HHS and the Office of the National Coordinator have released a proposed rule that would modify the ONC Health IT Certification Program.
Here are four things to know about the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule.
1. Under the proposed rule, the ONC would be able to directly review health IT products certified under the ONC Health IT Certification Program. The review would extend to include "interaction of certified and uncertified capabilities within the certified health IT and to the interaction of a certified health IT's capabilities with other products." The proposed review would be independent of reviews conducted by ONC Authorized Certification Bodies.
2. The ONC would have the ability to require the correction of program nonconformities and suspend or terminate an EHR or health IT module's certifications.
3. The proposal also addresses the ONC's oversight power. The ONC would be given direct oversight of National Voluntary Laboratory Accreditation Program-accredited testing labs. NVLAP-accredited labs would apply to become ONC-Authorized Testing Labs, giving the ONC the ability to directly oversee testing and certification performance.
4. The final measure in the proposed rule focuses on transparency. The ONC proposes a requirement for ONC-ACBs to make public results of identifiable surveillance results of certified health IT on their website on a quarterly basis.