The Office of the National Coordinator for Health Information Technology (“ONC”) began the month of March and the HIMSS Annual Conference with the announcement of an unexpected proposed rule, the Enhanced Oversight and Accountability Rule (the “Oversight Rule”). The Oversight Rule would expand ONC’s role in the ONC Health IT Certification Program (“Program”). Specifically, the Oversight Rule provides ONC with express powers to directly review health IT certified under the Program and employ review, suspension, and termination processes to address “non-conformities” found in certified health IT. The ONC is seeking comment on key issues such as the scope of ONC’s proposed direct review authority, its processes for reviewing certified and uncertified health IT capabilities, and the agency’s potential overlap with the authority of other agencies. All public comments will be due to ONC on or before May 1, 2016.
As stated in the ONC’s press release, the Oversight Rule focuses on three areas: Direct Review, Enhanced Oversight, and Greater Transparency and Accountability.