[Federal Register Volume 73, Number 15 (Wednesday, January 23, 2008)]
[Notices]
[Pages 3973-3977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information 
Technology (ONC), DHHS


Notice of Availability: Secretarial Recognition of Certain 
Healthcare Information Technology Standards Panel (HITSP) 
Interoperability Specifications as Interoperability Standards for 
Health Information Technology

AGENCY: Office of the National Coordinator for Health Information 
Technology (ONC), DHHS.
    Authority: Executive Order 13335 (``Incentives for the Use of 
Health Information Technology and Establishing the Position of the 
National Health Information Technology Coordinator''), Executive Order 
13410 (``Promoting Quality and Efficient Health Care in Federal 
Government Administered or Sponsored Health Care Programs''), Public 
Law 110-161, (``Consolidated Appropriations Act, 2008''), 42 
U.S.C.1395nn(b)(4), 42 U.S.C. 1302(a), and 42 CFR 411.357(w).
SUMMARY: By publication of this document, we are informing the public 
of the Secretary's recognition of certain Healthcare Information 
Technology Standards Panel (HITSP) ``Interoperability Specifications'' 
as interoperability standards for health information technology. The 
Secretary accepted these HITSP ``Interoperability Specifications'', 
Version 1.2, in December of 2006, and hereby recognizes them as 
interoperability standards in updated versions in January of 2008. The 
list of recognized interoperability standards is provided below and is 
available at http://www.hitsp.org; click on ``HITSP Interoperability 
Specifications HERE'' box.

SUPPLEMENTARY INFORMATION: The Healthcare Information Technology 
Standards Panel (HITSP) was created in 2005 to serve as a cooperative 
partnership between the public and private sectors for the purpose of 
achieving a widely accepted and useful set of standards specifically to 
enable and support widespread interoperability

[[Page 3974]]

among healthcare software systems, as they will interact in a local, 
regional, and the Nationwide Health Information Network in the United 
States.
    Under a contract with the Department of Health and Human Services, 
the American National Standards Institute (ANSI) established HITSP, 
following a neutral and inclusive governance model. The process was 
built by vendors, standards development organizations (SDOs), 
consumers, payers, providers, etc. HITSP is a multi-stakeholder 
organization involving more than 600 different healthcare industry 
organizations and technical experts whose activities to date on these 
Interoperability Specifications represent more than 20,000 volunteer 
hours of effort.
    In March of 2006, HITSP was given three initial priority areas (use 
cases): Consumer Empowerment, Biosurveillance, and Laboratory 
Electronic Health Record Interoperability. HITSP converted those use 
cases into detailed requirements documents and examined more than 700 
standards that would meet those requirements and assessed their 
readiness and appropriateness. From those 700 standards, HITSP 
identified 30 named standards, and produced detailed implementation 
guidance, ``constructs,'' that describe the specific transactions and 
use of these named standards. The Secretary therefore is recognizing 
the ``constructs'' associated with the as interoperability standards to 
clarify the intended use and application of the ``named standards''.
    On October 31, 2006, HITSP presented to the American Health 
Information Community (AHIC) three sets of Interoperability 
Specifications. The AHIC is a Federal Advisory Committee Act (FACA) 
advisory body, chartered in 2005 to make recommendations to the 
Secretary on methods for accelerating the development and adoption of 
health information technology. At the October 31, 2006, AHIC meeting, 
the members discussed the HITSP Interoperability Specifications and 
made the consensus recommendation that the Interoperability 
Specifications be recognized by the Secretary. Secretary Leavitt 
accepted these Interoperability Specifications in December 2006 with 
the intent to recognize them one year later, presuming that any changes 
would be minimal, reflecting public comment and/or of a minor and 
technical nature. On March 1, 2007, the Department published a Notice 
in the Federal Register (72 FR 9339) announcing the Secretary's 
acceptance and planned recognition of certain interoperability 
specifications.
    The HITSP Panel approved the subsequent version of the 
interoperability specifications on May 11, 2007. No additional 
constructs or standards were added as a result of implementation 
testing feedback. All changes were minor or of a technical nature to 
the implementation guidance. On June 12, 2007, HIC presented to 
Secretary Leavitt these completed Interoperability Specifications, 
including 28 of 30 completely balloted named standards and 
implementation guidance in the form of constructs. As detailed below, 
in December 2007, one of the two outstanding named standards passed 
ballot by its SDO; after the designated 6-month waiting period, this 
named standard and two associated constructs will achieve full 
recognition status by the Secretary in June 2008 by the Secretary. The 
final standard is still under ballot.
    The three high level groupings of these interoperability standards 
are as follows.

