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3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act

Among other responsibilities, section 3001(c)(5) of the PHSA expressly requires the National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, to ‘‘keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted’’ by the Secretary under section 3004.

HHS’s recognition of certain bodies to conduct HIT certification is not new as a result of the HITECH Act.

In August 2006, HHS published two final rules in which CMS and the Office of Inspector General (OIG) promulgated an exception to the physician self-referral prohibition and a safe harbor under the antikickback statute, respectively, for certain arrangements involving the donation of interoperable EHR software to physicians and other health care practitioners or entities (71 FR 45140 and 71 FR 45110, respectively).

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].’’

ONC published separately a Certification Guidance Document (CGD) (71 FR 44296) to explain the factors ONC would use to determine whether or not to recommend to the Secretary a body for recognized certification body status.

The CGD serves as a guide for ONC to evaluate applications for recognized certification body status and provides the information a body would need to apply for and obtain such status.

In section VI of the CGD, ONC notified the public and potential applicants that the recognition process would be formalized through notice and comment rulemaking.

After reviewing the new responsibilities assumed under the HITECH Act and the additional purpose to which the certification of the HIT is now tied (qualifying for incentive payments) in combination with ONC’s current responsibilities under the CGD, we have decided to propose in a separate rulemaking, processes to replace the CGD and establish HIT certification programs as specified by section 3001(c)(5) of the PHSA.

We have decided to proceed with a separate notice and comment rulemaking (which we anticipate publishing shortly after this interim final rule) to establish the policies for the certification of HIT and the process a certification body will need to follow to become an authorized certification body, as determined by the National Coordinator.