Lucas Gallegos (Independent) has posted “AI Accountability & Auditability In Clinical Decision Software Act Of 2025 (AACDSA)” on SSRN. Here is the abstract:
The AI Clinical Safety Act of 2025 establishes the first comprehensive federal framework for transparency, auditing, and accountability in artificial intelligence and machine-learning systems used for clinical decision-making in the United States. The Act mandates public explainability summaries, independent risk-scaled audits, and real-time drift monitoring for high-risk tools. Hospitals and vendors must log and report clinician overrides and adverse events, while vendors meeting rigorous audit and transparency standards are eligible for expedited FDA review and liability protection. The Act includes strong anti-gaming provisions, randomized spot audits, whistle-blower rewards, and a five-year sunset with GAO evaluation. By combining transparency, robust independent oversight, and carefully structured incentives, the AI Clinical Safety Act aims to safeguard patients, prevent bias and drift in clinical AI, and foster responsible innovation. This bill provides a statutory template for building trust and safety as AI systems become foundational in modern medicine.