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#51 Question [3-17-051-1] Does the ONC Health IT Certification Program (Program) account for instances in which a voluntary consensus standards organization (or steward) issues a correction to a standard or implementation specification after it has been adopted by ONC in a final rule? If so, how?

Guidance for instances in which a voluntary consensus standards organization (or steward) issues a correction to a standard or implementation specification after it has been adopted by ONC

Final

Issued by: Office of the National Coordinator (ONC) of Health Information Technology

#51 Question [3-17-051-1]

Does the ONC Health IT Certification Program (Program) account for instances in which a voluntary consensus standards organization (or steward) issues a correction to a standard or implementation specification after it has been adopted by ONC in a final rule? If so, how?

Yes. In the event that the adopted version of the standard or implementation specification is corrected by a voluntary consensus standards organization (or steward) after it has been adopted by ONC in a final rule, ONC follows a specific approach to determine whether, even if not yet formally adopted by the Secretary, the correction(s) should be incorporated into the testing, certification, and surveillance of health information technology (health IT) to the adopted standard or implementation specification. 

In general, we review corrections to the length, data type, data type descriptions, usage, cardinality and/or value sets for various message elements, as well as corrections to conformance statements where they were mistakenly omitted or not clearly specified by the author of the standard or implementation specification. Each of these examples of corrections, if not implemented by the health IT industry, could lead to interoperability errors as well as the inconsistent implementation of the standard or implementation specification, which may impede electronic health information exchange.  

If ONC determines that a correction(s) creates the concern described above, we will update the appropriate Certification Companion Guide(s) (CCG) to incorporate the correction and provide an interpretative explanation. These CCG notations will include a 90-day delayed effective date for the use of the correction(s) in testing and certification. We expect already certified health IT to include any such identified correction(s) without the need for further testing and certification under the Program. For the purposes of surveillance, there will be an 18-month delayed effective date from the CCG notations before a finding of an identified correction’s absence during surveillance would constitute a non-conformity under the Program.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.