[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Notices]
[Pages 9339-9340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Availability: Secretarial Acceptance and Planned 
Recognition of Certain Healthcare Information Technology Standards 
Panel (HITSP) Interoperability Specifications 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''), and 
Public Law 109-149 (``Departments of Labor, Health and Human Services, 
and Education, and Related Agencies Appropriations Act, 2006'').
SUMMARY: By publication of this document, we are informing the public 
of the Secretary's acceptance and planned recognition of certain 
Healthcare Information Technology Standards Panel (HITSP) 
Interoperability Specifications for health information technology as 
interoperability standards. The Secretary accepted these standards, 
version 1.2, in December of 2006, and intends to recognize them in the 
version 2.0 form in December of 2007, presuming that changes from 
version 1.2 to version 2.0 are minor and of a technical nature. This 
list of accepted HITSP standards is available at http://www.hitsp.org 
and 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 among healthcare 
software systems, as they will interact in a local, regional, and 
national 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. HITSP is a multi-
stakeholder organization involving more than 265 different healthcare 
industry organizations whose activities on these Interoperability 
Specifications were supported by more than 12,000 volunteer hours of 
effort. On October 31, 2006, HITSP presented three sets of 
``Interoperability Specifications'' to the American Health Information 
Community (AHIC). The Interoperability Specifications were developed to 
advance the national agenda for secure, interoperable health 
information systems.
    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 first three sets of health data and technical standards. 
Following that discussion, the AHIC reached consensus and recommended 
that the Interoperability Specifications be recognized by the 
Secretary.
    We recognize that certain legal obligations may flow from the 
recognition of these Interoperability Specifications. First, pursuant 
to Executive Order 13410 (EO 13410) dated August 22, 2006, recognition 
of Interoperability Specifications 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 
recognized interoperability standards.'' Therefore, Federal agencies 
would be required to properly 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

[[Page 9340]]

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 by which they certify 
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 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, 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 these Interoperability 
Specifications, and intends to recognize them in version 2.0 form in 
December of 2007, presuming that changes from version 1.2 to version 
2.0 are minor and of a technical nature. 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: February 23, 2007.
Robert M. Kolodner,
Interim National Coordinator for Health IT.
[FR Doc. 07-915 Filed 2-28-07; 8:45 am]
BILLING CODE 4150-24-M