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HTI 5 Proposal Signals Health IT Deregulation and FHIR-first Interoperability

米医療ITの規制緩和とFHIR中心化:HTI-5提案の概要

HTI released a proposal (HTI-5) suggesting the elimination of certain long-standing health IT regulations.

January 12, 2026HTI (Health Technology International)

Summary

The U.S. Department of Health and Human Services (HHS) proposed the new 'Health Data, Technology and Interoperability' rule (HTI-5). This aims to accelerate FHIR-based interoperability and revise information blocking rules by simplifying the Health IT certification program.

Key Players

Reed Smith LLP

Details

The HHS, through ASTP and ONC, has issued the HTI-5 proposed rule. This proposal significantly alters the existing Health IT Certification Program, strongly promoting a shift toward FHIR APIs. The key changes include eliminating long-standing, non-FHIR requirements (e.g., Consolidated CDA creation performance) while streamlining criteria like Decision Support Interventions (DSI), which are adapted for the AI era. Furthermore, many certification standards related to privacy/security and design/performance are proposed for removal. Additionally, the Information Blocking rule is being revised to clarify definitions of 'Access' and 'Use,' addressing misuse in an anti-competitive manner and adapting to the rise of automation and AI use. These changes aim to reduce burdens on developers while promoting competition and 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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