Symposium 2020 will be rescheduled.
The situation involving COVID-19 has affected the travel plans for many who were scheduled to attend “The Law and Policy of Artificial Intelligence in Healthcare” symposium. As a result, the Minnesota Journal of Law, Science & Technology has decided to reschedule the March 27th event to a to-be-determined date next fall. This website will be updated once a date is determined.
The Law and Policy of Artificial Intelligence in Healthcare
The University of Minnesota Law School and the Minnesota Journal of Law, Science & Technology welcomes you to join our upcoming symposium on The Law and Policy of Artificial Intelligence in Healthcare, which will be taking place at the Minnesota Law School on a date to be determined.
The symposium will focus on the current state of artificial intelligence (“AI”) in healthcare and its ensuing implications. Topics will include how AI is revolutionizing health care, reshaping what it means to practice medicine, challenging existing regulatory schemes, and informing norms about patient information, data, and privacy. The symposium will feature panel discussions regarding civil liability, intellectual property, regulatory, and ethical issues surrounding AI in healthcare.
CLE Credits: 6.5 Standard CLE credits.
Registration is free and open to the public.
Speakers and Moderators:*
Professor Bakul Patel, MBA, MS
Bakul Patel, MBA, MS is Center Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software. Mr. Patel is leading the effort for the agency in developing the precertification program in collaboration with all stakeholders. Prior to joining FDA, Mr. Patel held key leadership positions in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations. Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University.
Introduction into AI in Healthcare Speaker: TBD
Medical Device Use of AI in Healthcare:
Dr. Rodolphe Katra, PhD, MBA
Dr. Katra is Director of Research & Development at Medtronic Inc, in the Cardiac Rhythm & Heart Failure Division. With over 20 years of experience in the field, he leads Data Management Solutions and Analytics efforts for diagnostics, patient services and cardiac monitoring. His team leverages AI/ML, DSP, predictive analytics and technology platforms to advance the field of personalized arrhythmia identification, contextual arrhythmia monitoring and patient management for implantable and wearable medical devices. Dr. Katra holds a doctorate in Biomedical Engineering from Case Western Reserve U., and an MBA with emphasis on International Strategic Management, and Medical Industry Leadership from the Carlson School of Management at the U. of Minnesota. Dr. Katra also has 50+ peer-reviewed publications and awarded patents in the areas of cardiac electrophysiology, personalized pathophysiology detection, prediction, monitoring and disease management.
Challenges in Regulating AI in Healthcare Panelists:
Barbara Evans, Ph.D., J.D., LL.M.
Barbara J. Evans is the Mary Ann and Lawrence E. Faust Professor of Law and Director of the Center for Biotechnology & Law at the University of Houston Law Center. She holds a joint appointment as Professor of Electrical and Computer Engineering at the UH Cullen College of Engineering. Her research interests include wireless brain/computer interfaces for prosthetic and rehabilitative applications, data privacy and access issues with large-scale data systems for genomic and pharmacoepidemiological applications, and FDA regulation of clinical decision support software and genomics software, including artificial intelligence/machine-learning algorithms. Before coming to academia, she was a partner in the international regulatory practice of a large New York law firm. She was named a Greenwall Faculty Scholar in Bioethics for 2010-2013 and is an elected member of the American Law Institute. She holds a BS in electrical engineering from the University of Texas at Austin, an MS & PhD from Stanford University, a JD from Yale Law School, an LLM in Health Law from the University of Houston Law Center, and she completed a post-doctoral fellowship in Clinical Ethics at the MD Anderson Cancer Center. She is admitted to the practice of law in New York and Texas.
Nicholson Price is a Professor of Law at the University of Michigan Law School. His work considers how various areas of law shape biomedical innovation. Recent areas of focus include big data and artificial intelligence in medicine, drug and biologics manufacturing, and the grant system as an innovation policy lever. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. He teaches patents, health law, innovation in the life sciences, and science fiction and the law. He recommends reading Bujold, Jemisin, and Older. Nicholson is cofounder of Regulation and Innovation in the Biosciences; co-chair of the Junior IP Scholars Association; co-PI of the Project on Precision Medicine, Artificial Intelligence, and the Law at the Petrie-Flom Center at Harvard Law School; and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.
