[Federal Register Volume 71, Number 150 (Friday, August 4, 2006)]
[Notices]
[Pages 44296-44297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6689]


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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 [email protected] 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.

[[Page 44297]]


FOR FURTHER INFORMATION CONTACT: Steven Posnack at 202-690-7151.

    Dated: July 31, 2006.
Karen Bell,
Acting Deputy National Coordinator for Health IT.
[FR Doc. 06-6689 Filed 8-1-06; 1:25 pm]
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