FDA and CMS work to prevent regulatory clash as states move to test clinical AI

Officials at the FDA and CMS are working behind the scenes to avoid a regulatory clash as more states plan to test artificial intelligence tools that perform clinical tasks.

The tension arises from overlapping authority: states license the practice of medicine while the FDA regulates medical devices, including AI that can write prescriptions or make diagnoses without direct human supervision.

The current administration has tried to reduce the regulatory burden on AI developers and create new payment pathways, but unresolved jurisdictional questions could slow broader adoption of health-care AI.