Tag: Sara Gerke

In a new co-authored article for Nature Reviews Gastroenterology & Hepatology, Professor Sara Gerke explores the risks of “deskilling” for physicians as the use of AI proliferates in the practice of medicine. Gerke and her co-authors also explore whether such systems violate the European Union Artificial Intelligence Act, the world’s first comprehensive regulatory framework on artificial intelligence.

Read the full article at nature.com.

A first-of-its-kind pilot program in Utah developed by a health-technology startup company uses artificial intelligence to automatically renew certain prescriptions for patients with chronic conditions such as hypertension and diabetes. But according to a new paper co-written by a University of Illinois Urbana-Champaign expert in legal issues surrounding cutting-edge medical technology, autonomous AI-based drug prescribing raises important clinical and legal issues.

With AI rapidly being deployed in health care, a “move fast and break things” mentality has permeated the industry, raising complex questions about the role of the U.S. Food and Drug Administration in regulating these technologies, says Sara Gerke, the Richard W. & Marie L. Corman Scholar at the College of Law.

“The big issue here is the relationship between state and federal law, which we’re seeing in Utah, where the state has become a testing ground for so-called AI sandboxes that companies can use to experiment,” said Gerke, also a professor at the European Union Center at Illinois. “The idea behind it is to test these AI medical tools before they are completely developed. But even that is legally questionable. The existence of mitigation agreements and waivers under state law doesn’t automatically render the use of unproven medical technology lawful at the federal level.”

Read more at news.illinois.edu.

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.”

Read the full article at nejm.org.

Replacing animal testing for drug trials is promising, but Professor Sara Gerke and her co-authors on a new paper on the subject believe caution is warranted before adopting change. Gerke recently spoke to the Illinois News Bureau about the paper.

“The primary goal of the FDA is to make animal testing the exception in 3-5 years, and a secondary goal is to get drugs to the market faster by reducing research and development costs,” she said. “Those are all worthy and ambitious goals, but it’s hard not to worry about the attendant risks in doing so. We really need to start thinking about how we ought to validate these new approach methodologies so that they’re at least as effective as animal testing.”

Read the full interview at news.illinois.edu.

As artificial intelligence technology becomes more commonplace, questions about its ethical use are of more salience. In the AMA Journal of Ethics, Professor Sara Gerke examines one area of interest in this field: how ambient listening and transcription technology influences medical doctors’ documentation practices and clinical encounters. In her article, Gerke and her co-author seek to answer questions and provide best-practice recommendations for informed consent processes and patient-clinician relationships.

Read the full article online.

In partnership with the Cancer Center at Illinois, the University of Illinois College of Law hosted the AI in Cancer Surgery and Care Conference on September 4th and 5th, 2025.

Organized by Sara Gerke, Associate Professor of Law & Richard W. & Marie L. Corman Scholar at the University of Illinois, the conference brought together a diverse group of experts to explore the transformative impact of AI on cancer diagnosis, treatment, and surgery. Keynote addresses were delivered by Dr. Ronan Cahill (University College Dublin) and Dr. Ravi Parikh (Emory University), and panel discussions featured 17 additional speakers from within academia and the medical field. The conference facilitated dialogue across disciplines and addressed not only medical and technical breakthroughs, but also the ethical and legal implications of these innovations. 

The regulatory framework for artificial intelligence-based medical devices needs to be improved to ensure transparency and protect patients’ health, says Sara Gerke, the Richard W. & Marie L. Corman Scholar at the University of Illinois Urbana-Champaign and expert in the ethical and legal challenges of artificial intelligence for health care. Gerke argues that the Food and Drug Administration should prioritize the development of labeling standards for AI-powered medical devices in much the same way that there are nutrition facts labels on packaged food. 

Gerke spoke to the Illinois News Bureau about her new paper, recently published in the Emory Law Journal, “A comprehensive labeling framework for AI/ML-based medical devices: From AI Facts labels to a front-of-package AI labeling system — Lessons learned from food labeling.”

Read the full interview.