I. Electronic Health Record (EHR) Laboratory Results Reporting

    The purpose of the EHR interoperability specification is to allow 
ordering clinicians to electronically access laboratory results, and to 
allow non-ordering authorized clinicians to electronically access 
historical and other laboratory results for clinical care. The 
recognized version of the standard addresses the lack of harmonization 
among data interoperability standards including vocabulary and 
laboratory and other messaging standards; it also accommodates both 
laboratory message transaction and document-sharing paradigms. In 
addition, a laboratory message implementation guide has been completed 
to meet AHIC use case requirements. The EHR specification is complete 
and includes all of the implementation guidance necessary to implement 
and the final balloted work products of all the standards development 
organizations involved, with one caveat. The messaging standard for 
laboratories, HL-7 2.5.1, passed ballot in December 2007, with final 
implementation guidance to be incorporated into the HITSP 
specifications. This standard, along with an associated construct, the 
Lab Result Message Component (C36) will achieve full recognition status 
by the Secretary in June 2008.
    The interoperability standards--Interoperability Specification 
including Constructs (Components, Transactions, and Transaction 
Packages) and Named Standards associated with EHR are listed below.

Interoperability Specification Constructs (Components (C), Transactions 
(T), and Transaction Packages (TP)) for EHR

    <bullet> EHR Lab Reporting Interoperability Specification (HITSP 
V2.1 2007 IS01).
    <bullet> Lab Result Terminology Component (HITSP V2.0 2007 C35).
    <bullet> Lab Report Document Component (HITSP V2.0 2007 C37).
    <bullet> Secure Web Connection Component (HITSP V2.0 2007 C44).
    <bullet> View Lab Result From Web App Transaction (HITSP V2.0 2007 
T18).
    <bullet> Patient Demographics Query Transaction (HITSP V2.0 2007 
T23).
    <bullet> Notification of Document Availability Transaction (HITSP 
V2.0 2007 T29).
    <bullet> Manage Sharing of Documents Transaction Package (HITSP 
V2.2 2007 TP13).
    <bullet> Send Lab Result Message Transaction Package (HITSP V2.1 
2007 TP14).
    <bullet> Patient ID Cross-Referencing Transaction Package (HITSP 
V2.0 2007 TP22).

Named Standards for EHR

    <bullet> Portions of the Clinical Laboratory Improvement Amendments 
(CLIA) of 1988 (42 CFR part 493).
    <bullet> Portions of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA)--Administrative Simplification.
    <bullet> Health Level Seven (HL7) Version 2.5.
    <bullet> Health Level Seven (HL7) Version 2.5/2.5.1.
    <bullet> Health Level Seven (HL7) Version 3.0 Clinical Document 
Architecture (CDA/CDA R2).
    <bullet> Hypertext Transfer Protocol Secure (HTTPS) 443/tcp.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 3.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry 
Stored Query Transaction for XDS Profile Supplement.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0 XCA 
Supplement.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (TF)

[[Page 3975]]

Supplement--ITI-25 Notification of Document Availability (NAV) June 28, 
2005.
    <bullet> Integrating the Healthcare Enterprise (IHE) Laboratory 
Technical Framework Supplement 2006-2007 Revision 1.0.
    <bullet> International Health Terminology Standards Development 
Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical 
Terms (SNOMED CT[supreg]).
    <bullet> International Organization for Standardization (ISO) 
Electronic business eXtensible Markup Language (ebXML), Technical 
Specification <greek-i> 15000--Part 4: Registry services specification 
(ebRS), May, 2004.
    <bullet> Logical Observation Identifiers Names and Codes 
(LOINC[supreg]).
    <bullet> Unified Code for Units of Measure (UCUM).

