ONC issues EHR certification program final rule

HCPRO Website, January 4, 2011

Permanent program certifying health IT to take effect January 1, 2012

The HHS Office of the National Coordinator for Health Information Technology (ONC) released a final rule January 3 establishing a permanent health information technology (health IT) certification program. The rule describes the permanent certification program for electronic health records (EHR), and how organizations become authorized to test and certify EHR technology. ONC plans to replace the temporary program currently in effect with the permanent version January 1, 2012, though it may delay this date if necessary.
“The permanent certification program provides new features that will enhance the certification of health information technology, including increasing the comprehensiveness, transparency, reliability, and efficiency of the current processes used for the certification of EHR technology,” according to a January 3 press release.

Changes include the following:

  • The National Institute of Standards and Technology (NIST) will accredit organizations to test EHRs and other health IT via its National Voluntary Laboratory Accreditation Program.
  • The national coordinator must approve all EHR technology testing tools and procedures for ONC-Authorized Certification Body (ONC-ACB) certification. ONC will work with NIST to develop the tools and procedures, but others may also submit them for approval.
  • The ONC will approve one certification-body accreditor every three years through a competitive process.
  • All certification bodies—including those authorized under the temporary program—must apply to become ONC-ACBs, and will have to renew their status every three years.
  • Gap certification will be available as an option to have previously certified EHR technology tested and certified on only applicable new or revised certification criteria that may result from future rulemaking.
“Today, it appears that capabilities are evaluated. Actual testing of products to make sure they do what the test script says is needed,” says Margret Amatayakul, MBA, RHIA, CHPS, CPHIT, CPEHR, CPHIE, FHIMSS, president of Margret\A Consulting, LLC in Schaumburg, IL, who hopes the permanent program testing will be more rigorous than that of the temporary program. “However, all this still is in the context of the fact that the meaningful use criteria are the minimum needed for the incentive program. There may well be other product capabilities that a hospital or clinic needs for everyday use.”
The transition will have no affect on previously-issued EHR technology certifications, according to the ONC website.
“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,” David Blumenthal, MD, MPP, national coordinator for health IT said in the press release. “Our goal is to make the transition to the permanent certification program as seamless as possible.”
The HITECH Act requires providers to use certified EHR technology to qualify for payments under the Medicare and Medicaid EHR Incentive Programs.
Editor’s note: Click here to view the HHS press release. Additional information on the certification program is also available in an ONC fact sheet. Information on the EHR incentive program website is available at www.cms.gov/EHRIncentivePrograms. For a list of certified EHR systems or modules on the ONC’s certified health IT product list, visit http://onc-chpl.force.com/ehrcert.


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