JAMA Network January 29, 2024
Artificial intelligence (AI) holds great promise to enhance the quality of health care.1 Despite the aim of health care regulations to ensure high-quality care, there are few regulations governing the use of AI in health care. This dearth will soon change because a White House executive order instructed the Department of Health and Human Services to develop new AI-specific regulatory strategies addressing equity, safety, privacy, and quality for AI in health care before April 27, 2024.2 Although we agree all these regulatory targets are noble and may themselves improve patient outcomes, the executive order did not address the latter. Here, we argue for a regulatory refocus on patient outcomes.
Traditionally, regulators observe health care systems and treat problems as “teachable...