Issued2025-12-29

HTI-5 Proposed Rule: ONC Deregulatory Actions to Unleash Prosperity

Proposed RuleSector

Summary

Proposes removal or revision of multiple ONC Health IT Certification Program criteria, including predictive decision-support source-attribute and risk-management requirements, and changes to information-blocking rules and interoperability standards. No proposed removal is in effect until a final rule.

Healthcare Implications

If finalized, could change certification and disclosure expectations for predictive decision support and AI-enabled health IT; developers and health systems should continue using current HTI-1 requirements until final action.

Impact Level

High

Keywords

Transparency & Governance; Safety & Risk; Clinical Quality & Efficacy

Stakeholders

Providers & Health Systems; Developers & Vendors; Regulators & Government