developers will seek to have their HIT tested and certified under the 
permanent certification program.
    As previously stated in our discussion of the appropriate timeframe 
for estimating costs for the ONC-ACB application process, we estimate 
costs through 2016, but no further, because we believe that it is 
premature to assume how the meaningful use requirements will change 
when incentive payments are no longer available for eligible 
professionals and eligible hospitals under the Medicare EHR incentive 
program. Although CMS intends to promulgate updates to the meaningful 
use stages every 2 years, we assume that there could be more time 
between stages (i.e., greater than 2 years) in years when incentive 
payments are no longer available under the Medicare EHR incentive 
program based on evaluations of earlier meaningful use stages, public 
feedback, and other factors, which could affect when Complete EHRs and/
or EHR Modules would need to be recertified. However, we do expect 
meaningful use requirements between 2012 and 2016 to become more 
demanding and iterate every 2 years. Therefore, we can assume that 
Complete EHRs and EHR Modules will need to be tested and certified 
twice during this time period.
    As specified in the Temporary Certification Program final rule, we 
believe that approximately 93 commercial/open source Complete EHRs and 
50 EHR Modules will be tested and certified to the 2011/2012 
certification criteria adopted by the Secretary. In addition to the 
testing and certification of these Complete EHRs and EHR Modules, we 
anticipate that a percentage of eligible professionals and eligible 
hospitals will themselves incur the costs associated with the testing 
and certification of their self-developed Complete EHR or EHR Module(s) 
to the 2011/2012 certification criteria adopted by the Secretary.
    With respect to the potential for eligible professionals to seek 
testing and certification for a self-developed Complete EHR, DesRoches 
found that only 5% of physicians are in large practices of over 50 
doctors.\4\ Of these large practices, 17% use an ``advanced EHR 
system'' that could potentially be tested and certified if it were 
self-developed (we assume that smaller physician practices do not have 
the resources to self-develop a Complete EHR). We are unaware of any 
reliable data on the number of large practices who may have a self-
developed Complete EHR for which they would seek to be tested and 
certified. As a result, we have developed an estimate based on 
currently available data. We believe that the total number of eligible 
professionals in large practices who both possess an IT staff with the 
resources to develop and support a Complete EHR and would seek to have 
such a self-developed Complete EHR tested and certified will be low--no 
more than 10%. By taking CMS's estimate of approximately 550,000 
eligible professionals (75 FR 44548) we multiply through by the numbers 
above (550,000 x .05 x .17 x .10) and then divide by a practice size of 
at least 50 which yields approximately 9 self-developed Complete EHRs 
designed for an ambulatory setting that could be submitted for testing 
and certification to the 2011/2012 certification criteria adopted by 
the Secretary. Additionally, we believe that a reasonable estimate for 
the number of large practices with the IT staff and resources to self-
develop an EHR Module and that would seek to have such an EHR Module 
tested and certified can also be derived from the calculation above but 
with a few differences. We start with the total number of large 
practices from the calculation above (~94). We then assume an average 
number (1.25) of self-developed EHR Modules for this group of large 
practices and further refine this estimate by providing low and high 
probability assumptions (10% and 70%, respectively) to represent the 
likelihood that any one of these large practices possesses a self-
developed EHR Module that they would seek to have tested and certified. 
Our calculations produce a minimum estimate of 12 and a maximum 
estimate of 82 EHR Modules that may be presented for testing and 
certification to the 2011/2012 certification criteria adopted by the 
Secretary. Given that no commenter provided data to further support 
this estimate, we believe that our maximum number of self-developed EHR 
Modules estimate is generous. While we do not dispute that practice 
sizes smaller than 50 could also possess self-developed EHR Modules, we 
believe those smaller practices will be the exception, not the rule, 
and that separately calculating a total for these smaller practices 
would produce a negligible amount of EHR Modules to add to our overall 
range.
---------------------------------------------------------------------------

    \4\ DesRoches, CM et al. Electronic Health Records in Ambulatory 
Care--A National Survey of Physicians, New England Journal of 
Medicine, July 2008; 359:50-60.
---------------------------------------------------------------------------

    With respect to eligible hospitals, similar to eligible 
professionals, we believe that only large eligible hospitals would have 
the IT staff and resources available to possess a self-developed 
Complete EHR that they would seek to have tested and certified. Again, 
we are unaware of any reliable data on the number of eligible hospitals 
who may have a self-developed Complete EHR for which they would seek to 
be tested and certified. Further, we believe that with respect to EHR 
Modules the probability varies across different types of eligible 
hospitals regarding their IT staff resources and ability to self-
develop an EHR Module and seek to have it tested and certified. As a 
result, we have developed estimates based on currently available data. 
We have based our calculations on the Medicare eligible hospital table 
CMS provided in its final rule (Table 25) (75 FR 44553) which conveys 
hospital IT capabilities according to three levels of adoption by 
hospital size according to the 2008 AHA annual survey. These three 
levels included: (1) Hospitals which had already implemented relatively 
advanced systems that included CPOE systems for medications; (2) 
hospitals which had implemented more basic systems through which lab 
results could be shared, but not CPOE for medications; and (3) 
hospitals starting from a base level either neither CPOE or lab 
reporting. CMS indicated that CPOE for medication standard was chosen 
because expert input indicated that the CPOE standard in the proposed 
meaningful use definition will be the hardest one for hospitals to 
meet.
    As stated above, we believe that only large hospitals (defined in 
Table 25 as those with 400+ beds) would have the IT staff and resources 
to develop, support, and seek the testing and certification of a self-
developed

[[Page 1319]]

Complete EHR. CMS estimated that 379 large hospitals had met either 
``level 1'' or ``level 2.'' As a result, we estimate that approximately 
10% of these large eligible hospitals have a self-developed Complete 
EHR and would seek to have it tested and certified. This equals about 
38 self-developed Complete EHRs that we could expect to be tested and 
certified to the 2011/2012 certification criteria adopted by the 
Secretary. We believe that this estimate is generous and that a good 
portion of the eligible hospitals that would likely seek to qualify for 
incentive payments with self-developed Complete EHRs would only do so 
for meaningful use Stage 1. After meaningful use Stage 1 we anticipate 
that the number of eligible hospitals that would incur the costs of 
testing and certification themselves will go down because the effort 
involved to maintain a Complete EHR may be time and cost prohibitive as 
the Secretary continues to adopt additional certification criteria to 
support future stages of meaningful use.
    With respect to hospital self-developed EHR Modules, we believe the 
probability varies across different types of eligible hospitals (CAHs, 
Small/Medium, and Large) regarding their IT staff resources and ability 
to self-develop EHR Modules. For each hospital type, we have estimated 
a minimum and a maximum number of EHR Modules that we could expect to 
be self-developed and presented for testing and certification to the 
2011/2012 certification criteria adopted by the Secretary. For CAHs, we 
estimate a minimum of 7 and a maximum of 68 EHR Modules. For small and 
medium hospitals, we estimate a minimum of 163 and a maximum of 488. 
For large hospitals, we estimate a minimum of 190 and a maximum of 531. 
Again, we believe that our maximum estimates of self-developed EHR 
Modules are generous; however, to examine how we reached our estimates, 
please review our calculations specified in Table 5 below.

    Table 5--Estimated Number of Self-Developed EHR Modules Designed for an Inpatient Setting Stratified by Type of Eligible Hospital for Testing and
                                     Certification to the 2011/2012 Certification Criteria Adopted by the Secretary
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Average number
                                                                           Percent with    Percent with       of EHR       Miniml number  Maximum number
                Type of eligible hospital                  Number of EHs    EHR Module      EHR Module      Modules, if       of EHR      of EHR Modules
                                                                               (low)          (high)            any           Modules
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAH.....................................................             616               1              10             1.1               7              68
S/M.....................................................            2169               5              15             1.5             163             488
Large...................................................             379              25              70             2.0             190             531
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................            3164  ..............  ..............  ..............             360            1087
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Even though under the permanent certification program the costs for 
testing and certification could presumably be attributed to different 
entities (i.e., testing costs to a NVLAP-accredited testing laboratory 
and certification costs to an ONC-ACB), we have included them together 
in an effort to reflect the overall effect of this final rule. In 
addition, our cost range for the testing and certification of Complete 
EHRs and EHR Modules includes consideration of how the testing and 
certification will be conducted (i.e., by remote testing and 
certification, on-site testing and certification, or at the ONC-ATCB 
and for the complexity of an EHR Module).
    As recited in the Proposed Rule, CCHIT testified on July 19, 2009 
in front of the HIT Policy Committee on the topic of EHR certification, 
including the certification of EHR Modules. CCHIT estimated that ``EHR-
comprehensive'' according to CCHIT certification criteria would have 
testing and certification costs that would range from approximately 
$30,000 to $50,000. CCHIT also estimated that the testing and 
certification of EHR Modules would range from approximately $5,000 to 
$35,000 depending on the scope of the testing and certification. We 
believe that these estimates provide a reasonable foundation and have 
used them for our cost estimates for the temporary certification 
program and as the basis for estimating costs for the permanent 
certification program. However, we assume that competition in the 
testing and certification markets will reduce the costs of testing and 
certification as estimated by CCHIT but we are unable to provide a 
reliable estimate at this time of what the potential reduction in costs 
might be.
    In creating tables 6 through 13 below, we made the following 
assumptions:
    <bullet> The cost for testing and certification will remain the 
same in the permanent certification program as they were in the 
temporary certification program even with the additional requirement of 
surveillance on the part of ONC-ACBs (which we would expect to be 
included in the cost they charge Complete EHR and/or EHR Module 
developers). We believe this is a reasonable assumption because of the 
low and high cost ranges we have estimated.
    <bullet> That testing and certification costs will be unevenly 
distributed across subsequent years. We assume that there will be an 
increase in the year preceding the next stage of meaningful use and a 
decline between stages because Complete EHR and EHR Module developers 
will likely want to have their products certified as soon as possible 
to new standards and certification criteria so that they can be 
available to eligible professionals and hospitals for meaningful use 
purposes. With respect to the peak years for when testing and 
certification costs would most likely occur, we assume that those peak 
years will be 2012 and 2014, the years preceding the proposed start 
dates of meaningful use Stages 2 and 3, respectively. We assume that an 
increase would encompass 85% of the Complete EHRs and EHR Modules to be 
certified, which would represent most, if not all, Complete EHRs and 
EHR Modules previously certified to the 2011/2012 certification 
criteria adopted by the Secretary and that the remaining 15% of testing 
and certification costs for 2013 would likely represent new EHR Module 
entrants to the HIT marketplace and Complete EHR or EHR Module 
developers who were late to get certified.
    <bullet> We assume that commercial/open source Complete EHR 
developers will continue to consolidate due to mergers and acquisitions 
and that this consolidation would occur at a rate of 5% between 
meaningful use stages. Therefore, we believe that fewer commercial/open 
source Complete EHRs will need to be tested and certified prior to each 
meaningful use stage.

