Gerke, the Richard W. and Marie L. Corman Scholar at the College of Law, is an expert in health law and bioethics with a particular focus on artificial intelligence and digital health. She also holds an affiliation as a professor in the European Union Center at Illinois.

Gerke’s research examines the ethical and legal challenges of AI and big data in healthcare as well as health law in the U.S. and Europe. She has led or contributed to numerous interdisciplinary projects that draw on her expertise in these fields, especially in emerging medical technologies such as artificial intelligence, robotics, bionics and stem cell research. Currently, Gerke is leading two major Illinois studies funded by the European Union through the Horizon Europe funding program: the legal and ethical implications of AI-assisted surgeries and the concerns raised by the use of AI in colonoscopies. With the explosion of interest in subject matters related to her research, Gerke’s work and perspective are in demand. She has more than 100 publications in her portfolio, is a frequent guest lecturer at institutions across the world and served as an external reviewer for the World Health Organization’s guidance on the “Ethics and Governance of Artificial Intelligence for Health.” 

Learn more about the other faculty members selected for this prestigious honor at news.illinois.edu.

Read the full article at nature.com.

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.

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.

“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.

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Read more about the NSF CAREER Club.

Read the full interview with IGPA online.

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. 

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.