The Office of the National Coordinator of Health IT has issued its first surveillance guidance to assist its ONC-Authorized Certification Bodies (ONC-ACBs), which certify which electronic health record products qualify for participation in the Meaningful Use Incentive program.
The ONC-ACBs are required by the permanent health IT certification program to conduct periodic surveillance of the EHR products they certify. The new guidance, issued July 2, outlines ONC's surveillance requirements, such as annual submission of a surveillance plan and surveillance approach. It flags four surveillance plan elements that ONC considers priorities for the ONC-ABCs to monitor:
- Exchange capabilities
- Safety-related capabilities
- Security capabilities
- Population-management capabilities
In addition, the guidance states that the assessment of EHR developers' complaint processes is a priority of ONC, and that the ONC-ACBs' surveillance plans need to address how they will assess vendors' handling of complaints, especially safety-related ones.
The guidance also "strongly encourages" ONC-ACBs to make their surveillance plans and results publicly available after submitting them to ONC.
The U.S. Department of Health & Human Services has only revoked the certification of two EHRs for failure to meet the standards of the Meaningful Use incentive program since the program's inception. The two products--both developed by EHRMagic, Inc. of Santa Fe Springs, Calif.--failed re-testing, which was conducted by ONC-ACB InfoGard Laboratories, Inc. According to an April 25, 2013, revocation announcement, the products "should not have passed certification."