[[Page 1320]]

    <bullet> Conversely, we assume that the number of commercial/open 
source-developed EHR Modules that would need to be tested and certified 
to meet associated meaningful use Stage 2 (2013/2014) certification 
criteria and beyond will grow at a rate of 20% between meaningful use 
stages (i.e., based on our prior estimate of 50 EHR Modules between 
2010 and 2012, there would be 10 new modules developed during 2012 and 
during meaningful use Stage 2 to meet certification criteria associated 
with meaningful use Stage 2). We believe our growth rate is reasonable 
because the cost barrier for EHR Modules to enter the market will be 
much less than a Complete EHR. Coupled with the ability of small or 
start-up HIT developers to enter the market we believe that the 
potential of EHR Modules will lead to a constant stream of new entrants 
year after year.
    <bullet> The number of eligible professionals and eligible 
hospitals that incur the testing and certification costs for their 
self-developed Complete EHRs for meaningful use Stage 2 will drop by 
50% in 2012 and another 25% in 2014 and level out after 2014 due to our 
assumption, that by 2014, and the proposed start of meaningful use 
Stage 3, all of the eligible professionals and eligible hospitals who 
still have a self-developed Complete EHR are likely to maintain their 
HIT rather than switch to a commercial product.
    <bullet> The number of eligible professionals and eligible 
hospitals that incur the testing and certification costs for their 
self-developed EHR Modules will remain in the range we have provided 
for testing and certification to the 2011/2012 certification criteria 
adopted by the Secretary. We believe this is the most reliable estimate 
at this time for a couple of reasons. First, we have provided a 
generous maximum estimate of EHR Modules that we believe will be self 
developed and should account for any potential increase in self-
developed EHR Modules during future meaningful use stages. Second, and 
most importantly, we have no information that would suggest a 
particular direction for the market. We see the potential for a variety 
of ways that the market could progress, some of which include multiple 
self-developed EHR Modules being replaced by one commercial/open source 
EHR Module, more self-developed EHR Modules being created, or an 
equilibrium being created by eligible professionals and eligible 
hospitals switching from commercial to self-developed EHR Modules and 
vice versa. Without knowing the direction of the market, we believe 
that our estimated range of EHR Modules for testing and certification 
to the 2011/2012 certification criteria adopted by the Secretary is the 
most appropriate and reliable estimate to use for establishing 
projected testing and certification costs for meaningful use Stages 2 
and 3.
    <bullet> We assume that gap certification, as described in this 
final rule, will likely reduce the costs of certification. However, 
because of unknown variables such as the number of Complete EHRs and 
EHR Modules that will be eligible for gap certification and how readily 
ONC-ACBs will use gap certification, our cost estimates may vary from 
the actual costs for testing and certification to certification 
criteria associated with later stages of meaningful use.
    As previously mentioned, we anticipate that the temporary 
certification program will sunset on December 31, 2011, or on a 
subsequent date that is determined to be appropriate by the National 
Coordinator. Therefore, it is quite possible that the permanent 
certification program could commence at the start of 2012 and ONC-ACBs 
would begin conducting certifications at that time. Taking this into 
consideration, as similarly calculated for the temporary certification 
program costs (75 FR 36201), we have estimated and attributed to the 
permanent certification program's costs the 2012 costs for testing and 
certifying 15% of the overall number of Complete EHRs and EHR Modules 
that could potentially be tested and certified to the 2011/2012 
certification criteria adopted by the Secretary. This 15% 2012 cost for 
testing and certification is represented by 15% of the number of each 
type of Complete EHR and EHR Module we have estimated would be tested 
and certified to the 2011/2012 certification criteria adopted by the 
Secretary multiplied by the appropriate estimated costs for testing and 
certification. The overall cost is expressed in Table 6 below. It 
should be noted that the cost estimates are different than the cost 
estimates expressed in the Temporary Certification Program final rule 
for 2012 because they are based on an increased number of large 
practice groups and eligible hospitals that may self-develop a Complete 
EHR and/or EHR Module as specified in the Medicare and Medicaid EHR 
Incentive Programs final rule (75 FR 44548, 44553).

Table 6--Distributed Total Costs for the Testing and Certification of Complete EHRs and EHR Modules to the 2011/
         2012 Certification Criteria Adopted by the Secretary Under the Permanent Certification Program
----------------------------------------------------------------------------------------------------------------
                                                  Total low cost        Total high cost      Total average cost
         Year                  Ratio                 estimate               estimate              estimate
                                                             ($M)                   ($M)                  ($M)
----------------------------------------------------------------------------------------------------------------
               2012                    15%                   $.95                  $7.46                 $3.30
----------------------------------------------------------------------------------------------------------------

    The following tables represent estimated permanent certification 
program costs for the testing and certification of Complete EHRs and 
EHR Modules to meaningful use (MU) Stages 2 and 3 and include:
    <bullet> MU Stage 2: Commercial/Open Source Complete EHRs and EHR 
Modules--Table 7;
    <bullet> MU Stage 2: Self-developed Complete EHRs--Table 8;
    <bullet> MU Stage 2: Self-developed EHR Modules--Table 9;
    <bullet> MU Stage 3: Commercial/Open Source Complete EHRs and EHR 
Modules--Table 10;
    <bullet> MU Stage 3: Self-developed Complete EHRs--Table 11;
    <bullet> MU Stage 3: Self-developed EHR Modules--Table 12.
    Table 7 illustrates the costs for testing and certification of 
commercial/open source Complete EHRs and EHR Modules to meaningful use 
Stage 2. We have factored in the assumed 5% reduction in the estimated 
number of Complete EHRs presented for meaningful use Stage 1 and 20% 
increase of the estimated number of EHR Modules presented for 
meaningful use Stage 1. That is, we believe there will be approximately 
88 commercial/open source Complete EHRs and 60 EHR Modules that will be 
tested and certified to meaningful use Stage 2.

[[Page 1321]]



Table 7--MU Stage 2: Costs for Testing and Certification of Commercial/Open Source Complete EHR and EHR Module under the Permanent Certification Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Cost per complete EHR/EHR Module  ($M)   Total cost for all complete EHRs/EHR
                                                                Number   -----------------------------------------    Modules over 3-year period ($M)
                            Type                              tested and                                          --------------------------------------
                                                              certified        Low          High       Mid-point       Low          High      Mid-point
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial/Open Source Complete EHR........................           88        $0.03         $0.05         $0.04        $2.64        $4.40        $3.52
Commercial/Open Source EHR Module..........................           60         0.005         0.035         0.02         0.30         2.10         1.20
                                                            --------------------------------------------------------------------------------------------
    Total..................................................          148  ............  ............  ...........         2.94         6.55         4.72
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 8 illustrates the costs for testing and certification of 
eligible professional and eligible hospital self-developed Complete 
EHRs to meaningful use Stage 2. We have factored in the assumed 50% 
reduction of the estimated number of Complete EHRs presented for 
meaningful use Stage 1. That is, we believe there will be approximately 
5 self-developed Complete EHRs for an ambulatory setting and 19 self-
developed Complete EHRs for an inpatient setting that will be tested 
and certified to meaningful use Stage 2.

