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HHS Proposes HTI-5 Rule to Streamline Certification and Boost AI Interoperability

HHS Proposes HTI-5 Rule to Streamline Certification Program, Further Protect

HHS proposed a new rule to streamline its FHIR certification program.

December 22, 2025HHS

Summary

The U.S. Department of Health and Human Services (HHS) proposed the 'HTI-5' rule via its Assistant Secretary for Technology Policy/ONC. This rule aims to reduce burdens on health IT developers, update information blocking regulations, and establish a foundation for AI-enabled interoperability using FHIR-based APIs.

Key Players

HHSFHIR

Details

The U.S. Department of Health and Human Services (HHS), through the ASTP/ONC, released the HTI-5 Proposed Rule with three core goals. First, it aims to reduce the burden on health IT developers by streamlining the voluntary Health IT Certification Program by removing redundant requirements. Second, it updates information blocking regulations to better promote electronic health information access and exchange. Third, it advances a new foundation of Fast Healthcare Interoperability Resources (FHIR®)-based APIs to promote AI-enabled interoperability solutions. Collectively, these proposals are expected to save $1.53 billion in total, including significant time savings for developers. The rule proposes removing over 50% of the existing Certification Program criteria and revising others to focus on standards-based APIs like FHIR. It also revises information blocking terms based on stakeholder feedback, strengthening HHS's enforcement ability. These changes align with presidential directives aimed at reducing regulatory barriers and enabling AI innovation.

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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