Issued2025-12-29

HTI-5: Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability

Proposed RuleSector

Summary

Proposes revisions to ONC Health IT Certification Program requirements, including requirements concerning predictive decision support interventions and information-blocking rules for automated and autonomous access to electronic health information.

Healthcare Implications

Could alter transparency, risk-management, and information-sharing expectations for AI-enabled clinical decision-support tools certified under the ONC program.

Impact Level

High

Keywords

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

Stakeholders

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