Enhanced Oversight and Accountability Final Rule

This final rule finalizes modifications and new requirements under the ONC Health IT Certification Program (Certification Program), including provisions related to the ONC’s role in the Certification Program. The final rule creates a regulatory framework for ONC’s Direct Review of health IT modules certified under the Certification Program, including, when necessary, requiring the correction of non-conformities found in Certified Health IT and suspending and terminating certifications issued to Certified Health IT Modules. The final rule also sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Certification Program. In addition, it includes provisions for expanded public availability of Certified Health IT surveillance results.