Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices 44295 

1HHS notes that the requirements of the HIPAA 

Security Rule continue to be applicable. 

notice is hereby given that the Federal 

Accounting Standards Advisory Board 

(FASAB) has issued an exposure draft, 

Interpretation: Items Held for 

Remanufacture. 

The proposed Interpretation would 

clarify the principles governing the 

classification, valuation and reporting of 

items that are in the process of major 

overhaul or remanufacture for sale or for 

internal use. The Exposure Draft is 

available on the FASAB home page 

http://www.fasab.gov/exposure.html. 

Copies can be obtained by contacting 

FASAB at (202) 512–7350. Respondents 

are encouraged to comment on any 

party of the exposure draft. 

Written comments are requested by 

October 16, 2006, and should be sent to: 

Wendy M. Comes, Executive Director, 

Federal Accounting Standards Advisory 

Board. 441 G Street, NW., Suite 6814, 

Mail Stop 6K17V, Washington, DC 

20548. 

FOR FURTHER INFORMATION CONTACT: 

Wendy Comes, Executive Director, 441 

G Street, NW., Washington, DC 20548, 

or call (202) 512–7350. 

Authority: Federal Advisory Committee 

Act, Pub. L. 92–463. 

Dated: August 1, 2006. 

Charles Jackson, 

Federal Register Liaison Officer. 

[FR Doc. 06–6677 Filed 8–3–06; 8:45 am] 

BILLING CODE 1610–01–M 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR Part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The application also will be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Additional information on all bank 

holding companies may be obtained 

from the National Information Center 

website at www.ffiec.gov/nic/. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than August 31, 

2006. 

A. Federal Reserve Bank of Atlanta 

(Andre Anderson, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30309: 

1. Piedmont Community Bank Group, 

Inc., Gray, Georgia; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Piedmont 

Community Bank, Gray, Georgia. 

Board of Governors of the Federal Reserve 

System, August 1, 2006. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E6–12608 Filed 8–3–06; 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Availability: Secretarial 

Recognition of Certain Certification 

Commission for Healthcare 

Information Technology (CCHIT) 

Functionality, Interoperability, Security 

and Reliability Criteria for Ambulatory 

Electronic Health Records 

AGENCY: Office of the Secretary, HHS. 

Authority: EO 13335 (‘‘Incentives for the 

Use of Health Information Technology and 

Establishing the Position of the National 

Health Information Technology 

Coordinator’’) and Pub. L. 109–149 

(‘‘Departments of Labor, Health and Human 

Services, and Education, and Related 

Agencies Appropriations Act, 2006’’). 

SUMMARY: By this document we are 

informing the public of the Secretary’s 

recognition of certain Certification 

Commission for Healthcare Information 

Technology (CCHIT) criteria for 

ambulatory EHR functionality, 

interoperability, security and reliability 

standards. This list of recognized 

criteria is available by clicking the 

applicable link at http://www.hhs.gov/ 

healthit. 

The CCHIT was created in 2004 by an 

industry coalition of the American 

Health Information Management 

Association (AHIMA), the Health 

Information and Management Systems 

Society (HIMSS) and the National 

Alliance for Health Information 

Technology. CCHIT’s mission is to 

accelerate the adoption of HIT by 

creating an efficient, credible and 

sustainable product certification 

program. 

During the three comment cycles that 

generated the ambulatory EHR criteria 

that the Secretary has recognized, 

CCHIT received over 1500 comments 

from a wide range of stakeholders. 

Further outreach was achieved through 

the establishment of several large Town 

Hall presentations with attendances in 

the range of 500–1000 at Healthcare 

Information Management Systems 

Society (HIMSS) conferences as well as 

at more than thirty smaller 

presentations to a variety of 

associations, organizations and the press 

gatherings. 

CCHIT grouped its ambulatory EHR 

certification criteria recommendations 

into three groups, ‘‘functionality,’’

‘‘interoperability’’ and ‘‘security/ 

reliability.’’ For ease of understanding, 

the Secretary broke the security and 

reliability recommendations into 

separate categories. Definitions of these 

categories, and an example that 

illuminates the various functions of 

each category are as follows: 

1. Functionality criteria identify 

minimum required and provisional 

product features for documenting and 

managing a typical patient encounter. 

For example, a physician needs to be 

able to access his/her patient’s 

laboratory test results, so an example of 

a functional requirement is that an EHR 

would need to provide the capability of 

displaying laboratory test results. 

2. Interoperability criteria establish 

standards for how products interact 

with other products within and across 

care settings. For example, to ensure 

interoperability, the physician EHR 

noted above would need to be able to 

receive laboratory test results from 

another physician’s (within care 

settings) as well as from laboratory 

systems (across care settings). 

3. Security and reliability criteria are 

designed to help the security inspector 

assess a product’s ability to protect, 

manage and audit access to sensitive 

patient data. For clarity, we have broken 

these criteria into the two separate 

categories, security and reliability. 

a. Security 1 addresses the appropriate 

access to data by appropriate parties and 

the protection of data from improper 

manipulation. For example, laboratory 

test results should be accessible to a 


gechino on PROD1PC61 with NOTICES
44296 Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices 

treating physician, but inaccessible to a 

clerical employee who does not need 

such access to accomplish their job. 

Security also involves ensuring that data 

have not been altered or tampered with. 

b. Reliability goes to the accessibility 

and consistency with which data is 

retrieved and displayed. For example, 

the physician should be able to easily 

and consistently access laboratory test 

results through some consistent display 

mechanism that can be counted on to be 

available whenever it is needed. 

At HHS’ request, the CCHITrecommended ambulatory EHR 

certification criteria were presented to 

the American Health Information 

Community (AHIC) on May 16, 2006. 

