United States Moves to Curb Medical AI Errors

Al-Taj News – The U.S. Food and Drug Administration has opened a public consultation to establish a new framework for regulating medical devices powered by generative artificial intelligence, amid concerns over errors that could affect doctors’ decisions and patient safety.

The agency seeks to establish rules for evaluating these devices before they are placed on the market and monitoring their performance after they enter use, particularly as generative AI may produce different answers or recommendations for the same information and may sometimes provide incorrect results that appear convincing.

The U.S. proposals include classifying devices according to their level of risk, testing their accuracy and safety and their ability to handle different medical conditions, in addition to periodically reassessing them following updates.

The U.S. Food and Drug Administration (FDA) has set October 19, 2026, as the deadline for receiving public comments, in a step that could affect the future of regulating medical artificial intelligence technologies inside and outside the United States.