HTI-5: Advancing Innovation with a Foundation of Compliance

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On December 29, 2025, the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking: HTI-5. This represents a significant regulatory shift in U.S. health IT. The core intent of HTI-5 is to reduce developer burden, update information blocking regulations, and prioritize FHIR as the backbone for future health data exchange. Proposed changes include eliminating over 50% (34 of 60) of ONC’s current certification criteria and reorienting the Certification Program around FHIR-based APIs designed for safe AI-supported workflows. Qualifacts, while supporting the move toward an open, connected environment, emphasizes that compliance is the platform for innovation. The company acknowledges the potential of FHIR-first architecture and AI capabilities but stresses that progress must not trade rigor for speed. Interoperability requires exchanging data that is trustworthy, secure, and high-quality. The article argues that while HTI-5 streamlines requirements, maintaining a strong compliance culture is essential to ensure stability and predictability in the rapidly evolving ecosystem. The company maintains its belief that compliance is not an obstacle but the foundation enabling durable progress, even as the industry moves faster toward FHIR-based APIs and AI integration. This piece serves as an opinion article analyzing the implications of HTI-5, arguing for the continued necessity of high standards of compliance alongside technological advancement.