AHA Responds to FDA Request for Input on Development of 21st Century Cures Act Section 3060 Report

The American Hospital Association has submitted comments to the FDA urging that recent flexibility on enforcement for some clinical decision support functions be made permanent. The letter supports the agency’s January 2026 guidance, which provides enforcement discretion for CDS tools that output only one clinical recommendation under specified criteria, and calls for a stable regulatory environment for AI-enabled CDS in hospitals.