HHS Unveils Final Health IT Certification Rules

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The U.S. Department of Health and Human Services has released a final rule to establish a permanent certification program for e-health records and other health IT products.

The new permanent certification program "will eventually replace" the temporary certification program that's been in place since last June, said the Office of National Coordinator for Health IT (ONC) in a statement.

While the new permanent certification program does not impact the criteria and standards used to evaluate and certify e-health record and other health IT products, the new program clarifies the rules for the handful of organizations that provide the testing and certification.

Healthcare providers must meaningfully use "certified" health IT in order to be eligible for Centers of Medicare and Medicaid Services (CMS) financial rewards that are estimated to total more than $20 billion.

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 electronic health record (EHR) technology," said Dr. David Blumenthal, National Coordinator for Health IT, in a statement.

The less detailed temporary certification program unveiled last year aimed to help healthcare providers get a jump start in making EHR purchase and rollout decisions in order to qualify starting in 2011 for financial incentives for the meaningful use of health IT.

Testing and certification under the permanent certification program is expected to begin on Jan. 1, 2012 "or upon a subsequent date when the National Coordinator determines that the permanent certification program is fully constituted," according to the 227-page final rule published Monday in the Federal Register.

To date under the temporary program, there are about a half dozen organizations that have been deemed by ONC as "authorized certification bodies," or ONC-ACBs, to test and/or certify that EHR products, including modules and comprehensive packages, meet interoperability and other standards and requirements to facilitate ONC's meaningful use criteria.

Those organizations authorized under the temporary program will need to reapply for authorization under the permanent certification program.

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The Certification Commission for Health IT, or CCHIT, is among the half-dozen ONC-ACBs that have been testing and certifying EHRs products under the temporary program. CCHIT will seek to be authorized under the permanent program as well, said CCHIT chair Karen Bell.

"The good news is that ONC has given us a year for the transition before the permanent program goes live," she said in an interview with InformationWeek. In the meantime, CCHIT will continue to test and certify products for ONC meaningful use certification.

To date, CCHIT has certified about 131 EHR products under the meaningful use criteria, including 39 packages that are sold for hospital environments and 92 products used for doctor practices or other "eligible providers," she said.

Under the temporary program, ONC granted authorization to organizations officially to test and or certify health IT products. However, under the permanent program, ONC will hand over that role to a yet unnamed "accreditation" organization that will grant authorizations to certification bodies.

Also, ONC said it 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 IT for the permanent certification program.

The rules of the permanent certification program "also open the door" for organizations in the future to be authorized to test and certify other health IT products that aren't currently identified in the ONC's meaningful use programs, such as remote monitoring and other devices, said CCHIT's Bell.

As for CCHIT, Bell expects 2011 to be a busy year, not only as other vendors seek meaningful use certification, but also as many hospitals seek certification for their mix of various vendor systems and/or home-grown EHR systems.

"So far the biggest demand [for testing and certification] has been from vendors, but we expect demand will burst from hospitals," Bell said. CCHIT is piloting a testing and certification program for hospitals.