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HIT Certification: Stark and Anti-Kickback in HIT

To encourage widespread adoption of interoperable health information technology, the Department of Health and Human Services (HHS) published in August 2006 two rules in which the Centers for Medicare & Medicaid Services (CMS) and Office of Inspector General (OIG) promulgated an exception to the physician self-referral prohibition and a safe harbor under the anti-kickback statute, respectively, for certain arrangements involving the donation of interoperable EHR technology to physicians and other health care practitioners or entities.

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].”

Interim Guidance Regarding the Recognition of Certification Bodies Current Recognized Certification Bodies (PDF - 40.1KB)

In August 4, 2006, the Department published two Notices of Availability, identifying the posting and availability of certain criteria it recognizes for the certification of EHR software and a guidance document for entities to apply to be recognized by the Department as a Recognized Certification Body.

Recognized Ambulatory EHR Certification Criteria (PDF - 95.2KB)

Current Recognized Certified Bodies

  • Certified Ambulatory Electronic Health Record Products

    The Certification Commission for Healthcare Information Technology is the recognized certification body for electronic health records and their networks. CCHIT was recognized as a certification body on October 26, 2006 (Press Release). To learn more about CCHIT, the certification process and to obtain a list of currently certified products go to

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Personal Experiences

"We have hospitals in Afghanistan and Iraq, and many of the soldiers would arrive without records in Germany, with no record of the CAT scans or what happened in surgery in Afghanistan or Iraq. The clinicians in Germany would have to re-operate on the patient, would have to redo all their x-ray evaluations, CAT scans, etc...." ~ Colonel John Holcomb

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