Health Affairs January 16, 2025
Artificial intelligence (AI) systems are being widely adopted in health care, with applications spanning use in clinical care to administrative applications such as billing and insurance denials. However, concerns have been raised about whether AI systems used in clinical care are effective and safe.
To achieve fair, appropriate, valid, effective, and safe AI, a comprehensive regulatory framework and clear guardrails to guide AI development and application are needed. While certain federal agencies have taken limited action—such as the Food and Drug Administration’s oversight over AI-enabled medical devices, the Assistant Secretary for Technology Policy/Office of National Coordinator for Health Information Technology’s oversight over health information technology, and the Health and Human Services Office for Civil Rights mandate on AI bias for...