The Food and Drug Administration has issued new guidelines on how it will regulate mobile health software and products that use artificial intelligence to help doctors decide how to treat patients. The guidelines, contained in a pair of documents released Thursday morning, clarify the agency's intent to focus its oversight powers on AI decision-support products that are meant to guide treatment of serious or critical conditions, but whose rationale cannot be independently evaluated by doctors. Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free! STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.