Speaker Biographies
AI/ML in Healthcare
Alisa Chestler serves as the chair of the Data Protection, Privacy and Cybersecurity Team at Baker Donelson. She concentrates her practice in privacy, security, and information management issues, including compliance, contract negotiation, and corporate transactions matters. She joined Baker Donelson after a distinguished career as in-house counsel and privacy officer to several large public and private companies, including several managed care organizations and health care companies. She holds a B.A. from Ithaca College and a J.D. from Hofstra University School of Law, and is admitted to the Bar in Connecticut, D.C., and Tennessee. Ms. Chestler is a Certified Information Privacy Professional: United States (CIPP/US) and has also attained certification as a Qualified Technology Expert (QTE).
Barbara J. Evans is Professor of Law and Stephen C. O’Connell Chair at the University of Florida Levin College of Law and holds a joint appointment as Professor of Engineering and Glenn and Deborah Renwick Faculty Fellow in AI and Ethics at UF’s Herbert Wertheim College of Engineering. Her work focuses on data privacy and the regulation of AI/ML medical software, genomic technologies, and diagnostic testing. Currently she is part of the ethics and legal studies team for the NIH Bridge to Artificial Intelligence (Bridge2AI) Patient-Focused CHoRUS for Equitable AI project to develop a national data infrastructure for AI in critical care. Before coming to University of Florida, she worked as an engineer in the energy industry, as an infrastructure economist at the World Bank, and was a Moscow-based partner in the international regulatory practice of a large New York law firm. She held previous academic positions at the Indiana University Center for Bioethics and at the University of Houston, where she was Co-director of their Health Law & Policy Institute and Director of their Center for Biotechnology & Law.
Sara Gerke is an Associate Professor of Law and Richard W. & Marie L. Corman Scholar at the University of Illinois College of Law. 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 and is leading several funded research projects, including CLASSICA (Validating AI in Classifying Cancer in Real-Time Surgery) and OperaA (Optimizing Colorectal Cancer Prevention Through Personalized Treatment With Artificial Intelligence). She holds a Diplom-Jurist from the University of Augsburg and a Master’s in Medical Ethics and Law from King’s College London.
Carmel Shachar, JD, MPH, is Assistant Clinical Professor of Law and Faculty Director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation at Harvard Law School (CHLPI). Ms. Shachar focuses her scholarship on law and health policy, in particular the regulation of access to care for vulnerable individuals, the use of telehealth and digital health products, and the application of public health ethics to real world questions.
Her work, featured in top health and law journals, has reached mainstream media, and she has co-edited multiple books and authored Supreme Court amicus briefs on health care and access to care issues. Previously, Ms. Shachar was the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School Ms. Shachar clerked for Hon. Jacques L. Wiener of the Fifth Circuit Court of Appeals. Ms. Shachar graduated cum laude from Harvard Law School and the Harvard T. H. Chan School of Public Health. She studied Bioethics and Religion at Wellesley College.
Emerging Healthcare Technologies
Sarah Thompson Shick, Counsel at Reed Smith LLP, advises medical products companies developing and manufacturing pharmaceuticals, biologics, and medical devices on issues where FDA regulatory and compliance matters intersect with strategic business decision-making. She specifically focuses on providing FDA regulatory and compliance counsel to medical products clients on a variety of matters, including Good Clinical Practice and clinical trials, pharmacovigilance, medical communications and health care economic information, Good Manufacturing Practice (drugs and medical devices), advertising and promotion, patient support programs, and ClinicalTrials.gov registration and reporting. She has also written and spoken extensively on clinical trial modernization and diversity, in addition to the implications of the recent Food and Drug Omnibus Reform Act (FDORA) and current draft FDA guidance. Ms. Shick previously served as in-house counsel for a publicly-traded biopharmaceutical company and also gained hands-on experience working in the legal department for a large hospital system in Texas.
David A. Simon is an associate professor of law and an expert on intellectual property, healthcare law, data and liability. Professor Simon’s research focuses on innovation in healthcare, with an emphasis on prescription drugs and devices. His current projects include developing a new theory of federal preemption as to claims against prescription drug and device manufacturers that promote off-label uses, designing systems to support research on ultra-rare diseases and conditions, and examining philosophical problems in intellectual property. Professor Simon is also a member of the research team at CLASSICA, a major research project on AI-assisted cancer surgery funded by the European Union. Mr. Simon holds degrees from Harvard (LLM), the University of Cambridge (PhD, Trinity College Member), Chicago-Kent College of Law (JD, order of the coif), and the University of Michigan (BA, high honors).
Robert J. Webster III is the Richard A. Schroeder Professor of Mechanical Engineering, and Associate Provost for Graduate Education at Vanderbilt University. His research is in Surgical robotics, and he leads an active research lab that has spun out two startup companies, Virtuoso Surgical, Inc. and EndoTheia, Inc.; he serves as President of both. Dr. Webster also directs a $12M NIH entrepreneurship center grant spanning four states and directs the $12M ARPA-H ALISS project in which he is applying artificial intelligence and machine learning techniques to automate minimally invasive surgical procedures. Dr. Webster holds a Ph.D. and M.S. in Mechanical Engineering from Johns Hopkins University, as well as a B.S. in Electrical Engineering from Clemson University.
