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###### Department of Health and Human Services

# 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                           ( print 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