Opportunity
Federal Register #2026-21943
HHS and ONC revise health IT certification regulations
Buyer
Health and Human Services Department
Posted
October 28, 2026
Identifier
2026-21943
HHS and ONC finalized changes to federal health IT certification regulations, rather than announcing a purchase opportunity. - Government entities: U.S. Department of Health and Human Services (HHS), through the Office of the Secretary and the Office of the National Coordinator for Health Information Technology (ONC). - Scope: Amends regulations in 45 CFR parts 170 and 172, including selected health IT certification criteria, standards-related provisions, definitions, and certification program requirements. - Notable changes: Revises developer conditions and maintenance-of-certification requirements, including real-world testing and Insights requirements; removes references to ASTP from part 172. - Purpose: Reduce burdens and costs, give developers and providers more flexibility, and support innovation and interoperability. - Procurement items: No products, services, part numbers, quantities, OEMs, or commercial vendors are identified.
Description
This final rule makes deregulatory changes to HHS regulations governing health information technology standards, implementation specifications, certification criteria, and certification programs. It removes or revises certain certification criteria and regulatory provisions to reduce burden, provide flexibility to developers and providers, and support innovation. The rule also makes changes to conditions and maintenance of certification requirements for health IT developers and removes references to ASTP in 45 CFR part 172. It is effective December 28, 2026, except for amendatory instructions 7, 10, and 12, which are effective January 1, 2027.