           Table 8--MU Stage 2: Costs for Testing and Certification of Self-Developed Complete EHRs Under the Permanent Certification Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Cost per complete EHR ($M)       Total cost for all complete EHRs over
                                                                  Number   ---------------------------------------           3-year period ($M)
                             Type                               tested and                                        --------------------------------------
                                                                certified       Low          High      Mid-point       Low          High      Mid-point
--------------------------------------------------------------------------------------------------------------------------------------------------------
Self Developed Complete EHRs Ambulatory Setting..............            5        $0.03        $0.05        $0.04        $0.15        $0.25        $0.20
Self-Developed Complete EHRs Inpatient Setting...............           19         0.03         0.05         0.04         0.57         0.95         0.76
                                                              ------------------------------------------------------------------------------------------
    Total....................................................           23  ...........  ...........  ...........         0.72         1.20         0.96
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 9 illustrates the costs for testing and certification of 
eligible professional and eligible hospital self-developed EHR Modules 
to meaningful use Stage 2. Based on our assumption, the estimated range 
of EHR Modules that will be presented for testing and certification to 
meaningful use Stage 2 will remain the same as for meaningful use Stage 
1. That is, we believe there will be between 12 and 82 self-developed 
EHR Modules for an ambulatory setting attributable to large eligible 
professional practice groups that will be tested and certified to 
meaningful use Stage 2. In addition, we believe there will be between 
360 and 1087 self-developed Complete EHRs for an inpatient setting 
attributable to CAHs, small/medium hospitals, and large hospitals that 
will be tested and certified to meaningful use Stage 2. In total, we 
believe there will be a minimum of 372 and a maximum of 1,169 self-
developed EHR Modules that will be tested and certified to meaningful 
use Stage 2.

            Table 9--MU Stage 2: Costs for Testing and Certification of Self-Developed EHR Modules Under the Permanent Certification Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Cost per EHR Module ($M)         Total cost for all EHR Modules over
                                                                  Number   ---------------------------------------           3-year period ($M)
                  Self-Developed EHR Modules                    tested and                                        --------------------------------------
                                                                certified       Low          High      Mid-point       Low          High      Mid-point
--------------------------------------------------------------------------------------------------------------------------------------------------------
Min number of EHR Modules....................................          372       $0.005       $0.035        $0.02        $1.86       $13.02        $7.44
Max number of EHR Modules....................................        1,169        0.005        0.035         0.02         5.85        40.92        23.38
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 10 illustrates the costs for testing and certification of 
commercial/open source Complete EHRs and EHR Modules to meaningful use 
Stage 3. We have factored in the assumed 5% reduction in the estimated 
number of Complete EHRs presented for meaningful use Stage 2 and 20% 
increase in the estimated number of EHR Modules presented for 
meaningful use Stage 2. That is, we believe there will be approximately 
84 commercial/open source Complete EHRs and 72 EHR Modules that will be 
tested and certified to meaningful use Stage 3.

[[Page 1322]]



   Table 10--MU Stage 3: Costs for Testing and Certification of Commercial/Open Source Complete EHRs and EHR Modules Under the Permanent Certification
                                                                         Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Cost per complete EHR/EHR Module ($M)   Total cost for all complete EHRs/EHR
                                                                  Number   ---------------------------------------    Modules over 3-year period ($M)
                             Type                               tested and                                        --------------------------------------
                                                                certified       Low          High      Mid-point       Low          High      Mid-point
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial/Open Source Complete EHR..........................           84        $0.03        $0.05        $0.04        $2.52        $4.20        $3.36
Commercial/Open Source EHR Module............................           72        0.005        0.035         0.02         0.36         2.52         1.44
                                                              ------------------------------------------------------------------------------------------
    Total....................................................          156  ...........  ...........  ...........         2.88         6.72         4.80
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 11 illustrates the costs for testing and certification of 
eligible professional and eligible hospital self-developed Complete 
EHRs to meaningful use Stage 3. We have factored in the assumed 25% 
reduction in the estimated number of Complete EHRs presented for 
meaningful use Stage 2. That is, we believe there will be approximately 
4 self-developed Complete EHRs for an ambulatory setting and 14 self-
developed Complete EHRs for an inpatient setting that will be tested 
and certified to meaningful use Stage 3.

           Table 11--MU Stage 3: Costs for Testing and Certification of Self-Developed Complete EHRs Under the Permanent Certification Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Cost per complete EHR ($M)       Total cost for all complete EHRs over
                                                                  Number   ---------------------------------------           3-year period ($M)
                             Type                               tested and                                        --------------------------------------
                                                                certified       Low          High      Mid-point       Low          High      Mid-point
--------------------------------------------------------------------------------------------------------------------------------------------------------
Self Developed Complete EHRs Ambulatory Setting..............            4        $0.03        $0.05        $0.04        $0.12        $0.20        $0.16
Self-Developed Complete EHRs Inpatient Setting...............           14         0.03         0.05         0.04         0.42          .70          .56
                                                              ------------------------------------------------------------------------------------------
    Total....................................................           18  ...........  ...........  ...........         0.54          .90         0.72
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 12 illustrates the costs for testing and certification of 
eligible professional and eligible hospital self-developed EHR Modules 
to meaningful use Stage 3. Based on our assumption, the estimated range 
of EHR Modules that will be presented for testing and certification to 
meaningful use Stage 3 will remain the same as it did for meaningful 
use Stages 1 and 2. That is, we believe there will be between 12 and 82 
self-developed EHR Modules for an ambulatory setting attributable to 
large eligible professional practice groups that will be tested and 
certified to meaningful use Stage 3. In addition, we believe there will 
be between 360 and 1087 self-developed Complete EHRs for an inpatient 
setting attributable to CAHs, small/medium hospitals, and large 
hospitals that will be tested and certified to meaningful use Stage 3. 
In total, we believe there will be a minimum of 372 and a maximum of 
1,169 minimum self-developed EHR Modules that will be tested and 
certified to meaningful use Stage 3.

            Table 12--MU Stage 3: Costs for Testing and Certification of Self-Developed EHR Modules Under the Permanent Certification Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Cost per complete EHR Module ($M)     Total cost for all EHR Modules over
                                                                  Number   ---------------------------------------           3-year period ($M)
                  Self-developed EHR Modules                    tested and                                        --------------------------------------
                                                                certified       Low          High      Mid-point       Low          High      Mid-point
--------------------------------------------------------------------------------------------------------------------------------------------------------
Min number of EHR Modules....................................          372       $0.005       $0.035        $0.02        $1.86       $13.02        $7.44
Max number of EHR Modules....................................        1,169        0.005        0.035         0.02         5.85        40.92        23.38
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 13 illustrates the 85% and 15% testing and certification cost 
distributions we estimate would be attributable to meaningful use 
Stages 2 and 3 (i.e., between 2012 and 2016) under the permanent 
certification program. Additionally, we assume that 100% of self-
developed Complete EHRs and EHR Modules would be certified in year that 
precedes the next meaningful use stage (i.e., 2012 and 2014) because 
eligible professionals and eligible hospitals who remain self-
developers will be motivated to ensure that their HIT can meet the 
definition of Certified EHR Technology prior to the beginning of a new 
meaningful use stage in order to avoid missing out on the incentives or 
being subject to downward payment adjustments. As a result, the costs 
for self-developers to get their Complete EHRs or EHR Modules are only 
attributed in Table 13 to the years 2012 and 2014. The totals 
multiplied by their respective percentages are derived from the tables 
above.

[[Page 1323]]



 Table 13--Estimated Distributed Yearly Costs for the Testing and Certification of Complete EHRs and EHR Modules
             Associated With Meaningful Use Stages 2 and 3 Under the Permanent Certification Program
----------------------------------------------------------------------------------------------------------------
    Meaningful Use State and                                                               Mid-point
            Year(s)              Percentage      Type         Low  ($M)       High  ($M)      ($M)
-----------------------------------------------------------------------------------------------------
Stage 2:
    2012.......................         85   Commercial/  $2.50............        $5.57        $4.01
                                       100   Open Source  2.58.............        42.12        16.37
                                                   SElf-
                                               Developed
    2013/2014..................         15   Commercial/  0.44.............         0.98          .71
                                         0   Open Source  0................            0            0
                                                   Self-
                                               Developed
Stage 3:
    2014.......................         85   Commercial/  2.45.............         5.71         4.08
                                       100   Open Source  2.40.............        41.82        16.13
                                                   Self-
                                               Developed
    2015/2016..................         15   Commercial/  0.43.............         1.01         0.72
                                         0    OpenSource  0................            0            0
                                                   Self-
                                               Developed
----------------------------------------------------------------------------------------------------------------

iv. Costs for Collecting, Storing, and Reporting Certification Results
Costs to ONC-ACBs
    Under the permanent certification program, ONC-ACBs will be 
required to provide ONC, no less frequently than weekly, an up-to-date 
list of Complete EHRs and/or EHR Modules that have been tested and 
certified as well as certain minimum information about each certified 
Complete EHR and/or EHR Module.
    As stated in the collection of information section, we will require 
the reporting of this information on a weekly basis and that it will 
take ONC-ACBs about an hour to prepare and electronically transmit the 
information to ONC each week (i.e., respondents will respond 52 times 
per year). As also noted in the collection of information section and 
consistent with the Temporary Certification Program final rule, we have 
specified in this final rule two additional reporting elements that 
must be submitted by ONC-ACBs on a weekly basis (i.e., clinical quality 
measures to which a Complete EHR or EHR Module has been tested and 
certified and, where applicable, any additional software a Complete EHR 
or EHR Module relied upon to demonstrate its compliance with a 
certification criterion or criteria adopted by the Secretary). ONC-ACBs 
will be capturing these additional reporting elements in conjunction 
with the other information we request that they report on a weekly 
basis. Consequently, we do not believe that the reporting of these two 
additional elements will increase the reporting burden or costs for 
ONC-ACBs.
    We believe that an employee equivalent to the Federal 
Classification of GS-9 Step 1 could complete the transmissions of the 
requested information to ONC. We have utilized the corresponding 
employee hourly rate for the locality pay area of Washington, DC, as 
published by OPM, to calculate our cost estimates. We have also 
calculated the costs of the employee's benefits while completing the 
transmissions of the requested information. We have calculated these 
costs by assuming that an ONC-ACB expends thirty-six percent (36%) of 
an employee's hourly wage on benefits for the employee. We have 
concluded that a 36% expenditure on benefits is an appropriate estimate 
because it is the routine percentage used by HHS for contract cost 
estimates. Our cost estimates are expressed in Table 14 below.