II. Biosurveillance (BIO)

    The purpose of the BIO interoperability specification is to 
transmit essential ambulatory care and emergency department visit, 
utilization, and laboratory result data from electronically enabled 
healthcare delivery and public health systems in standardized and 
anonymized format to authorized Public Health Agencies with less than 
one day lag time. The BIO specification is complete and includes all of 
the implementation guidance necessary to implement and the final 
balloted work products of all the standards development organizations 
involved, with two exceptions. The messaging standard for laboratories, 
HL-7 2.5.1, passed ballot in December 2007, with final implementation 
guidance to be incorporated into the HITSP specifications. This 
standard, along with two associated constructs, the Lab Result Message 
Component (C36) and the Resource Utilization Component (C47), will 
achieve full recognition status by the Secretary in June 2008. The 
Hospital Availability Exchange Standard (HAVE) is still under the SDO 
ballot process.
    The interoperability standards--Interoperability Specification 
including Constructs (Components, Transactions, and Transaction 
Packages) and Named Standards associated with BIO are listed below.

Interoperability Specification Constructs (Components (C), Transactions 
(T), and Transaction Packages (TP)) for BIO

    <bullet> Biosurveillance Interoperability Specification (HITSP V2.1 
2007 IS02).
    <bullet> Anonymize Component (HITSP V2.1 2007 C25).
    <bullet> Lab Result Terminology Component (HITSP V2.0 2007 C35).
    <bullet> Lab Report Document Component (HITSP V2.0 2007 C37).
    <bullet> Encounter Message Component (HITSP V2.0 2007 C39).
    <bullet> Radiology Result Message Component (HITSP V2.0 2007 C41).
    <bullet> Encounter Document Component (HITSP V2.1 2007 C48).
    <bullet> Pseudonymize Transaction (HITSP V2.1 2007 T24).
    <bullet> Notification of Document Availability Transaction (HITSP 
V2.0 2007 T29).
    <bullet> Manage Sharing of Documents Transaction Package (HITSP 
V2.2 2007 TP13).
    <bullet> Patient ID Cross-Referencing Transaction Package (HITSP 
V2.0 2007 TP22).
    <bullet> Sharing Radiology Results Transaction Package (HITSP V2.0 
2007 TP49).
    <bullet> Retrieve Form for Data Capture Transaction Package (HITSP 
V2.1 2007 TP50).

Named Standards for BIO:

    <bullet> American Medical Association (AMA) Current Procedural 
Terminology (CPT[supreg]) Fourth Edition (CPT-4).
    <bullet> Clinical Care Classification (CCC) Version 2.0 [formerly 
known as the Home Healthcare Classification (HHCC) System].
    <bullet> Portions of the Clinical Laboratory Improvement Amendments 
(CLIA) of 1988 (42 CFR part 493).
    <bullet> Digital Imaging and Communications in Medicine (DICOM) 
Attribute Level Confidentiality Supplement: <greek-i> 55.
    <bullet> Federal Information Processing Standards (FIPS) Codes for 
the Identification of the States, the District of Columbia and the 
Outlying Areas of the United States, and Associated Areas Publication 
<greek-i> 5-2, May, 1987.
    <bullet> Portions of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA)--Administrative Simplification.
    <bullet> Health Level Seven (HL7) Version 2.5.
    <bullet> Health Level Seven (HL7) Version 2.5/2.5.1.
    <bullet> Health Level Seven (HL7) Version 3.0.
    <bullet> Health Level Seven (HL7) Version 3.0 Clinical Document 
Architecture (CDA/CDA R2).
    <bullet> Healthcare Common Procedure Coding System (HCPCS) Level II 
Code Set.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 3.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry 
Stored Query Transaction for XDS Profile Supplement.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0 XCA 
Supplement.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (TF) Supplement--ITI-25 Notification 
of Document Availability (NAV) June 28, 2005.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (TF) Supplement--Retrieve Form for 
Data Capture (RFD) Sept 25, 2006.
    <bullet> Integrating the Healthcare Enterprise (IHE) Laboratory 
Technical Framework Supplement 2006-2007 Revision 1.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) Patient Care 
Coordination (PCC) Technical Framework Revision 3.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) Radiology 
Technical Framework Revision 7.0.
    <bullet> International Classification of Diseases, 10th Revision, 
Procedure Coding System (ICD-10-CS).
    <bullet> International Classification of Diseases, 10th Revision, 
Related Health Problems (ICD-10-CM).
    <bullet> International Classification of Diseases, 9th Revision, 
Clinical Modifications (ICD-9-CM).
    <bullet> International Health Terminology Standards Development 
Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical 
Terms (SNOMED CT[supreg]).
    <bullet> International Organization for Standardization (ISO) 
Health informatics--Pseudonymization, Unpublished Technical 
Specification <greek-i> 25237.
    <bullet> International Organization for Standardization (ISO) 
Electronic business eXtensible Markup Language (ebXML), Technical 
Specification <greek-i> 15000--Part 4: Registry services specification 
(ebRS), May, 2004.
    <bullet> Logical Observation Identifiers Names and Codes (LOINC 
[supreg]).
    <bullet> National Library of Medicine (NLM) Unified Medical 
Language System (UMLS) RxNorm.
    <bullet> National Uniform Billing Committee (NUBC) Uniform Bill 
Version 1992 (UB-92) Current UB Data Specification Manual Field 22, 
Patient Discharge Status, Codes.
    <bullet> Organization for the Advancement of Structured Information 
Standards

