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ARTICLE · 31 DECEMBER 2025

HHS Proposes Rule To Deregulate Health IT And Advance AI-Interoperability (HTI-5)

Nelson Mullins Riley & Scarborough LLP
Nelson Mullins Riley & Scarborough LLP
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Nelson Mullins Riley & Scarborough LLP

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The Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC)...

United StatesTechnology

The Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), has released a proposed rule that would significantly roll back federal certification requirements for health IT developers. The proposal—known as HTI-5, the fifth iteration of the Health Data, Technology, and Interoperability rulemaking—marks one of the most consequential shifts in federal health IT policy in years.

ASTP/ONC frames the proposal as a targeted deregulatory effort designed to eliminate duplicative or outdated requirements, reduce compliance costs, and redirect industry focus toward interoperable, AI-enabled health data exchange. The rule explicitly advances President Trump's Executive Orders on Unleashing Prosperity Through Deregulation and Reducing Anti-Competitive Regulatory Barriers.

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