Protecting Health Data
Brad Malin, PhD is the Accenture Professor of Biomedical Informatics, Biostatistics, and Computer Science, as well as Vice Chair for Research Affairs in the Department of Biomedical Informatics, at Vanderbilt University Medical Center. His research is on the development of technologies to enable artificial intelligence and machine learning (AI/ML) in the context of organizational, political, and health information architectures. He co-directs the AI Discovery and Vigilance to Accelerate Innovation and Clinical Excellence (Advance) Center, and the Center of Genetic Privacy and Identity in Community Settings (GetPreCise). Dr. Malin is an elected fellow of several national and international health sciences institutions. Dr. Malin completed his education at Carnegie Mellon University, where he received a bachelor’s in biological sciences, a master’s in machine learning, a master’s in public policy and management, and a doctorate in computer science (with a focus on databases and software systems).
Deborah Farringer is the Associate Dean for Academic Affairs, an Associate Professor of Law, and Director of Health Law Studies at Belmont University College of Law where she teaches a variety of courses, including Health Law, Health Care Fraud and Abuse, Health Care Business and Finance, and Business Associations. Deborah focuses her scholarship on health law and policy, primarily related to health care compliance, including health data technology, fraud, abuse, and privacy issues. Prior to joining the faculty at Belmont, Deborah was a practicing health care attorney focused primarily on transactional matters, including analysis of contracts for compliance with applicable healthcare laws such as the Stark Law, Antikickback Statute, Civil Monetary Penalties Law, and the False Claims Act, physician practice acquisitions, joint ventures, general corporate governance and corporate maintenance issues, hospital operations, and real estate leasing and purchasing issues. Deborah received her B.A. from University of San Diego where she graduated summa cum laude, and her J.D. from Vanderbilt University Law School, where she was elected a member of the Order of the Coif.
Peter Swire is Professor of Law and Ethics at the Georgia Tech Scheller College of Business, and holds the J.Z. Liang Chair in the Georgia Tech School of Cybersecurity & Privacy. He is Senior Counsel with Alston & Bird, LLP, a Senior Fellow with the Future of Privacy Forum, and has been a member of the National Academies’ Forum on Cyber-Resiliency. Under President Clinton, Swire was the Chief Counselor for Privacy, in the U.S. Office of Management and Budget. He was the first person to have U.S. government-wide responsibility for privacy policy. In that role, his activities included being White House coordinator for the HIPAA medical privacy rule, chairing a White House task force on how to update wiretap laws for the Internet age, and helping negotiate the U.S.-E.U. Safe Harbor agreement for trans-border data flows. Under President Obama, he served as Special Assistant to the President for Economic Policy. Swire is author of seven books and numerous scholarly papers. He has testified often before the Congress, and been quoted regularly in the press. Swire graduated from Princeton University, summa cum laude, and the Yale Law School, where he was an editor of the Yale Law Journal.
Roy Wyman is a Member at Bass Berry & Sims PLLC. Mr. Wyman has represented a variety of commercial entities on complex data privacy and security matters and related regulatory concerns. He counsels in-house legal departments, c-suites, boards of directors and IT teams as they navigate data privacy and cybersecurity issues arising under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), General Data Protection Regulation (EU GDPR), Telephone Consumer Protection Act (TCPA), CAN-SPAM Act, state privacy laws like California Privacy Rights Act (CPRA) and other related statutes. Prior to joining Bass, Berry & Sims, Roy chaired the Privacy & Security Industry Group at Nelson Mullins LLP. He also previously served as the Chief Privacy Officer and Associate General Counsel of Regulatory for TeamHealth, Inc., one of the nation’s largest physician staffing companies. He also served as senior legal counsel for CVS Caremark Corp, leading in operational and regulatory matters for certain divisions of CVS Health, including as primary counsel for MinuteClinic retail and for CVS’s disease management, medical/pharmacy software and claims management subsidiaries.
Keynote
Michael McAlevey is Executive Vice President, Chief Legal and Administrative Officer for Nashville, Tennessee-based HCA Healthcare where he oversees HCA Healthcare’s Legal, Ethics & Compliance, Development, Marketing & Corporate Affairs, Government Relations and Information Protection & Security. Prior to joining HCA Healthcare in 2022, McAlevey was a corporate Vice President with General Electric Company for 19 years, serving in multiple senior leadership positions. He served as the global General Counsel for GE Aerospace in Cincinnati, OH and GE Healthcare in Chicago, IL, as well as leading the Business Development functions for each of those businesses. He started his GE career in 2003 as GE’s chief corporate, securities and governance counsel in Fairfield, CT. Following law school, McAlevey served as a law clerk to the Honorable Emmett R. Cox, United States 11th Circuit Court of Appeals, headquartered in Atlanta, GA. From 1989 to 1998 he was an associate and then partner with Alston & Bird, LLP, in Atlanta, GA, specializing in corporate and securities law. From 1998 to 2002, McAlevey served as Deputy Director of the United States Securities and Exchange Commission’s Division of Corporation Finance in Washington DC. McAlevey is director of the HCA Foundation and a Fellow of the Nashville Healthcare Council. He is the former Rector of Washington & Lee University and a former adjunct professor of law at the Georgetown University Law Center where he taught M&A and securities regulation. McAlevey graduated magna cum laude from Washington & Lee University and holds a law degree from the University of Virginia School of Law.