Introduction: The Fragmented AI Regulatory Landscape # The United States has no single AI regulatory agency. Instead, AI oversight is fragmented across dozens of federal agencies, each applying its existing statutory authority to AI systems within its jurisdiction. The Federal Trade Commission addresses AI in consumer protection and competition. The Food and Drug Administration regulates AI medical devices. The Equal Employment Opportunity Commission enforces civil rights laws against discriminatory AI. The Consumer Financial Protection Bureau oversees AI in financial services.
The Doctrine That Once Shielded Medical Manufacturers # For decades, the learned intermediary doctrine provided pharmaceutical and medical device manufacturers with a powerful liability shield. The principle was elegant: manufacturers need not warn patients directly because physicians, as “learned intermediaries”, stand between manufacturer and patient. Warn the doctor adequately, and the duty to warn is satisfied.
Healthcare represents the highest-stakes arena for AI standard of care questions. When diagnostic AI systems, clinical decision support tools, and treatment recommendation algorithms are wrong, patients die. With over 1,250 FDA-authorized AI medical devices and AI-related malpractice claims rising 14% since 2022, understanding the evolving standard of care is critical for patients, providers, and institutions.
Executive Summary # AI medical devices are proliferating faster than regulatory infrastructure can track their failures. With over 1,200 FDA-authorized AI devices and a 14% increase in AI-related malpractice claims since 2022, understanding the liability landscape has never been more critical.