FDA and CMS Move to Prevent Clash With State AI Sandboxes
TL;DR
- STAT reports FDA and CMS officials are coordinating behind the scenes to avoid a regulatory logjam as more states stand up clinical-AI testing programs.
- The jurisdictional snarl: states license clinicians, FDA regulates devices, and AI that writes prescriptions without a human in the loop invokes both.
- The Trump administration is simultaneously trying to loosen rules on health-AI developers and open new Medicare payment pathways for the products.
Federal officials are working behind the scenes to head off a jurisdictional clash with states over clinical AI, STAT reports.
The problem is that two layers of American medicine both have a claim on AI that acts like a doctor. States regulate the practice of medicine and license clinicians; the FDA regulates medical devices. An AI tool that writes prescriptions without a human in the loop sits inside both frames at once. STAT reports officials fear "confusion over overlapping jurisdictions could stall health AI adoption."
The Trump administration is pulling in two directions on this. It wants to reduce the regulatory burden on health-AI developers and has stood up new Medicare payment pathways for the products, even as its own agencies move to defuse a "regulatory logjam" with state sandbox programs already deploying clinical AI.
This is the latest in a steady run of regulation stories our scanners have logged, including 76 healthcare-AI items in the last 90 days.
Originally reported by statnews.com
Read the original article →Original headline: STAT: FDA and CMS Scramble Behind the Scenes as State Clinical-AI Sandboxes Collide With Federal Rules