ONC issues final rule for permanent certification program

By Molly Merrill
09:57 AM

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish the permanent certification program for health information technology on Monday.

According to the final rule (75 FR 36158), which will be published in the Federal Register on Jan. 7, the National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record technology, such as complete EHRs and/or EHR modules beginning Jan. 1, 2012.

Features of the permanent certification program include

  • Organizations must first be accredited by an ONC-Approved Accreditor (ONC-AA) in order to become Authorized Certification Bodies (ONC-ACBs) to test and/or certify health information technology.
  • ONC-AA status will be granted to only one accreditation body at a time and will be chosen based on a competitive process.
  • Every three years the ONC-AA will be required to renew their status and at this time the ONC will accept new applications.
  • The ONC expects there will be six ONC-ACBs, which will be required to renew their status every three years.
  • ONC-ACBs are required to conduct post-certification surveillance.
  • ONC-ACBs are permitted to perform "gap certification," providing the option for and performing gap certification of previously certified complete EHRs and or modules.
  • ONC-ACBs are allowed to certify other types of HIT in the event that applicable certification criteria are adopted.
  • ONC-ACB are required to accept requests for a newer version of a previously certified complete EHR/and or module to inherit the certified status of the previously certified complete EHR/and or module without requiring the newer version to be recertified.

As proposed, ONC will request that the National Institute of Standards and Technology (NIST) through its National Voluntary Laboratory Accreditation Program (NVLAP) develop a laboratory accreditation program for organizations to be accredited to test health information technology for purposes of the permanent certification program.  Based on NIST's technical expertise and the strong relationship formed between ONC and NIST during the successful implementation of the temporary certification program, the use of NVLAP is expected to enhance testing under the permanent certification program and its objectivity overall.    

"This final rule completes the two-phased approach ONC began with the proposed rule issued in Spring 2010 and includes several important improvements to our certification processes," said David Blumenthal, MD, national coordinator for health information technology. "Our goal is to make the transition to the permanent certification program as seamless as possible."

The temporary certification program, established through a final rule published on June 24, 2010, will continue to be in effect until it sunsets on December 31, 2011, or at a later date when the processes necessary for the permanent certification program to operate are completed. ONC expects to stand-up the programmatic activities necessary to implement the permanent certification program throughout 2011.

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act, as added by the Health Information Technology for Economic and Clinical Health Act.

Read the final rule.

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