FDA and CMS coordinate with states on health AI regulation

Federal regulators at the Food and Drug Administration and the Centers for Medicare & Medicaid Services are initiating a collaborative effort with state governments to streamline the oversight of artificial intelligence in clinical environments. The initiative seeks to address concerns regarding a potential regulatory logjam as the use of AI technologies in healthcare continues to expand.

Over the past six months, at least a dozen states have launched or announced independent pilot programs for AI in clinical settings. These programs often utilize research exemptions or innovation waivers, creating a fragmented landscape of regional standards that officials fear could complicate the adoption of these technologies.

The primary challenge stems from a jurisdictional overlap between state-level oversight, which governs the practice of medicine and clinician licensing, and federal authority, which regulates medical devices. Federal agencies are now working to align these regional testing plans with national healthcare standards to maintain patient safety while preventing unnecessary delays in innovation.

While agencies continue to develop frameworks for these state-run pilots, industry observers are advising vendors participating in state-level sandboxes to prepare for potential FDA oversight. This is particularly relevant for AI systems that operate without direct clinician supervision, as federal officials move to ensure consistent regulatory compliance across the country.