AHA Responds to FDA Request for Input on Clinical Decision Support and 21st Century Cures Act Reporting

The American Hospital Association submitted comments to the FDA on its upcoming report under Section 3060 of the 21st Century Cures Act, focusing on **non-device clinical decision support (CDS) software**, including AI-based tools. The AHA supports the FDA’s January 2026 guidance that extends enforcement discretion to certain CDS functions producing a single clinically appropriate recommendation, and urges the agency to make this flexibility permanent rather than temporary.