College of Law

About

Sara Gerke joined the University of Illinois College of Law faculty in July 2024 as an Associate Professor of Law and Richard W. & Marie L. Corman Scholar. Her research focuses on the ethical and legal challenges of artificial intelligence and big data for health care and health law in the United States and Europe. She also researches comparative law and ethics of other issues at the cutting edge of medical developments, such as the clinical translation of stem cell research, biological products, such as somatic cells, tissues, and gene therapy, reproductive medicine, such as mitochondrial replacement techniques, and digital health more generally.

Professor Gerke has over 60 publications in health law and bioethics, especially AI and digital health. Her work has appeared in leading law, medical, scientific, and bioethics journals, such as The George Washington Law Review, Yale Journal of Health Policy, Law, and Ethics, JAMA, Science, Nature Medicine, npj Digital Medicine, Nature Machine Intelligence, Nature Biotechnology, The Lancet Digital Health, Journal of Law and the Biosciences, Journal of Law, Medicine & Ethics, Hastings Center Report, and The American Journal of Bioethics, as well as books published by Cambridge University Press, Elsevier, and Springer. She is also the first editor of a stakeholder book on the clinical application of human induced pluripotent stem cells, which was published by Springer in 2020.

Professor Gerke is leading several research projects. She is the head of the University of Illinois Urbana-Champaign (Illinois) study of the legal and ethical implications raised by AI-assisted surgery in the interdisciplinary project CLASSICA (Validating AI in Classifying Cancer in Real-Time Surgery). This project is funded by the European Union through the Horizon Europe funding program with a total of €6 million for four years with 11 partners from nine countries. She also spearheads the Illinois study on addressing ethical and legal concerns raised by AI in colonoscopy in the interdisciplinary project OperA (Optimizing Colorectal Cancer Prevention Through Personalized Treatment With Artificial Intelligence). This five-year project consists of 17 partners from 13 countries and received a total of €6 million in funding (i.e., €4.7 million from Horizon Europe and the remainder from a U.K. funding body).

Professor Gerke is also co-leading the project BLAST (Bioethical, Legal, and Anthropological Study of Technologies), supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institutes of Health Office of the Director (NIH OD). This project focuses on the ethical, legal, and social issues of three new technologies: robotics, bionics, and bioprinting. She is also a Research Fellow under the Novo Nordisk Foundation Grant awarded to the International Collaborative Bioscience Innovation & Law Programme (Inter-CeBIL programme) at the Faculty of Law, University of Copenhagen.

Beyond her scholarship, Professor Gerke teaches Torts, Health Law, and Food and Drug Law. With her expertise in the ethics and law of AI, big data, and digital health, she has also been frequently invited as a guest lecturer at other schools, such as Harvard Medical School, Harvard T.H. Chan School of Public Health, Massachusetts Institute of Technology, and McGill University, Faculty of Medicine and Health Sciences.

Professor Gerke’s work has been recognized by the scientific, ethical, medical, and legal communities. For example, the American Society for Law, Medicine & Ethics and the Saint Louis University School of Law Center for Health Law Studies named her a 2021 Health Law Scholar. Professor Gerke is a member of several working groups and committees, including an editorial board member of npj Digital Medicine, a member of the American Telemedicine Association (ATA) Data Privacy Workgroup, a member of the Advisory Group — Academic — of the American Board of AI in Medicine (ABAIM), and a member of the Ethical, Legal, and Social Issues (ELSI) Group of DARPA’s ADvanced Acclimation and Protection Tool for Environmental Readiness (ADAPTER) program. Professor Gerke has also presented her work at national and international legal, medical, bioethics, industry, and stakeholder conferences and meetings organized, for example, by the U.S. Department of Health and Human Services, National Academy of Medicine Leadership Consortium, The President’s Cancer Panel, Harvard Law School, Harvard Business School, Stanford Law School, Boston Bar Association, University of Copenhagen, University of Cambridge, University College London, and the University of Oxford.

Before joining Illinois, Professor Gerke was an Assistant Professor of Law at Penn State Dickinson Law and was promoted early to Associate Professor of Law in 2024. Previously, she served as a Research Fellow in Medicine, Artificial Intelligence, and Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, where she oversaw the day-to-day work of the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), including conducting law, policy, and ethics research; drafting reports and recommendations; and coordinating the Center’s efforts with collaborators at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen as well as other partners. Before that, Professor Gerke was the General Manager of the Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim (IMGB).

Education

Dipl.-Jur. Univ., University of Augsburg
M.A. in Medical Ethics and Law, King’s College London

Areas of Expertise

Health Law
Food and Drug Law
Privacy Law
Law and Medicine
Law and Technology
Torts
Comparative Law

Selected Publications

Sara Gerke, Labeling of Direct-to-Consumer Medical Artificial Intelligence Applications for “Self-Diagnosis,” in Digital Health Care outside of Traditional Clinical Settings, 139 (I. Glenn Cohen et al. eds., Cambridge University Press 2024).

Sara Gerke & Delaram Rezaeikhonakdar, Privacy Shield 2.0 – A New Trans-Atlantic Data Privacy Framework Between the European Union and the United States, 45 Cardozo Law Review 2 (2023, published February 2024).

Mindy Duffourc & Sara Gerke, Decoding U.S. Tort Liability in Healthcare’s Black-Box AI Era: Lessons from the European Union, 27 Stanford Technology Law Review 1 (2024).

Sara Gerke, “Nutrition Facts Labels” for Artificial Intelligence/Machine Learning-Based Medical Devices—The Urgent Need for Labeling Standards, 91 The George Washington Law Review 79 (2023).

Sara Gerke, Health AI for Good Rather than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices, 20 Yale Journal of Health Policy, Law, and Ethics 433 (2021, published April 2022).

Sara Gerke, Timo Minssen & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare, in Artificial Intelligence in Healthcare 295 (Adam Bohr & Kaveh Memarzadeh eds., Elsevier 2020).

Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19, 26 Nature Medicine 1176 (2020).

Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device, 3 npj Digital Medicine Article number: 53 (2020).

W. Nicholson Price II, Sara Gerke & I. Glenn Cohen, Potential Liability for Physicians Using Artificial Intelligence 322 JAMA 1765 (2019).

Courses

Health Law
Food and Drug Law
Torts

Gerke publishes co-authored article in New England Journal of Medicine
Illinois LawCast: Get to know Bill Watson and Sara Gerke
SSRN features Q&A with Gerke
Gerke brings CLASSICA research to Illinois Law
Illinois Law welcomes five new faculty hires