HHS Finalizes HTI-5 Deregulatory Rule to Encourage Innovation and Reduce Health IT Certification Program Compliance Costs

WASHINGTON—October 26, 2026—The Office of the National Coordinator for Health Information Technology (ONC) at the U.S. Department of Health and Human Services (HHS) today released the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Final Rule. This final rule aligns with President Trump’s Executive Order (EO) 14192, Unleashing Prosperity through Deregulation, and EO 14267, Reducing Anti-Competitive Regulatory Barriers, and is projected to save more than $1.5 billion in regulatory costs.

The HTI-5 Final Rule significantly reduces administrative burdens for health IT developers participating in the ONC Health IT Certification Program (Certification Program). These deregulatory changes free up resources for health IT developers that can now be applied toward enhancing user experiences for patients and clinicians.

“American doctors and patients need better technology, not more Washington paperwork,” said HHS Secretary Robert F. Kennedy, Jr. “The Trump Administration is eliminating unnecessary regulations that cost more than $1.5 billion and hold back innovation. We are freeing America’s health technology innovators to build better tools, lower costs, and help doctors spend more time caring for patients.”

As outlined in the 2026 Unified Agenda of Federal Regulatory and Deregulatory Actions, ONC intends to continue to address chronic disease, increase market competition, and lower healthcare costs by improving the access, exchange, and use of electronic health information (EHI). As such, the agency plans to put forth proposals in the future to advance interoperability and EHI sharing through standards adoption; additional updates to the Certification Program to support expanded uses of application programming interfaces (APIs) and potential successor technologies; and targeted conditions of certification.

“Through HTI-5, we have taken decisive action to significantly lower the administrative compliance burden for developers so that they can spend more of their time developing solutions that improve interoperability, automation, and better healthcare for Americans,” said Tom Keane, M.D., National Coordinator for Health IT.

Comments submitted in response to the HTI-5 Proposed Rule’s information blocking proposals remain under consideration as part of HHS’ ongoing efforts to address and eliminate information blocking.

More information about the final rule can be found at healthit.gov/hti5, on LinkedIn, or by following @ONC_HealthIT on X.