                                          Table 14--Annual Costs for an ONC-ACB To Report Certifications to ONC
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Annual burden                        Employee
               Program requirement                        Employee equivalent          hours per ONC-  Employee hourly  benefits hourly   Total cost per
                                                                                            ACB           wage rate           cost           ONC-ACB
--------------------------------------------------------------------------------------------------------------------------------------------------------
ONC-ACB Certification Results...................  GS-9 Step 1.......................              52           $22.39            $8.06        $1,583.40
--------------------------------------------------------------------------------------------------------------------------------------------------------

    To estimate the highest possible cost, we assume that all of the 
estimated applicants (i.e., six) that we anticipate will apply under 
the permanent certification program will become ONC-ACBs. Therefore, we 
estimate the total annual reporting cost under the permanent 
certification program to be $9,500.40.
Costs to the Federal Government
    As stated previously in this final rule, we will post a 
comprehensive list of all certified Complete EHRs and EHR Modules on 
our Web site. We believe that there will be minimal cost associated 
with this action and have calculated the potential cost, including 
weekly updates, to be $10,784 on an annualized basis. This amount is 
based on 208 hours of yearly work of a Federal Salary Classification 
GS-12 Step 1 employee located in Washington, DC

[[Page 1324]]

v. Costs for Retaining Certification Records
    We stated in the Proposed Rule that we believe that the requirement 
for ONC-ACBs to retain certification records for five years, as 
specified in Sec.  170.523(g), is in line with common industry 
practices and, consequently, does not represent additional costs to 
ONC-ACBs. This determination was based on our consultations with NIST. 
We did not receive any public comments contrary to our determination 
and continue to adhere to our determination.
vi. Submission of Surveillance Plan and Surveillance Results
Costs to ONC-ACBs
    Under the permanent certification program, ONC-ACBs will be 
required to submit an annual surveillance plan to the National 
Coordinator and annually report to the National Coordinator their 
surveillance results.
    As stated in the collection of information section, we anticipate 
that the burden for each ONC-ACB will be the same based on the 
following assumptions. We assume that all surveillance plans will be 
fairly comparable. We also assume that all ONC-ACBs will, on average, 
have a similar burden in submitting results. Finally, we assume that an 
ONC-ACB will submit a copy of their annual surveillance plan and 
surveillance results by either electronic transmission or paper 
submission. In either instance, we believe that an ONC-ACB will spend a 
similar amount of time and effort in organizing, categorizing and 
submitting the requested information. Therefore, we estimate that an 
ONC-ACB will annually allocate 1 hour to submit the surveillance plan 
and 1 hour to submit the surveillance results.
    We believe that an employee equivalent to the Federal 
Classification of GS-9 Step 1 could complete the transmissions of the 
surveillance plan and surveillance results to ONC. We have utilized the 
corresponding employee hourly rate for the locality pay area of 
Washington, DC as published by OPM, to calculate our cost estimates. We 
have also calculated the costs of the employee's benefits while 
completing the transmissions of the surveillance plan and surveillance 
results. We have calculated these costs by assuming that an ONC-ACB 
expends thirty-six percent (36%) of an employee's hourly wage on 
benefits for the employee. We have concluded that a 36% expenditure on 
benefits is an appropriate estimate because it is the routine 
percentage used by HHS for contract cost estimates. Our cost estimates 
are expressed in Table 15 below.

                              Table 15--Annual Costs for an ONC-ACB To Submit a Surveillance Plan and Surveillance Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Annual burden                        Employee
               Program requirement                        Employee equivalent          hours per ONC-  Employee hourly  benefits hourly   Total cost per
                                                                                            ACB           wage rate           cost           ONC-ACB
--------------------------------------------------------------------------------------------------------------------------------------------------------
ONC-ACB Surveillance Plan and Surveillance        GS-9 Step 1.......................               2           $22.39            $8.06           $60.90
 Results.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    To estimate the highest possible cost, we assume that all of the 
estimated applicants (i.e., six) that we anticipate will apply under 
the permanent certification program will become ONC-ACBs. Therefore, we 
estimate the total annual costs for submitting surveillance plans and 
surveillance results will be $365.40.
Costs to the Federal Government
    We believe that we will incur negligible costs in receiving ONC-
ACBs' transmissions of surveillance plans and surveillance results.
vii. Overall Average Annual Costs by Entity
    The following table provides a summary of our overall estimated 
annual costs for the entities that we project will incur costs under 
the permanent certification program (as specified in the RIA of this 
final rule). For ONC-AA applicants, we have averaged the application 
costs over a 3-year period because the duration of an ONC-AA's term is 
3 years. For ONC-ACB applicants, we have averaged the application costs 
over a 5-year period to coincide with the timeframe used to estimate 
testing and certification costs for this final rule. In estimating the 
overall annual costs for an ONC-ACB, we averaged the estimated costs of 
ONC-ACB status renewal over a 3-year period because the duration of an 
ONC-ACB's term is 3 years. For commercial, open source and self-
developers, we have provided the average of the mid-point estimated 
costs for the testing and certification of Complete EHRs and EHR 
Modules to certification criteria associated with meaningful use stages 
2 and 3 over a 5-year period (see also Table 13). Estimated annual 
costs for the Federal government are averaged over the appropriate 
timeframe. For example, costs for reviewing and approving an ONC-AA are 
averaged over a 3-year period, while costs for reviewing ONC-ACB 
applications are averaged over a 5-year period. Table 16 is expressed 
in thousands of dollars ($1,000). To illustrate, $27 is expressed as 
.027 and $6.5 million is expressed as $6,500.00.

                              Table 16--Overall Average Annual Costs for Entities Under the Permanent Certification Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Commercial/open
  ONC-AA applicant           ONC-AA           ONC-ACB applicant          ONC-ACB          source developers      Self-developers     Federal  Government
--------------------------------------------------------------------------------------------------------------------------------------------------------
             .027                   N/A                  7.24                  7.68              1,900.00              6,500.00                 14.32
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Costs are expressed in thousands of dollars ($1,000).

b. Permanent Certification Program Benefits
    We believe that several benefits will accrue from the establishment 
of the permanent certification program. The permanent certification 
program will provide a stable, consistent and reliable program for the 
certification of Complete EHRs, EHR Modules and potentially other types 
of HIT. The permanent certification program will allow eligible 
professionals and eligible hospitals to adopt and implement Certified 
EHR Technology for future

[[Page 1325]]

meaningful use stages, such as Stages 2 and 3, and thus potentially 
qualify for incentive payments under the CMS Medicare and Medicaid EHR 
Incentive Programs. We further believe that the permanent certification 
program will meet our overall goals of accelerating health IT adoption 
and increasing levels of interoperability. At this time, we cannot 
predict how fast all of these savings will occur or their precise 
magnitude as they are partly dependent on future final rules for 
meaningful use and the subsequent standards and certification criteria 
adopted by the Secretary.

D. Regulatory Flexibility Act

    The RFA requires agencies to analyze options for regulatory relief 
of small businesses if a rule has a significant impact on a substantial 
number of small entities. For more information on the Small Business 
Administration's (SBA's) size standards, see the SBA's Web site.\5\ For 
purposes of the RFA, small entities include small businesses, nonprofit 
organizations, and small governmental jurisdictions. When conducting a 
RFA we are required to assess the potential effects of our rule on 
small entities and to make every effort to minimize the regulatory 
burden that might be imposed on small entities. We believe that the 
entities that are likely to be directly affected by this final rule are 
applicants for ONC-ACB status. Furthermore, we believe that these 
entities would either be classified under the North American Industry 
Classification System (NAICS) codes 541380 (Testing Laboratories) or 
541990 (Professional, Scientific and Technical Services).\6\ We believe 
that there will be up to 6 applicants for ONC-ACB status. According to 
the NAICS codes identified above, this would mean SBA size standards of 
$12 million and $7 million in annual receipts, respectively.\7\ Because 
this segment of the HIT industry is in a nascent stage and is comprised 
of very few entities, we have been unable to find reliable data from 
which to determine what realistic annual receipts would be. However, 
based on our total estimates for Complete EHRs and EHR Modules to be 
tested and certified, we assume that the annual receipts of any one 
ONC-ACB could be in the low millions of dollars. Moreover, it is 
unclear, whether these entities may be involved in other testing and 
certification programs which would increase their annual receipts and 
potentially place them outside the SBA's size standards.
---------------------------------------------------------------------------

    \5\ http://sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf.
    \6\ See 13 CFR 121.201.
    \7\ The SBA references that annual receipts means ``total 
income'' (or in the case of a sole proprietorship, ``gross income'') 
plus ``cost of goods sold'' as these terms are defined and reported 
on Internal Revenue Service tax return forms. http://www.sba.gov/idc/groups/public/documents/sba_homepage/guide_to_size_standards.pdf.
---------------------------------------------------------------------------

    We believe that we have established the minimum amount of 
requirements necessary to accomplish our policy goals and that no 
appropriate regulatory alternatives could be developed to lessen the 
compliance burden for applicants for ONC-ACB status as well as ONC-ACBs 
once they have been granted such status by the National Coordinator. 
Moreover, we believe that this final rule will create direct positive 
effects for entities because their attainment of ONC-ACB status will 
permit them to test and certify Complete EHRs, EHR Modules, and/or 
possibly other types of HIT. Thus, we expect that their annual receipts 
will increase as a result of becoming an ONC-ACB.
    We did not receive any comments related to our RFA analysis on the 
permanent certification program. As a result, we examined the economic 
implications of this final rule and have concluded that it will not 
have a significant impact on a substantial number of small entities. 
The Secretary certifies that this final rule will not have a 
significant impact on a substantial number of small entities.

