Legislation introduced in the U.S. Senate in November, informally called the “Better FDA Act of 2025,” is perhaps a bit misleading. While it involves the Food and Drug Administration (“FDA”), the full title of S. 3122—introduced on November 6—is actually “The Better Food Disclosure Act of 2025,” designed to amend the federal Food, Drug, and Cosmetic Act (“FDCA”) regarding food substances generally recognized as safe (“GRAS”).
Introduction
Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?
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