[[Page 3976]]

 (OASIS) Emergency Data Exchange Language (EDXL) Distribution Element 
(DE).
    <bullet> Unified Code for Units of Measure (UCUM).

III. Consumer Empowerment (CE)

    The purpose of the CE interoperability specification is to allow 
consumers to establish and manage permissions access, rights, and 
informed consent for authorized and secure exchange, viewing, and 
querying of their linked patient registration summaries and medication 
histories between designated caregivers and other health professionals. 
The CE specification is complete and includes all of the implementation 
guidance necessary to implement and the final balloted work products of 
all the standards development organizations involved.
    The interoperability standards--Interoperability Specification 
including Constructs (Components, Transactions, and Transaction 
Packages) and Named Standards associated with CE are listed below.

Interoperability Specification Constructs (Components (C), Transactions 
(T), and Transaction Packages (TP)) for CE

    <bullet> Consumer Empowerment Interoperability Specification (HITSP 
V2.1 2007 IS03).
    <bullet> Summary Documents Using CCD Component (HITSP V2.1 2007 
C32).
    <bullet> Patient Demographics Query Transaction (HITSP V2.0 2007 
T23).
    <bullet> Manage Sharing of Documents Transaction Package (HITSP 
V2.2 2007 TP13).
    <bullet> Patient ID Cross-Referencing Transaction Package (HITSP 
V2.0 2007 TP22).

