Is Utah’s first-in-the-nation pilot program allowing AI to renew prescriptions legal and ethical?

Utah has introduced a first-in-the-nation pilot program that allows AI to independently renew certain prescriptions for patients with chronic conditions. The 12-month initiative, which launched in January 2026, uses an AI system developed by the health tech company Doctronic, and operates under a special state “regulatory sandbox” designed to test emerging technologies. A New England Journal of Medicine (NEJM) article, authored by Sara Gerke, Ravi B. Parikh, and I. Glenn Cohen, raises serious questions about its efficacy and legality.

The program currently applies to nearly 200 commonly used medications, including treatments for conditions such as high blood pressure, diabetes, and depression. State officials say the goal is to improve medication adherence. After an initial review period of 250 cases by a physician, the AI system will begin making prescription renewal decisions without direct human oversight.

While the authors agree that “autonomous prescription renewal may offer benefits in narrowly defined clinical contexts,” they focus on several medical and legal issues raised by the program, including:

  • Risks when the system is used for medications requiring frequent dose adjustments or in patients whose clinical status could change rapidly.
  • Whether Doctronic problematically failed to seek FDA premarket authorization for the AI system as a medical device.
  • Whether AI-based prescribing is an instance of “misbranding” carrying potential civil or criminal penalties, because prescribing must be done by “a practitioner licensed by law to administer such drug.”

The article also discusses the complex relationship between state and federal law at play in such autonomous AI systems. “Such systems hold a lot of potential benefit for patients,” said I. Glenn Cohen, a Professor and Deputy Dean at Harvard Law School and one of the article’s authors, “but especially as the first-in-the-nation, it is important for patients that the developers consider all the legal and ethical issues raised.”

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