E. Executive Order 13132--Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on State and local governments, preempts State 
law, or otherwise has federalism implications.
    Nothing in this final rule imposes substantial direct requirement 
costs on State and local governments, preempts State law or otherwise 
has federalism implications. We are not aware of any State laws or 
regulations that conflict with or are impeded by our permanent 
certification program, and we did not receive any comments to the 
contrary in response to the Proposed Rule.

F. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires cost-benefit and other analyses before any rulemaking if 
the rule includes a ``Federal mandate that may result in the 
expenditure by State, local, and Tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any 1 year.'' The current inflation-adjusted 
statutory threshold is approximately $135 million. We did not receive 
any comments related to the permanent certification program on our 
analysis presented in the Proposed Rule. Therefore, we have determined 
that this final rule will not constitute a significant rule under the 
Unfunded Mandates Reform Act, because it imposes no mandates.
    OMB reviewed this final rule.

List of Subjects in 45 CFR Part 170

    Computer technology, Electronic health record, Electronic 
information system, Electronic transactions, Health, Health care, 
Health information technology, Health insurance, Health records, 
Hospitals, Incorporation by reference, Laboratories, Medicaid, 
Medicare, Privacy, Reporting and recordkeeping requirements, Public 
health, Security.

0
For the reasons set forth in the preamble, 45 CFR subtitle A, 
subchapter D, part 170, is amended as follows:

PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION 
SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION 
PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY

0
1. The authority citation for part 170 continues to read as follows:

    Authority:  42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C. 
552.


0
2. Add a new subpart E to part 170 to read as follows:
Subpart E--Permanent Certification Program for HIT
Sec.
170.500 Basis and scope.
170.501 Applicability.
170.502 Definitions.
170.503 Requests for ONC-AA status and ONC-AA ongoing 
responsibilities.
170.504 Reconsideration process for requests for ONC-AA status.
170.505 Correspondence.
170.510 Types of certification.
170.520 Application.
170.523 Principles of proper conduct for ONC-ACBs.
170.525 Application submission.
170.530 Review of application.
170.535 ONC-ACB application reconsideration.
170.540 ONC-ACB status.
170.545 Complete EHR certification.
170.550 EHR Module certification.
170.553 Certification of health information technology other than 
Complete EHRs and EHR Modules.
170.555 Certification to newer versions of certain standards.
170.557 Authorized certification methods.
170.560 Good standing as an ONC-ACB.

[[Page 1326]]

170.565 Revocation of ONC-ACB status.
170.570 Effect of revocation on the certifications issued to 
Complete EHRs and EHR Modules.
170.599 Incorporation by reference.

Subpart E--Permanent Certification Program for HIT


Sec.  170.500  Basis and scope.

    This subpart implements section 3001(c)(5) of the Public Health 
Service Act and sets forth the rules and procedures related to the 
permanent certification program for health information technology (HIT) 
administered by the National Coordinator for Health Information 
Technology.


Sec.  170.501  Applicability.

    This subpart establishes the processes that applicants for ONC-ACB 
status must follow to be granted ONC-ACB status by the National 
Coordinator; the processes the National Coordinator will follow when 
assessing applicants and granting ONC-ACB status; the requirements that 
ONC-ACBs must follow to maintain ONC-ACB status; and the requirements 
of ONC-ACBs for certifying Complete EHRs, EHR Module(s), and other 
types of HIT in accordance with the applicable certification criteria 
adopted by the Secretary in subpart C of this part. It also establishes 
the processes accreditation organizations must follow to request 
approval from the National Coordinator and that the National 
Coordinator in turn will follow to approve an accreditation 
organization under the permanent certification program as well as 
certain ongoing responsibilities for an ONC-AA.


Sec.  170.502  Definitions.

    For the purposes of this subpart:
    Applicant means a single organization or a consortium of 
organizations that seeks to become an ONC-ACB by submitting an 
application for ONC-ACB status to the National Coordinator.
    Deployment site means the physical location where a Complete EHR, 
EHR Module(s) or other type of HIT resides or is being or has been 
implemented.
    Development site means the physical location where a Complete EHR, 
EHR Module(s) or other type of HIT was developed.
    Gap certification means the certification of a previously certified 
Complete EHR or EHR Module(s) to:
    (1) All applicable new and/or revised certification criteria 
adopted by the Secretary at subpart C of this part based on the test 
results of a NVLAP-accredited testing laboratory; and
    (2) All other applicable certification criteria adopted by the 
Secretary at subpart C of this part based on the test results used to 
previously certify the Complete EHR or EHR Module(s).
    ONC-Approved Accreditor or ONC-AA means an accreditation 
organization that the National Coordinator has approved to accredit 
certification bodies under the permanent certification program.
    ONC-Authorized Certification Body or ONC-ACB means an organization 
or a consortium of organizations that has applied to and been 
authorized by the National Coordinator pursuant to this subpart to 
perform the certification of Complete EHRs, EHR Module(s), and/or other 
types of HIT under the permanent certification program.
    Providing or provide an updated certification means the action 
taken by an ONC-ACB to ensure that the developer of a previously 
certified EHR Module(s) shall update the information required by Sec.  
170.523(k)(1)(i), after the ONC-ACB has verified that the certification 
criterion or criteria to which the EHR Module(s) was previously 
certified have not been revised and that no new certification criteria 
adopted for privacy and security are applicable to the EHR Module(s).
    Remote certification means the use of methods, including the use of 
web-based tools or secured electronic transmissions, that do not 
require an ONC-ACB to be physically present at the development or 
deployment site to conduct certification.


Sec.  170.503  Requests for ONC-AA status and ONC-AA ongoing 
responsibilities.

    (a) The National Coordinator may approve only one ONC-AA at a time.
    (b) Submission. The National Coordinator will publish a notice in 
the Federal Register to announce the 30-day period during which 
requests for ONC-AA status may be submitted. In order to be considered 
for ONC-AA status, an accreditation organization must submit a timely 
request in writing to the National Coordinator along with the following 
information to demonstrate its ability to serve as an ONC-AA:
    (1) A detailed description of the accreditation organization's 
conformance to ISO/IEC17011:2004 (incorporated by reference in Sec.  
170.599) and experience evaluating the conformance of certification 
bodies to ISO/IEC Guide 65:1996 (incorporated by reference in Sec.  
170.599);
    (2) A detailed description of the accreditation organization's 
accreditation, requirements as well as how those requirements would 
complement the Principles of Proper Conduct for ONC-ACBs and ensure the 
surveillance approaches used by ONC-ACBs include the use of consistent, 
objective, valid, and reliable methods;
    (3) Detailed information on the accreditation organization's 
procedures that would be used to monitor ONC-ACBs;
    (4) Detailed information, including education and experience, about 
the key personnel who review organizations for accreditation; and
    (5) Procedures for responding to, and investigating, complaints 
against ONC-ACBs.
    (c) Preliminary selection.
    (1) The National Coordinator is permitted up to 60 days from the 
end of the submission period to review all timely submissions that were 
received and determine which accreditation organization is best 
qualified to serve as the ONC-AA.
    (2) The National Coordinator's determination will be based on the 
information provided, the completeness of an accreditation 
organization's description of the elements listed in paragraph (b) of 
this section, and each accreditation organization's overall 
accreditation experience.
    (3) The accreditation organization that is determined to be the 
best qualified will be notified that it has been selected as the ONC-AA 
on a preliminary basis, subject to the resolution of the 
reconsideration process in Sec.  170.504. All other accreditation 
organizations will be notified that their requests for ONC-AA status 
have been denied. The accreditation organization that is selected on a 
preliminary basis shall not represent itself as the ONC-AA or perform 
accreditation(s) under the permanent certification program unless and 
until it receives written notice from the National Coordinator that it 
has been approved as the ONC-AA on a final basis pursuant to paragraph 
(d) of this section.
    (4) Any accreditation organization that submits a timely request 
for ONC-AA status and is denied may request reconsideration in 
accordance with Sec.  170.504.
    (d) Final approval.
    (1) If the National Coordinator determines that an accreditation 
organization has met the standard specified in Sec.  170.504(b), then 
that organization will be approved as the ONC-AA on a final basis. The 
accreditation organization that was selected as the ONC-AA on a 
preliminary basis pursuant to paragraph (c) of this section will be 
notified of this final decision and cannot request reconsideration or 
further review.

