ONC Issues EHR Certification Program Final Rule

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has released a final rule 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.