AHA Recommends FDA Permanently Adopt Clinical Decision Support Flexibilities and Clarify Wellness Policy for AI

The American Hospital Association has urged the U.S. FDA to permanently adopt certain flexibilities for clinical decision support software and to clarify its ‘general wellness’ policy in light of novel AI applications, including generative AI. In its response to the agency’s request for information, AHA emphasizes patient safety, calling for updated guidance that reflects emerging AI‑driven decision support tools in clinical practice.