FDA and CMS Hold Closed-Door Meetings with Health Tech Companies on Clinical AI Regulation

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) convened a private 'clinical artificial intelligence (AI) demo day' with ten health technology companies. The sessions aimed to provide federal regulators with firsthand experience of AI doctor technology in live clinical workflows before formal rulemaking begins, and to discuss specific regulatory standards and Medicare reimbursement terms for AI-assisted clinical services.