U.S. Healthcare IT Deregulation: Details and Impact of the HTI-5 Proposed Rule
The HTI-5 Proposed Rules- ASTP/ONC's Cleanup and the Hard Work
ASTP/ONC is focusing on the development and cleanup of HTI-5 Proposed Rules, indicating a commitment to FHIR-based standards.
Summary
The ASTP/ONC, under HHS, announced the "HTI-5 Proposed Rule" on January 27, 2026. This rule aims to streamline existing regulations regarding data exchange and use, promoting innovation by offering flexibility to developers and providers.
Key Players
Details
On December 29, 2025, the U.S. Department of Health and Human Services (HHS) ASTP/ONC published two proposed rules, including the "HTI-5 Proposed Rule." These rules aim to streamline existing regulations concerning health data technology and interoperability, providing flexibility to developers and providers. The key changes include removing the exception for a 'third party seeking modification use' from Information Blocking exceptions, revising the condition of the 'manner exception exhausted,' and expanding the definitions of 'Access' and 'Use.' Specifically, it now includes the ability or means necessary to make electronic health information available for exchange or use by automation technologies (e.g., robotic process automation, agentic artificial intelligence). ASTP/ONC aims to support a more automated healthcare ecosystem through these changes, allowing patients to spend less time navigating the system and enabling providers to deliver better care. Stakeholder comments on this proposed rule are due by February 27, 2026. Previously, ASTP/ONC had finalized certain provisions of the HTI-2 Proposed Rule (from 2024), establishing regulatory governance for frameworks like TEFCA and QHIN, while also modifying information blocking exceptions.
Technology Note
FHIR（Fast Healthcare Interoperability Resources）は医療データ交換の国際標準。このエントリの関連技術: FHIR
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