AHA urges FDA to make clinical decision support flexibilities permanent and address AI patient safety risks

The American Hospital Association has urged the U.S. Food and Drug Administration to permanently adopt current flexibilities around clinical decision support software and to clarify its general wellness policy for low‑risk devices in light of rapidly evolving AI tools. The letter specifically calls for updated guidance that accounts for novel AI applications, including generative AI, and their implications for patient safety and potential bias in care delivery.