[[Page 1327]]

    (2) If the National Coordinator determines that no accreditation 
organization has met the standard specified in Sec.  170.504(b), then 
the organization that was selected as the ONC-AA on a preliminary basis 
pursuant to paragraph (c) of this section will be approved as the ONC-
AA on a final basis.
    (e) ONC-AA ongoing responsibilities. An ONC-AA must:
    (1) Maintain conformance with ISO/IEC 17011:2004 (incorporated by 
reference in Sec.  170.599);
    (2) In accrediting certification bodies, verify conformance to, at 
a minimum, ISO/IEC Guide 65:1996 (incorporated by reference in Sec.  
170.599) and ensure the surveillance approaches used by ONC-ACBs 
include the use of consistent, objective, valid, and reliable methods;
    (3) Verify that ONC-ACBs are performing surveillance in accordance 
with their respective annual plans; and
    (4) Review ONC-ACB surveillance results to determine if the results 
indicate any substantive non-conformance by ONC-ACBs with the 
conditions of their respective accreditations.
    (f) ONC-AA status.
    (1) An accreditation organization has not been granted ONC-AA 
status unless and until it is notified by the National Coordinator that 
it has been approved as the ONC-AA on a final basis pursuant to 
paragraph (d) of this section.
    (2) An ONC-AA's status will expire not later than 3 years from the 
date its status was granted by the National Coordinator.
    (3) The National Coordinator will accept requests for ONC-AA 
status, in accordance with paragraph (b) of this section, at least 180 
days before the current ONC-AA's status is set to expire.


Sec.  170.504  Reconsideration process for requests for ONC-AA status.

    (a) An accreditation organization that submits a timely request for 
ONC-AA status in accordance with Sec.  170.503 and is denied may 
request reconsideration of the decision to deny its request for ONC-AA 
status.
    (b) Submission requirement. To request reconsideration, an 
accreditation organization is required to submit to the National 
Coordinator, within 15 days of receipt of a denial notice, a written 
statement with supporting documentation contesting the decision to deny 
its request for ONC-AA status. The submission must demonstrate that 
clear, factual errors were made in the review of its request for ONC-AA 
status and that the accreditation organization would have been selected 
as the ONC-AA pursuant to Sec.  170.503(c) if those errors had been 
corrected. If the National Coordinator does not receive an 
accreditation organization's submission within the specified timeframe, 
then its request for reconsideration may be denied.
    (c) Review of submissions. The National Coordinator is permitted up 
to 30 days to review all timely submissions that were received and 
determine whether an accreditation organization has met the standard 
specified in paragraph (b) of this section.
    (d) Decision.
    (1) If the National Coordinator determines that an accreditation 
organization has met the standard specified in paragraph (b) of this 
section, then that organization will be approved as the ONC-AA on a 
final basis. All other accreditation organizations will be notified 
that their requests for reconsideration have been denied.
    (2) Final decision. A reconsideration decision issued by the 
National Coordinator is final and not subject to further review.


Sec.  170.505  Correspondence.

    (a) Correspondence and communication with the National Coordinator 
shall be conducted by e-mail, unless otherwise necessary. The official 
date of receipt of any e-mail between the National Coordinator and an 
accreditation organization requesting ONC-AA status, the ONC-AA, an 
applicant for ONC-ACB status, or an ONC-ACB is the date on which the e-
mail was sent.
    (b) In circumstances where it is necessary for an accreditation 
organization requesting ONC-AA status, the ONC-AA, an applicant for 
ONC-ACB status, or an ONC-ACB to correspond or communicate with the 
National Coordinator by regular or express mail, the official date of 
receipt will be the date of the delivery confirmation.


Sec.  170.510  Types of certification.

    Applicants may seek authorization from the National Coordinator to 
perform the following types of certification:
    (a) Complete EHR certification; and/or
    (b) EHR Module certification; and/or
    (c) Certification of other types of HIT for which the Secretary has 
adopted certification criteria under subpart C of this part.


Sec.  170.520  Application.

    Applicants must include the following information in an application 
for ONC-ACB status and submit it to the National Coordinator for the 
application to be considered complete.
    (a) The type of authorization sought pursuant to Sec.  170.510. For 
authorization to perform EHR Module certification, applicants must 
indicate the specific type(s) of EHR Module(s) they seek authorization 
to certify. If qualified, applicants will only be granted authorization 
to certify the type(s) of EHR Module(s) for which they seek 
authorization.
    (b) General identifying, information including:
    (1) Name, address, city, state, zip code, and Web site of 
applicant; and
    (2) Designation of an authorized representative, including name, 
title, phone number, and e-mail address of the person who will serve as 
the applicant's point of contact.
    (c) Documentation that confirms that the applicant has been 
accredited by the ONC-AA.
    (d) An agreement, properly executed by the applicant's authorized 
representative, that it will adhere to the Principles of Proper Conduct 
for ONC-ACBs.


Sec.  170.523  Principles of proper conduct for ONC-ACBs.

    An ONC-ACB shall:
    (a) Maintain its accreditation;
    (b) Attend all mandatory ONC training and program update sessions;
    (c) Maintain a training program that includes documented procedures 
and training requirements to ensure its personnel are competent to 
certify HIT;
    (d) Report to ONC within 15 days any changes that materially affect 
its:
    (1) Legal, commercial, organizational, or ownership status;
    (2) Organization and management including key certification 
personnel;
    (3) Policies or procedures;
    (4) Location;
    (5) Personnel, facilities, working environment or other resources;
    (6) ONC authorized representative (point of contact); or
    (7) Other such matters that may otherwise materially affect its 
ability to certify HIT.
    (e) Allow ONC, or its authorized agent(s), to periodically observe 
on site (unannounced or scheduled), during normal business hours, any 
certifications performed to demonstrate compliance with the 
requirements of the permanent certification program;
    (f) Provide ONC, no less frequently than weekly, a current list of 
Complete EHRs and/or EHR Modules that have been certified, which 
includes, at a minimum:
    (1) The Complete EHR or EHR Module developer name (if applicable);

[[Page 1328]]

    (2) The date certified;
    (3) The product version;
    (4) The unique certification number or other specific product 
identification;
    (5) The clinical quality measures to which a Complete EHR or EHR 
Module has been certified;
    (6) Where applicable, any additional software a Complete EHR or EHR 
Module relied upon to demonstrate its compliance with a certification 
criterion or criteria adopted by the Secretary; and
    (7) Where applicable, the certification criterion or criteria to 
which each EHR Module has been certified.
    (g) Retain all records related to the certification of Complete 
EHRs and/or EHR Module(s) for a minimum of 5 years;
    (h) Only certify HIT, including Complete EHRs and/or EHR Module(s), 
that has been tested, using test tools and test procedures approved by 
the National Coordinator, by a/an:
    (1) NVLAP-accredited testing laboratory; or
    (2) ONC-ATCB when:
    (i) Certifying previously certified EHR Module(s) if the 
certification criterion or criteria to which the EHR Module(s) was 
previously certified have not been revised and no new certification 
criteria are applicable to the EHR Module(s); or
    (ii) Performing gap certification.
    (i) Submit an annual surveillance plan to the National Coordinator 
and annually report to the National Coordinator its surveillance 
results; and
    (j) Promptly refund any and all fees received for:
    (1) Requests for certification that are withdrawn while its 
operations are suspended by the National Coordinator;
    (2) Certifications that will not be completed as a result of its 
conduct; and
    (3) Previous certifications that it performed if its conduct 
necessitates the recertification of Complete EHRs and/or EHR Module(s);
    (k) Ensure adherence to the following requirements when issuing a 
certification to a Complete EHR and/or EHR Module(s):
    (1) A Complete EHR or EHR Module developer must conspicuously 
include the following on its Web site and in all marketing materials, 
communications statements, and other assertions related to the Complete 
EHR or EHR Module's certification:
    (i) ``This [Complete EHR or EHR Module] is 20[XX]/20[XX] compliant 
and has been certified by an ONC-ACB in accordance with the applicable 
certification criteria adopted by the Secretary of Health and Human 
Services. This certification does not represent an endorsement by the 
U.S. Department of Health and Human Services or guarantee the receipt 
of incentive payments.''; and
    (ii) The information an ONC-ACB is required to report to the 
National Coordinator under paragraph (f) of this section for the 
specific Complete EHR or EHR Module at issue;
    (2) A certification issued to a pre-coordinated, integrated bundle 
of EHR Modules shall be treated the same as a certification issued to a 
Complete EHR for the purposes of paragraph (k)(1) of this section, 
except that the certification must also indicate each EHR Module that 
is included in the bundle; and
    (3) A certification issued to a Complete EHR or EHR Module based 
solely on the applicable certification criteria adopted by the 
Secretary at subpart C of this part must be separate and distinct from 
any other certification(s) based on other criteria or requirements.


Sec.  170.525  Application submission.

