Requires covered entities using AI Clinical Decision Support Systems (AI/CDSS) to adopt policies allowing health professionals to override AI outputs. Prohibits adverse employment actions for overrides. Enforces whistleblower protections. Instructs creation of AI/CDSS committees and educational materials.
Good coverage — Comprehensive governance measures or mitigations with clear procedures relating to the risk subdomain are explicitly described.
Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the risk subdomain are described.
All other risk subdomains had no coverage in this document.
Risk Coverage Summary
The document primarily addresses human-computer interaction risks (5.1, 5.2) with good coverage, focusing on overreliance on AI and loss of human agency in healthcare settings. It also provides minimal to good coverage of discrimination risks (1.1, 1.3), misinformation (3.1), privacy concerns (2.1), and AI system limitations (7.3, 7.4). The focus is on protecting healthcare professional autonomy and judgment against inappropriate AI substitution.
Good coverage — Comprehensive governance measures or mitigations with clear procedures relating to the sector are explicitly described.
Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the sector are described.
All other sectors had no coverage in this document.
Sectors Summary
This Act exclusively governs the Health Care and Social Assistance sector. It applies to healthcare facilities, health plans, and any entity employing healthcare professionals that uses AI Clinical Decision Support Systems (AI/CDSS). The regulation is comprehensive and sector-specific, establishing detailed governance requirements for AI use in healthcare settings.
Hard Law
Legislative Status Summary
This is a binding federal statute from the United States Congress with mandatory obligations, enforcement mechanisms including civil monetary penalties, private rights of action, and specific regulatory authorities designated to the Secretary of Health and Human Services and Secretary of Labor.
Proposer
Target
Enforcer
Monitor
Lifecycle stages covered by the documents, as defined in the OECD Framework for the Classification of AI Systems
AI Lifecycle Summary
The document focuses primarily on the Deploy and Operate and Monitor stages of the AI lifecycle. It establishes governance requirements for deploying AI/CDSS in healthcare settings and mandates ongoing operational monitoring through quarterly committee reviews, feedback mechanisms, and performance oversight. There is minimal coverage of the Build and Use Model stage through training requirements on development processes.
Terms relating to technical scope that are mentioned or implicitly referenced in the document
Technical Scope Summary
The document explicitly defines and covers AI/CDSS (Artificial Intelligence Clinical Decision Support Systems), which are AI systems used in healthcare. It does not distinguish between frontier AI, general purpose AI, task-specific AI, foundation models, or generative AI. No compute thresholds or open-weight models are mentioned. The focus is on clinical decision support systems specifically.
Document data from AGORA, CSET Emerging Technology Observatory.