After consideration, the AHIC 

recommended that the Secretary 

recognize CCHIT identified ambulatory 

EHR certification criteria that CCHIT 

recommended for use in 2006. This 

recommendation informed the 

Secretary’s decision to recognize these 

criteria. 

The Secretary also based his decision 

to recognize these criteria on the need 

for such criteria in the Departments 

recently published final rules for 

exceptions to the physician self-referral 

law and safe harbors to the Antikickback statute for electronic 

prescribing and EHR arrangements (RIN 

#0938–AN69 and 0991–AB36 

respectively). These rules are premised 

on: 

1. HHS having recognized one or 

more EHR certifying bodies, and 

2. HHS having recognized criteria for 

the certification of EHRs. 

A separate notice of availability has 

been published in the Federal Register 

to notify the public about the 

availability of a certification Guidance 

Document that provides interim 

guidance on the recognition of 

certification bodies. This document is 

also available at http://www.hhs.gov/ 

healthit. The CCHIT criteria that the 

Secretary has recognized serve to 

establish the initial EHR certification 

criteria that are referenced in the final 

physician self-referral law and Antikickback statute rules. 

The Secretary also based his decision 

to recognize the CCHIT criteria on a 

belief that providers will be more 

willing to invest in health IT if there is 

a way of ensuring that the products 

would perform as advertised. Stories 

abound about providers making large 

investments in EHRs only to discover 

that they do not meet their 

functionality, interoperability security 

and/or reliability needs. Certification 

could respond to investment fears 

generated by stories about failed 

investments. A reduction of such fears 

could further the Department’s goal of 

higher rates of sustained health IT 

adoption and interoperability. 

Finally, the Secretary’s decision to 

recognize these criteria was informed by 

the fact that the criteria have been 

validated through prototype testing. 

Any criteria not fully validated by the 

Pilot Test (fewer than 10% fell in this 

category) were not considered for 

recognition. 

In light of the consensus basis, HHS 

reliance, industry impact and 

demonstrated utility of the CCHIT 

criteria for functionality, 

interoperability, security and reliability, 

the Secretary has recognized these 

criteria. He has delegated authority to 

ONC to coordinate and oversee the 

incorporation of these criteria in 

relevant activities among Federal 

agencies and other partner 

organizations, as appropriate. 

FOR FURTHER INFORMATION CONTACT: John 

W. Loonsk, M.D. at (202) 205–0242. 

Dated: August 1, 2006. 

Karen Bell, 

Acting Deputy National Coordinator for 

Health IT. 

[FR Doc. 06–6690 Filed 8–1–06; 1:25 p.m.] 

BILLING CODE 4150–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Availability: Office of the 

National Coordinator for Health 

Information Technology (ONC) Interim 

Guidance Regarding the Recognition 

of Certification Bodies 

AGENCY: Office of the Secretary, HHS. 

Authority: EO 13335 (‘‘Incentives for the 

Use of Health Information Technology and 

Establishing the Position of the National 

Health Information Technology 

Coordinator’’) and Pub. L. 109–149 

(‘‘Departments of Labor, Health and Human 

Services, and Education, and Related 

Agencies Appropriations Act, 2006). 

SUMMARY: This notice provides the 

public with information about the 

availability of a Certification Guidance 

Document (CGD) at http://www.hhs.gov/ 

healthit. The CGD explains the factors 

that ONC will use to determine whether 

or not to recommend to the Secretary of 

the Department of Health and Human 

Services (the Secretary) that he 

recognize a body for certification. Once 

recognized, that body will have 

Recognized Certification Body (RCB) 

status. The CGD will serve as guide for 

ONC as it evaluates applications for 

RCB status and seeks to provide all of 

the information a body would need to 

apply for and obtain such status. By 

publishing the CGD, HHS will ensure a 

transparent and open process as a basis 

for these recommendations. 

To encourage a more widespread 

adoption of interoperable health 

information technology, the Department 

of Health and Human Services (HHS) 

published two final rules in August 

2006 regarding certain arrangements 

involving the donation of interoperable 

electronic health records (EHR) 

technology to physicians and other 

health care practitioners or entities. The 

first, published by the Centers for 

Medicare & Medicaid Services (CMS), 

promulgated an exception to the 

physician self-referral prohibition. The 

second, published by the Office of 

Inspector General (OIG), established a 

safe harbor under the anti-kickback 

statute. In order for the donation of EHR 

technology to be protected under the 

exception and safe harbor provisions of 

these rules, the technology must be 

interoperable. 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].’’ Both rules become effective 

60 days after publication. 

The Department will utilize notice 

and comment rulemaking to formalize 

and finalize the policies and procedures 

that will govern whether ONC will 

recommend to the Secretary a body for 

RCB status. In the meantime, this 

guidance document identifies the 

factors to be considered by the Secretary 

in granting such recognition. In 

addition, the guidance sets forth an 

interim procedure that certifying bodies 

should follow in obtaining recognition 

by the Secretary. Until such time as the 

Department formalizes the procedure, a 

certifying body will be considered 

‘‘recognized by the Secretary’’ if it has 

become an RCB in accordance with the 

interim guidance. The guidance 

document seeks to reduce uncertainty 

about key aspects of the certification 

body recognition process. 

DATES: Public comment may be 

submitted on or before October 3, 2006. 

Comments may be submitted via e-mail 

to RCB-comments@hhs.gov or in written 

form to the address below. 

ADDRESSES: Steven Posnack, Program 

Analyst, Department of Health and 

Human Services, Office of the National 

Coordinator for Health Information 

Technology, 330 C Street, SW., Switzer 

Building, Room 4090, Washington, DC 

20201. 

Please refer to this guidance 

document when submitting comments. 


gechino on PROD1PC61 with NOTICES