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?
Blog Editors
Recent Updates
- CMS Attempts to Use Medicare and Medicaid Conditions of Participation to Ban Hospitals from Providing Gender-Affirming Care to Minors
- Eleventh Circuit Hears Arguments in Case Addressing Constitutionality of False Claims Act’s Qui Tam Provisions
- First Circuit Clarifies When Clinical Labs Can Rely on Physician Orders
- Understanding the False Claims Act Statute of Limitations—and the Debate Over the “Last Overt Act” Rule
- Podcast: The Down-Low on Data for Value-Based Enterprises and Their Participating Providers – Diagnosing Health Care