Summary
Final rule updating the ONC Health IT Certification Program, including first-of-its-kind transparency requirements for artificial intelligence and other predictive decision-support interventions that are part of certified health IT. The rule adopts the Decision Support Interventions certification criterion, expands source-attribute information for predictive tools, requires developer risk-management practices for certain predictive DSIs, adopts USCDI v3, updates information-blocking provisions, and creates the Insights Condition and Maintenance of Certification.
Healthcare Implications
Creates concrete transparency and governance requirements for predictive and AI-enabled decision-support tools embedded in certified EHRs and health IT. Certified health IT developers must support standardized information that helps hospitals and clinicians understand a tool’s intended use, development, training data, performance, fairness, limitations, and risk-management practices, making this one of the most operationally significant federal health-AI transparency rules.