    (a) An applicant for ONC-ACB status must submit its application 
either electronically via e-mail (or web submission if available), or 
by regular or express mail.
    (b) An application for ONC-ACB status may be submitted to the 
National Coordinator at any time.


Sec.  170.530  Review of application.

    (a) Method of review and review timeframe.
    (1) Applications will be reviewed in the order they are received.
    (2) The National Coordinator is permitted up to 30 days from 
receipt to review an application that is submitted for the first time.
    (b) Application deficiencies.
    (1) If the National Coordinator identifies an area in an 
application that requires the applicant to clarify a statement or 
correct an error or omission, the National Coordinator may contact the 
applicant to make such clarification or correction without issuing a 
deficiency notice. If the National Coordinator has not received the 
requested information after five days, the National Coordinator may 
issue a deficiency notice to the applicant.
    (2) If the National Coordinator determines that deficiencies in the 
application exist, the National Coordinator will issue a deficiency 
notice to the applicant and return the application. The deficiency 
notice will identify the areas of the application that require 
additional information or correction.
    (c) Revised application.
    (1) An applicant is permitted to submit a revised application in 
response to a deficiency notice. An applicant may request from the 
National Coordinator an extension for good cause of the 15-day period 
provided in paragraph (c)(2) of this section to submit a revised 
application.
    (2) In order for an applicant to continue to be considered for ONC-
ACB status, the applicant's revised application must address the 
specified deficiencies and be received by the National Coordinator 
within 15 days of the applicant's receipt of the deficiency notice, 
unless the National Coordinator grants an applicant's request for an 
extension of the 15-day period based on a finding of good cause. If a 
good cause extension is granted, then the revised application must be 
received by the end of the extension period.
    (3) The National Coordinator is permitted up to 15 days to review a 
revised application once it has been received and may request 
clarification of statements and the correction of errors or omissions 
in a revised application during this time period.
    (4) If the National Coordinator determines that a revised 
application still contains deficiencies, the applicant will be issued a 
denial notice indicating that the applicant cannot reapply for ONC-ACB 
status for a period of six months from the date of the denial notice. 
An applicant may request reconsideration of this decision in accordance 
with Sec.  170.535.
    (d) Satisfactory application.
    (1) An application will be deemed satisfactory if it meets all the 
application requirements, as determined by the National Coordinator.
    (2) The National Coordinator will notify the applicant's authorized 
representative of its satisfactory application and its successful 
achievement of ONC-ACB status.
    (3) Once notified by the National Coordinator of its successful 
achievement of ONC-ACB status, the applicant may represent itself as an 
ONC-ACB and begin certifying health information technology consistent 
with its authorization.


Sec.  170.535  ONC-ACB application reconsideration.

    (a) An applicant may request that the National Coordinator 
reconsider a denial notice only if the applicant can demonstrate that 
clear, factual errors were made in the review of its application and 
that the errors' correction could lead to the applicant obtaining ONC-
ACB status.
    (b) Submission requirement. An applicant is required to submit, 
within 15 days of receipt of a denial notice, a written statement to 
the National

[[Page 1329]]

Coordinator contesting the decision to deny its application and 
explaining with sufficient documentation what factual error(s) it 
believes can account for the denial. If the National Coordinator does 
not receive the applicant's reconsideration request within the 
specified timeframe, its reconsideration request may be rejected.
    (c) Reconsideration request review. If the National Coordinator 
receives a timely reconsideration request, the National Coordinator is 
permitted up to 15 days from the date of receipt to review the 
information submitted by the applicant and issue a decision.
    (d) Decision.
    (1) If the National Coordinator determines that clear, factual 
errors were made during the review of the application and that 
correction of the errors would remove all identified deficiencies, the 
applicant's authorized representative will be notified of the National 
Coordinator's determination and the applicant's successful achievement 
of ONC-ACB status.
    (2) If, after reviewing an applicant's reconsideration request, the 
National Coordinator determines that the applicant did not identify 
factual errors or that the correction of the factual errors would not 
remove all identified deficiencies in the application, the National 
Coordinator may reject the applicant's reconsideration request.
    (3) Final decision. A reconsideration decision issued by the 
National Coordinator is final and not subject to further review.


Sec.  170.540  ONC-ACB status.

    (a) Acknowledgement and publication. The National Coordinator will 
acknowledge and make publicly available the names of ONC-ACBs, 
including the date each was authorized and the type(s) of certification 
each has been authorized to perform.
    (b) Representation. Each ONC-ACB must prominently and unambiguously 
identify the scope of its authorization on its Web site and in all 
marketing and communications statements (written and oral) pertaining 
to its activities under the permanent certification program.
    (c) Renewal. An ONC-ACB is required to renew its status every three 
years. An ONC-ACB is required to submit a renewal request, containing 
any updates to the information requested in Sec.  170.520, to the 
National Coordinator 60 days prior to the expiration of its status.
    (d) Expiration. An ONC-ACB's status will expire three years from 
the date it was granted by the National Coordinator unless it is 
renewed in accordance with paragraph (c) of this section.


Sec.  170.545  Complete EHR certification.

    (a) When certifying Complete EHRs, an ONC-ACB must certify in 
accordance with all applicable certification criteria adopted by the 
Secretary at subpart C of this part.
    (b) An ONC-ACB must provide the option for a Complete EHR to be 
certified solely to the applicable certification criteria adopted by 
the Secretary at subpart C of this part.
    (c) Gap certification. An ONC-ACB may provide the option for and 
perform gap certification of previously certified Complete EHRs.
    (d) Inherited certified status. An ONC-ACB must accept requests for 
a newer version of a previously certified Complete EHR to inherit the 
certified status of the previously certified Complete EHR without 
requiring the newer version to be recertified.
    (1) Before granting certified status to a newer version of a 
previously certified Complete EHR, an ONC-ACB must review an 
attestation submitted by the developer of the Complete EHR to determine 
whether any change in the newer version has adversely affected the 
Complete EHR's capabilities for which certification criteria have been 
adopted.
    (2) An ONC-ACB may grant certified status to a newer version of a 
previously certified Complete EHR if it determines that the 
capabilities for which certification criteria have been adopted have 
not been adversely affected.
    (e) An ONC-ACB that has been authorized to certify Complete EHRs is 
also authorized to certify all EHR Modules under the permanent 
certification program.


Sec.  170.550  EHR Module certification.

    (a) When certifying EHR Module(s), an ONC-ACB must certify in 
accordance with the applicable certification criteria adopted by the 
Secretary at subpart C of this part.
    (b) An ONC-ACB must provide the option for an EHR Module(s) to be 
certified solely to the applicable certification criteria adopted by 
the Secretary at subpart C of this part.
    (c) Gap certification. An ONC-ACB may provide the option for and 
perform gap certification of previously certified EHR Module(s).
    (d) An ONC-ACB may provide an updated certification to a previously 
certified EHR Module(s).
    (e) Privacy and security certification. EHR Module(s) shall be 
certified to all privacy and security certification criteria adopted by 
the Secretary, unless the EHR Module(s) is presented for certification 
in one of the following manners:
    (1) The EHR Modules are presented for certification as a pre-
coordinated, integrated bundle of EHR Modules, which would otherwise 
meet the definition of and constitute a Complete EHR, and one or more 
of the constituent EHR Modules is demonstrably responsible for 
providing all of the privacy and security capabilities for the entire 
bundle of EHR Modules; or
    (2) An EHR Module is presented for certification, and the presenter 
can demonstrate and provide documentation to the ONC-ACB that a privacy 
and security certification criterion is inapplicable or that it would 
be technically infeasible for the EHR Module to be certified in 
accordance with such certification criterion.
    (f) Inherited certified status. An ONC-ACB must accept requests for 
a newer version of a previously certified EHR Module(s) to inherit the 
certified status of the previously certified EHR Module(s) without 
requiring the newer version to be recertified.
    (1) Before granting certified status to a newer version of a 
previously certified EHR Module(s), an ONC-ACB must review an 
attestation submitted by the developer(s) of the EHR Module(s) to 
determine whether any change in the newer version has adversely 
affected the EHR Module(s)' capabilities for which certification 
criteria have been adopted.
    (2) An ONC-ACB may grant certified status to a newer version of a 
previously certified EHR Module(s) if it determines that the 
capabilities for which certification criteria have been adopted have 
not been adversely affected.


Sec.  170.553  Certification of health information technology other 
than Complete EHRs and EHR Modules.

    An ONC-ACB authorized to certify health information technology 
other than Complete EHRs and/or EHR Modules must certify such health 
information technology in accordance with the applicable certification 
criterion or certification criteria adopted by the Secretary at subpart 
C of this part.


Sec.  170.555  Certification to newer versions of certain standards.

    (a) ONC-ACBs may certify Complete EHRs and/or EHR Module(s) to a 
newer version of certain identified minimum standards specified at 
subpart B of this part if the Secretary has accepted a newer version of 
an adopted minimum standard.
    (b) Applicability of an accepted newer version of an adopted 
minimum standard.

[[Page 1330]]

    (1) ONC-ACBs are not required to certify Complete EHRs and/or EHR 
Module(s) according to newer versions of an adopted minimum standard 
accepted by the Secretary until the incorporation by reference 
provision of the adopted version is updated in the Federal Register 
with a newer version.
    (2) Certified EHR Technology may be upgraded to comply with newer 
versions of an adopted minimum standard accepted by the Secretary 
without adversely affecting the certification status of the Certified 
EHR Technology.