Professor Ralph F. Hall is a professor of practice at the Law School. He concentrates his teaching, research and writing in the area of FDA regulation and health care. He is also a principal with Leavitt Partners, a health care policy and consulting firm. At Leavitt Partners he works with coalitions and clients focused on improving FDA and health care regulation and advancing value based health care. He also serves as CEO of MR3 Medical LLC, a start-up medical device company. He is a frequent speaker on FDA regulatory issues and compliance matters and has testified a number of times before Congressional committees.
Prior to his association with the University of Minnesota Law School, Professor Hall served in various capacities with Guidant Corporation including Senior Vice President and Deputy General Counsel—Litigation and Compliance and General Counsel of the Cardiac Rhythm Management group. During this time, Professor Hall also served as Special Counsel to the Guidant Board of Directors Compliance Committee and as Counsel to the Guidant Chief Compliance Officer. Prior to joining Guidant, he was with Eli Lilly, including serving as the head of Lilly’s worldwide environmental law group. He has also served in an Of Counsel role with the law firm of Faegre Baker Daniels.
Professor Hall received his B.A. magna cum laude from Indiana University in 1974 and his J.D. cum laude from the University of Michigan where he was a Weymouth Kirkland Scholar. Professor Hall’s interests include FDA regulation, corporate compliance and governance, negotiations and the interface between corporate practice and the academic world.
Intellectual Property’s Vital Role in Healthcare’s AI-driven Future Speaker:
Dr. David Raczkowski is a partner at Kilpatrick Townsend & Stockton LLP, a multi-practice international law firm. Dr. Raczkowski focuses his practice on patent prosecution and counseling. He works with clients to identify inventions from general product specifications and evaluate patentability to determine patent strategy for a single patent application or across a patent family. Prior to joining the legal profession, Dr. Raczkowski conducted research as a postdoctoral fellow in scientific computing and computational physics at Lawrence Berkeley National Laboratory. Dr. Raczkowski obtained his B.S. in mathematics and physics from University of Michigan, his Ph.D. in physics from UC Davis, and J.D. from University of San Francisco School of the Law.
Potential Liability Issues Arising from the use of AI in Healthcare Panelists:
Gary Marchant serves as the Regents’ Professor and Lincoln Professor of Emerging Technologies, Law & Ethics, and Faculty Director of the Center for Law, Science & Innovation, at the Sandra Day O’Connor College of Law, Arizona State University (ASU). He teaches, researches and speaks about the governance of a variety of emerging technologies, including biotechnology, genetics, neuroscience, nanotechnology, artificial intelligence and blockchain. Prior to joining the College faculty in 1999, Professor Marchant was a partner at the Washington, D.C., office of Kirkland & Ellis, where his practice focused on environmental and administrative law. He received his J.D. from Harvard Law School, where he was awarded the Fay Diploma (awarded to top graduating student at Harvard Law School). He also has a Ph.D. in genetics from the University of British Columbia and a Masters of Public Policy from the Kennedy School of Government.
Scott J. Schweikart
Scott J. Schweikart, JD, MBE is a Senior Research Associate at the American Medical Association (AMA) in Chicago, where he works for the AMA’s Council on Ethical and Judicial Affairs (CEJA), the body charged with writing and updating the AMA Code of Medical Ethics. Mr. Schweikart provides research support for CEJA’s work, by contributing detailed research analysis, written policy reports, and analytical memoranda. He also reviews and provides analysis to the AMA’s Litigation Center for any bioethical issues that arise in their amicus briefs. Mr. Schweikart is also the Legal Editor of the AMA Journal of Ethics, where he writes articles related to law and bioethics and where he edits legally oriented journal submissions. Before joining the AMA, Mr. Schweikart worked at Thomson Reuters (Westlaw) where he was an attorney editor and reference attorney. Mr. Schweikart has research interests in health law, health policy, and legal aspects of bioethics. He earned his Master of Bioethics (MBE) from the University of Pennsylvania, his JD from Case Western Reserve University, and his BA from Washington University in St. Louis.