Named Standards for CE

    <bullet> Accredited Standards Committee (ASC) X12 Insurance 
Subcommittee (X12N) Implementation Guides Version 004010 plus Addenda 
004010A1.
    <bullet> Accredited Standards Committee (ASC) X12 Standards Release 
004010.
    <bullet> American Society for Testing and Materials (ASTM) Standard 
Specification for Coded Values Used in the Electronic Health Record: 
<greek-i> E1633-02.
    <bullet> American Society for Testing and Materials (ASTM) Standard 
Specification for Continuity of Care Record (CCR): <greek-i> E2369-05.
    <bullet> CDC Race and Ethnicity Code Sets.
    <bullet> Council for Affordable Quality Health Care (CAQH) 
Committee on Operating Rules for Information Exchange (CORE) Phase I 
Operating Rules.
    <bullet> Federal Medication Terminologies.
    <bullet> Health Care Provider Taxonomy.
    <bullet> Health Level Seven (HL7) EHR System Functional Model Draft 
Standard for Trial Use (DSTU).
    <bullet> Health Level Seven (HL7) Version 2.5.
    <bullet> Health Level Seven (HL7) Version 2.5/2.5.1.
    <bullet> Health Level Seven (HL7) Version 3.0.
    <bullet> Health Level Seven (HL7) Version 3.0 Clinical Document 
Architecture (CDA/CDA R2).
    <bullet> HL7 Implementation Guide: CDA Release 2--Continuity of 
Care Document (CCD), Release 1.0, April 1, 2007.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 3.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry 
Stored Query Transaction for XDS Profile Supplement.
    <bullet> Integrating the Healthcare Enterprise (IHE) IT 
Infrastructure Technical Framework (ITI-TF) Revision 4.0 XCA 
Supplement.
    <bullet> Integrating the Healthcare Enterprise (IHE) Patient Care 
Coordination (PCC) Technical Framework Revision 3.0.
    <bullet> International Organization for Standardization (ISO) 
Electronic business eXtensible Markup Language (ebXML), Technical 
Specification <greek-i> 15000--Part 4: Registry services specification 
(ebRS), May, 2004.
    <bullet> Logical Observation Identifiers Names and Codes (LOINC 
[supreg]).
    <bullet> National Council for Prescription Drug Programs (NCPDP) 
SCRIPT Standard Version 8.1.
    <bullet> Revisions to the Standards for the Classification of 
Federal Data on Race and Ethnicity.
    We recognize that certain legal obligations may flow from the 
recognition of these interoperability standards. First, pursuant to 
Executive Order 13410 (EO 13410) dated August 22, 2006, recognition of 
interoperability standards would require each Federal health agency, as 
it implements, acquires, or upgrades health information technology 
systems used for the direct exchange of health information between 
agencies and with non-Federal entities, to ``utilize, where available, 
health information technology systems and products that meet 
interoperability standards recognized by the Secretary.'' Therefore, 
Federal agencies would be required to appropriately consider health 
information technology systems and products that comply with these 
Interoperability Specifications when purchasing, implementing, or 
upgrading such items.
    Similarly, the EO 13410 directs Federal agencies to contractually 
require, to the extent permitted by law, certain entities with whom 
they do business, to use, where available, health information 
technology systems and products that meet recognized interoperability 
standards.
    In addition, the regulations promulgated on August 8, 2006 (see 71 
FR 45140 and 71 FR 45110) established exceptions and safe harbors to 
the physician self-referral law and the anti-kickback statute, 
respectively, for certain arrangements involving the donation of 
electronic prescribing and electronic health records (EHR) technology 
and services. The EHR exception and safe harbor require that the 
software be ``interoperable'' as defined in the regulations. The rules 
also provide that certain software will be deemed to be 
``interoperable'' if that software has been certified by a certifying 
body recognized by the Secretary within 12 months prior to the 
donation. Under the interim guidance for the recognition of certifying 
bodies published by the ONC (``Office of the National Coordinator for 
Health Information Technology (ONC) Interim Guidance Regarding the 
Recognition of Certification Bodies''), for an organization to be 
recognized as a recognized certifying body (RCB), the organization 
must:

Have in place a demonstrated process for and experience in certifying 
products to be in compliance with criteria recognized by the Secretary;
Have a method by which they can incorporate all applicable standards 
and certification criteria recognized by the Secretary into their 
certification processes; and
Have the ability to adapt their processes to emerging certification 
criteria recognized by the Secretary.

    The RCBs would therefore have to certify such products in 
conformity with, among other provisions, these interoperability 
specifications for the certified products to meet the interoperability 
deeming provisions of the physician self-referral exception and anti-
kickback safe harbor, respectively.
    The Secretary is mindful that the ability of software to be 
interoperable evolves as technology develops. Consequently, if an 
enforcement action is initiated for an allegedly improper donation of 
EHR non-certified software,

[[Page 3977]]

the Secretary would review whether the software was interoperable, as 
defined in the regulations. The Secretary would consider the prevailing 
state of technology at the time the items or services were provided to 
the recipient. As explained in the regulations, the Secretary 
understands that parties should have a reasonable basis for determining 
whether the EHR software is interoperable. We therefore indicated that 
``it would be appropriate--and, indeed, advisable--for parties to 
consult any standards and criteria related to interoperability 
recognized by the Department.''
    Compliance with these standards and criteria, as we explained in 
the regulations, ``will provide greater certainty to donors and 
recipients that products meet the interoperability requirement, and may 
be relevant in an enforcement action.''
    Based on the changing nature of technological development noted 
above, the Secretary has accepted and recognized these Interoperability 
Specifications. He has also delegated authority to ONC to coordinate 
and oversee the incorporation of these Interoperability Specifications 
in relevant activities among Federal agencies and other partner 
organizations, as appropriate.

FOR FURTHER INFORMATION CONTACT: Judith Sparrow at (202) 690-7151.

    Dated: January 17, 2008.
Robert M. Kolodner,
National Coordinator for Health Information Technology, Office of the 
National Coordinator for Health Information Technology.
[FR Doc. 08-234 Filed 1-17-08; 1:18pm]
BILLING CODE 4150-45-P