On September 21, the HHS Office of the National Coordinator for Health IT (ONC) announced plans to reduce regulatory burden for health IT developers navigating ONC’s certification process.
Developers will be able to self-declare to an ONC-Authorized Certification Body (ONC-ACB) conformance with 30 of the 55 health IT certification criteria without needing prior functionality testing by an ONC-Authorized Testing Laboratory (ONC-ATL). The ONC also announced it will exercise “enforcement discretion” to no longer actively require ONC-ACBs to conduct randomized surveillance.
These changes will reportedly reduce the time and cost involved in ONC’s health IT certification program for developers. However, the responsibility for discovering and reporting suspected non-conformities could shift to providers and end users as a result. Hospitals and physicians rely on health IT products certified by ONC-ACBs to participate in federal programs, such as the Medicare/Medicaid EHR Incentive Program and the Quality Payment Program.