Sec.  170.557  Authorized certification methods.

    An ONC-ACB must provide remote certification for both development 
and deployment sites.


Sec.  170.560  Good standing as an ONC-ACB.

    An ONC-ACB must maintain good standing by:
    (a) Adhering to the Principles of Proper Conduct for ONC-ACBs;
    (b) Refraining from engaging in other types of inappropriate 
behavior, including an ONC-ACB misrepresenting the scope of its 
authorization, as well as an ONC-ACB certifying Complete EHRs and/or 
EHR Module(s) for which it does not have authorization; and
    (c) Following all other applicable Federal and State laws.


Sec.  170.565  Revocation of ONC-ACB status.

    (a) Type-1 violations. The National Coordinator may revoke an ONC-
ACB's status for committing a Type-1 violation. Type-1 violations 
include violations of law or permanent certification program policies 
that threaten or significantly undermine the integrity of the permanent 
certification program. These violations include, but are not limited 
to: False, fraudulent, or abusive activities that affect the permanent 
certification program, a program administered by HHS or any program 
administered by the Federal government.
    (b) Type-2 violations. The National Coordinator may revoke an ONC-
ACB's status for failing to timely or adequately correct a Type-2 
violation. Type-2 violations constitute noncompliance with Sec.  
170.560.
    (1) Noncompliance notification. If the National Coordinator obtains 
reliable evidence that an ONC-ACB may no longer be in compliance with 
Sec.  170.560, the National Coordinator will issue a noncompliance 
notification with reasons for the notification to the ONC-ACB 
requesting that the ONC-ACB respond to the alleged violation and 
correct the violation, if applicable.
    (2) Opportunity to become compliant. After receipt of a 
noncompliance notification, an ONC-ACB is permitted up to 30 days to 
submit a written response and accompanying documentation that 
demonstrates that no violation occurred or that the alleged violation 
has been corrected.
    (i) If the ONC-ACB submits a response, the National Coordinator is 
permitted up to 30 days from the time the response is received to 
evaluate the response and reach a decision. The National Coordinator 
may, if necessary, request additional information from the ONC-ACB 
during this time period.
    (ii) If the National Coordinator determines that no violation 
occurred or that the violation has been sufficiently corrected, the 
National Coordinator will issue a memo to the ONC-ACB confirming this 
determination.
    (iii) If the National Coordinator determines that the ONC-ACB 
failed to demonstrate that no violation occurred or to correct the 
area(s) of non-compliance identified under paragraph (b)(1) of this 
section within 30 days of receipt of the noncompliance notification, 
then the National Coordinator may propose to revoke the ONC-ACB's 
status.
    (c) Proposed revocation.
    (1) The National Coordinator may propose to revoke an ONC-ACB's 
status if the National Coordinator has reliable evidence that the ONC-
ACB has committed a Type-1 violation; or
    (2) The National Coordinator may propose to revoke an ONC-ACB's 
status if, after the ONC-ACB has been notified of a Type-2 violation, 
the ONC-ACB fails to:
    (i) To rebut the finding of a violation with sufficient evidence 
showing that the violation did not occur or that the violation has been 
corrected; or
    (ii) Submit to the National Coordinator a written response to the 
noncompliance notification within the specified timeframe under 
paragraph (b)(2) of this section.
    (d) Suspension of an ONC-ACB's operations.
    (1) The National Coordinator may suspend the operations of an ONC-
ACB under the permanent certification program based on reliable 
evidence indicating that:
    (i) The ONC-ACB committed a Type-1 or Type-2 violation; and
    (ii) The continued certification of Complete EHRs, EHR Module(s), 
and/or other types of HIT by the ONC-ACB could have an adverse impact 
on the health or safety of patients.
    (2) If the National Coordinator determines that the conditions of 
paragraph (d)(1) of this section have been met, an ONC-ACB will be 
issued a notice of proposed suspension.
    (3) Upon receipt of a notice of proposed suspension, an ONC-ACB 
will be permitted up to 3 days to submit a written response to the 
National Coordinator explaining why its operations should not be 
suspended.
    (4) The National Coordinator is permitted up to 5 days from receipt 
of an ONC-ACB's written response to a notice of proposed suspension to 
review the response and make a determination.
    (5) The National Coordinator may make one of the following 
determinations in response to the ONC-ACB's written response or if the 
ONC-ACB fails to submit a written response within the timeframe 
specified in paragraph (d)(3) of this section:
    (i) Rescind the proposed suspension; or
    (ii) Suspend the ONC-ACB's operations until it has adequately 
corrected a Type-2 violation; or
    (iii) Propose revocation in accordance with Sec.  170.565(c) and 
suspend the ONC-ACB's operations for the duration of the revocation 
process.
    (6) A suspension will become effective upon an ONC-ACB's receipt of 
a notice of suspension.
    (e) Opportunity to respond to a proposed revocation notice.
    (1) An ONC-ACB may respond to a proposed revocation notice, but 
must do so within 10 days of receiving the proposed revocation notice 
and include appropriate documentation explaining in writing why its 
status should not be revoked.
    (2) Upon receipt of an ONC-ACB's response to a proposed revocation 
notice, the National Coordinator is permitted up to 30 days to review 
the information submitted by the ONC-ACB and reach a decision.
    (f) Good standing determination. If the National Coordinator 
determines that an ONC-ACB's status should not be revoked, the National 
Coordinator will notify the ONC-ACB's authorized representative in 
writing of this determination.
    (g) Revocation.
    (1) The National Coordinator may revoke an ONC-ACB's status if:
    (i) A determination is made that revocation is appropriate after 
considering the information provided by the ONC-ACB in response to the 
proposed revocation notice; or
    (ii) The ONC-ACB does not respond to a proposed revocation notice 
within the specified timeframe in paragraph (e)(1) of this section.
    (2) A decision to revoke an ONC-ACB's status is final and not 
subject to further review unless the National

[[Page 1331]]

Coordinator chooses to reconsider the revocation.
    (h) Extent and duration of revocation.
    (1) The revocation of an ONC-ACB is effective as soon as the ONC-
ACB receives the revocation notice.
    (2) A certification body that has had its ONC-ACB status revoked is 
prohibited from accepting new requests for certification and must cease 
its current certification operations under the permanent certification 
program.
    (3) A certification body that has had its ONC-ACB has its status 
revoked for a Type-1 violation, is not permitted to reapply for ONC-ACB 
status under the permanent certification program for a period of 1 
year.
    (4) The failure of a certification body that has had its ONC-ACB 
status revoked to promptly refund any and all fees for certifications 
of Complete EHRs and EHR Module(s) not completed will be considered a 
violation of the Principles of Proper Conduct for ONC-ACBs and will be 
taken into account by the National Coordinator if the certification 
body reapplies for ONC-ACB status under the permanent certification 
program.


Sec.  170.570  Effect of revocation on the certifications issued to 
Complete EHRs and EHR Module(s).

    (a) The certified status of Complete EHRs and/or EHR Module(s) 
certified by an ONC-ACB that had its status revoked will remain intact 
unless a Type-1 violation was committed that calls into question the 
legitimacy of the certifications issued by the former ONC-ACB.
    (b) If the National Coordinator determines that a Type-1 violation 
occurred that called into question the legitimacy of certifications 
conducted by the former ONC-ACB, then the National Coordinator would:
    (1) Review the facts surrounding the revocation of the ONC-ACB's 
status; and
    (2) Publish a notice on ONC's Web site if the National Coordinator 
believes that Complete EHRs and/or EHR Module(s) were improperly 
certified by the former ONC-ACB.
    (c) If the National Coordinator determines that Complete EHRs and/
or EHR Module(s) were improperly certified, the certification status of 
affected Complete EHRs and/or EHR Module(s) would only remain intact 
for 120 days after the National Coordinator publishes the notice. The 
certification status of affected Complete EHRs and/or EHR Module(s) can 
only be maintained thereafter by being re-certified by an ONC-ACB in 
good standing.


Sec.  170.599  Incorporation by reference.

    (a) Certain material is incorporated by reference into this subpart 
with the approval of the Director of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that 
specified in this section, the Department of Health and Human Services 
must publish notice of change in the Federal Register and the material 
must be available to the public. All approved material is available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Also, it is available for 
inspection at U.S. Department of Health and Human Services, Office of 
the National Coordinator for Health Information Technology, Hubert H. 
Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, 
DC 20201, call ahead to arrange for inspection at 202-690-7151, and is 
available from the source listed below.
    (b) International Organization for Standardization, Case postale 
56, CH[middot]1211, Geneve 20, Switzerland, telephone +41-22-749-01-11, 
http://www.iso.org.
    (1) ISO/IEC 17011:2004 Conformity Assessment--General Requirements 
for Accreditation Bodies Accrediting Conformity Assessment Bodies 
(Corrected Version), February 15, 2005, IBR approved for Sec.  170.503.
    (2) ISO/IEC GUIDE 65:1996--General Requirements for Bodies 
Operating Product Certification Systems (First Edition), 1996, IBR 
approved for Sec.  170.503.
    (3) [Reserved]

    Dated: December 14, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-33174 Filed 1-3-11; 4:15 pm]
BILLING CODE 4150-45-P