Kate Middleton is an experienced litigator who represents clients nationwide in complex commercial litigation matters. Kate specializes in restrictive covenant and trade secret litigation across a number of industries, including health care, and health care litigation. In her healthcare litigation practice, Kate represents health care providers, device manufacturers, and hospital systems in a variety of areas of litigation, including commercial disputes, restrictive covenant enforcement, product liability, and tort liability.
Ethical Considerations of using AI in Healthcare Panelists:
Cara Tenenbaumis an expert healthcare policy analyst that specializes in women’s health, digital health and personalized medicine. As a Director on the Health Innovation team, Cara In she leads and manages multiple client projects with a focus on improving access to reproductive and sexual health services. She also focuses on treatments and services for mental health and substance use disorders.
Cara most recently served as a Senior Policy Advisor at the Center for Devices and Radiological Health at the Food and Drug Administration (FDA). In this role, she worked with internal and external stakeholders regarding key policy issues. Cara also served in the Office of Legislation and the Office of External Affairs while at the FDA.
Previously, Cara spent seven years in policy and advocacy at what is now the Ovarian Cancer Research Alliance, serving as Vice President for Policy and External Affairs. She has dedicated her career to increase access to healthcare for women, from ovarian cancer to abortion.
Cara received her Juris Doctor (JD) and Masters in Business Administration (MBA) from Case Western Reserve University and her Bachelor’s degree from the University of Maryland.
Dr. Richard Sharp
Dr. Richard Sharp is Professor of Biomedical Ethics and Medicine at Mayo Clinic. He is the Director of the Biomedical Ethics Program at Mayo, including the Center for Individualized Medicine’s bioethics program and theclinical & translational research ethics program. Prior to joining Mayo Clinic in 2013, he was Director of Bioethics Research at Cleveland Clinic and Co-Director of the Center for Genetic Research Ethics and Law at Case Western Reserve University, one of six NIH Centers of Excellence in Ethics Research. Dr. Sharp has published widely on topics in biomedical ethics, including clinical ethics consultation, informed consent, financial conflicts of interest, and ethical tensions in patient advocacy. His current research is examining how patients and healthcare providers view new forms of personalized medicine and clinical interventions enabled by molecular diagnosis. Dr. Sharp frequently advises healthcare organizations on ethical issues and has served on advisory committees for the National Institutes of Health, Institute of Medicine, American College of Medical Genetics, and US Environmental Protection Agency.
Dr. Pilar Ossorio
Pilar N. Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin-Madison (UW) and the Scholar-in-Residence and Program Lead for the Ethics Program at the UW-affiliated, non-profit Morgridge Institute for Research. She is program faculty for the Neuroscience Training Program and the Computation in Biology and Medicine Training Program, and was the Ethics Lead for UW’s first big data center (the Center for Predictive Computational Phenotyping). She received her Ph.D. in Microbiology and Immunology from Stanford University and her law degree from the University of California at Berkeley. Dr. Ossorio has served on numerous national and international policy and ethics advisory committees. Currently, she is a member of the Novel and Exceptional Technology and Research Advisory Committee (NIH); the Ethics, Legal, and Social Implications Panel for the DARPA Measuring Biological Aptitude Program (DARPA); and the External Expert Panel for the Kidney Precision Medicine Project (NIH). She is a member of the Board of Reviewing Editors for the journal Science. The main themes in Dr. Ossorio’s research involve ethics and governance of emerging technologies; ethics and regulation of research with human participants; and the use of racial concepts in biomedical research and health care. Some recent articles include: Do No Harm – A Roadmap for Responsible Machine Learning for Healthcare, Nature Medicine 25:1337 (2019); The Challenge of Regulating Clinical Decision Support Software After 21st Century Cures, Journal of Law, Medicine and Ethics 44: 237 (2018); Fairness in Manufacturing Cellular Therapies, American Journal of Bioethics, 18: 68 (2018).
* Additional panelists booked and to be added upon receipt of photos and bios.