Issued2025-07-01

Artificial Intelligence in Healthcare Safety Program

Final RuleSector

Summary

Establishes an AI in Healthcare Safety Program within the Patient Safety Organization framework to identify harms and near‑misses from AI used in care. Provides resources and a pathway for learning from incidents, informed by EO 14110 and PSO confidentiality protections.

Healthcare Implications

Hospitals and PSOs gain a structured channel to report and analyze AI‑related safety events. Risk and quality teams should integrate AI incident capture, root‑cause analysis, and feedback loops into PSO workflows.

Impact Level

Medium

Keywords

Safety & Risk; Transparency & Governance

Stakeholders

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