American Hospital Association Urges FDA to Make Flexible Clinical AI Enforcement Policy Permanent

The American Hospital Association responded to an FDA request for input on Section 3060 of the 21st Century Cures Act, backing the agency’s January 2026 guidance that allows enforcement discretion for certain clinical decision support software that offers a single recommendation. The AHA called on the FDA to make this flexibility permanent, arguing it will support responsible deployment of AI-enabled tools while maintaining patient safety.