Barbara J. Evans
Stephen C. O'Connell Chair
Professor of Law
Professor of Engineering, University of Florida Wertheim College of Engineering
Artificial Intelligence • Biotechnology Law • Data Privacy & Access • Ethics and Regulation of Artificial Intelligence/Machine Learning Medical Software • Food & Drug Law • Health Law • Regulation of Clinical Laboratories • Regulation of Genomic and Gene-editing Technologies •
Barbara J. Evans is a Professor of Law and Stephen C. O’Connell Chair at the University of Florida Levin College of Law and Professor of Engineering at the University of Florida Wertheim College of Engineering. Professor Evans has published widely in law journals and peer-reviewed scientific, medical, and ethics journals, including the New England Journal of Medicine, Science, Nature Medicine, American Journal of Bioethics, Genetics in Medicine, American Journal of Human Genetics, Clinical Pharmacology & Therapeutics, and Journal of the American Medical Informatics Association.
Professor Evans collaborates with multidisciplinary teams of ethicists, scientists, medical researchers, and engineers on a wide variety of research projects sponsored by the National Institutes of Health/National Human Genome Research Institute/National Cancer Institute, the National Science Foundation, and the U.S. Food & Drug Administration. She was named a Greenwall Foundation Faculty Scholar in Bioethics for 2010-2013.
Professor Evans is a Member of the National Academies of Science, Engineering, and Medicine’s Standing Committee on Aerospace Medicine and the Medicine of Extreme Environments and is serving on an Expert Advisory Panel convened by the U.S. Government Accountability Office (GAO) to advise on Artificial Intelligence in Health Care. She has served on National Academies Committees for studies of ethics principles and health standards for long-duration human spaceflights such as trips to Mars; future biotechnology products and the regulatory challenges they present; access to hearing health care for adults; and the public health effectiveness of the FDA’s medical device regulations. She has served on multiple panels and committees to support the U.S. Food & Drug Administration, including ten years’ service on the Privacy Panel for the FDA Sentinel System, a large-scale pharmacoepidemiological data network.
Professor Evans is an elected member of the American Law Institute, a Senior Member of the Institute of Electrical and Electronics Engineers, and is admitted to the practice of law in New York and Texas. Before coming to academia, she worked as an engineer in the energy industry, as an infrastructure economist at the World Bank, and as a Moscow-based partner in the international regulatory practice of a large New York law firm. She taught law and engineering at the University of Houston from 2007-2020 and served as Co-director of their Health Law & Policy Institute and Director of their Center for Biotechnology & Law.
J.D., Yale Law School
LL.M. Health Law, University of Houston
Post-doctoral Fellow, Clinical Ethics, The University of Texas M.D. Anderson Cancer Center
B.S., Electrical Engineering, with Honors, University of Texas at Austin
M.S., Applied Earth Sciences, Stanford University
Ph.D., Earth Sciences, Stanford University
Teaching and Scholarship
Health Law, Food and Drug law, Regulation of Novel Biotechnologies under the U.S. Coordinated Framework, Data Privacy, Regulation of Biomedical Research, Regulation of Genomic and Other Diagnostic Testing, and Torts.
- The central question in Torts is how society should respond to the problem of high dollar typically accidental physical harm, when injury is unfortunate, but unintended. Our course will focus mostly on the problem of unintentional harm, as applied to bodily and emotional harms. Theories covered will include negligence, strict liability, products liability and intentional torts as well as all their affirmative defenses. As there are seldom clear answers with legal questions spanning so many perspectives, and amorphous factual inquiries (including the role of the judge and jury, circumstantial evidence and fundamental problems), Torts trains students to answer timeless amorphous questions, thereby developing keen policy and argumentation skills, applicable to a wide variety of legal areas.
- An accessible survey of regulatory, privacy, and ethical issues with advanced biotechnologies and artificial intelligence medical software, including safety regulation by the FDA.
- This is a critical course for anyone interested in the major federal and state laws governing the modern health care industry, from hospitals to clinical laboratories, biobanks, and academic medical centers.
Law Review Articles
- Barbara J. Evans & Ellen Wright Clayton, Deadly Delay: The FDA’s Role in America’s COVID-Testing Debacle, 130 YALE LAW JOURNAL FORUM 78-100 (2020)
- Barbara J. Evans, The Streetlight Effect: Regulating Genomics Where the Light Is, 48 (Supp. 1) Journal of Law, Medicine, and Ethics 105-118 (2020) (reporting results from the NIH-funded LawSeqSM project)
- Barbara J. Evans, Minding the Gaps in Regulation of Do-it-Yourself Biotechnology, in Symposium: Democratizing Health Care, 21 DePaul Journal of Health Care Law 1 – 18 (2020) [Link]
- Barbara J. Evans, Gail Javitt, Ralph Hall, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan, and Ellen Wright Clayton, for the LawSeq Quality Working Group, How Can Law and Policy Advance Genomic Analysis and Interpretation for Clinical Care?, 48 (Supp.1) Journal of Law, Medicine, and Ethics 44-68 (2020) (reporting results from the NIH-funded LawSeqSM project)
- Mark A. Rothstein, John T. Wilbanks, Laura M. Beskow, Kathleen Brelsford, Kyle B. Brothers, Megan Doerr, Barbara J. Evans, Catherine M. Hammack-Aviran, Michelle L. McGowan, Stacy A. Tovino, Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations, 48 Journal of Law, Medicine, and Ethics196-226 (2020) (reporting results from the NIH-funded project, Addressing ELSI Issues in Unregulated Health Research Using Mobile Devices)
- Barbara J. Evans, The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?, 48(Supp. 1) Journal of Law, Medicine, and Ethics 74-81 (2020) (reporting results from the NIH-funded project, Addressing ELSI Issues in Unregulated Health Research Using Mobile Devices Mobile Health Research)
- Jessica L. Roberts, Alexandra L. Foulkes, Paul S. Appelbaum, Wendy K. Chung, Ellen Wright Clayton, Barbara J. Evans, Gary E. Marchant, Can Clinical Genetics Laboratories be Sued for Medical Malpractice?, 29 Annals of Health Law and Life Sciences 153-172 (2020)
- Barbara J. Evans & Susan M. Wolf, A Faustian Bargain That Imperils People’s Privacy Rights and Return of Results, 71 Florida L. Rev 1281-1345 (2019)
- Barbara J. Evans, The Genetic Information Nondiscrimination Act at Age 10: GINA’s Controversial Assertion that Data Transparency Protects Privacy and Civil Rights, 60 William & Mary Law Review 2017-2109 (2019)
- Ellen Wright Clayton, Barbara J. Evans, James W. Hazel & Mark A. Rothstein, The Law of Genetic Privacy: Applications, Implications, and Limitations, 6 J. Law and the Biosciences 1-36 (2019)
- Amy L. McGuire, Jessica Roberts, Sean Aas, and Barbara J. Evans, Who Owns the Data in a Medical Information Commons?, 47 Journal of Law, Medicine, and Ethics 62-69 (2019) (reporting results from the NIH-funded Building the Medical Information Commons project)
- Barbara J. Evans & Pilar N. Ossorio, The Challenge of Regulating Clinical Decision Support Software After 21st Century Cures, in Symposium: The 21st Century Cures Act: A Cure for the 21st Century, 44 Am. J. Law & Med. 237-251 (2018)
Book Chapters and Edited Volumes (2017-Present)
- Barbara J. Evans & Frank Pasquale, Product Liability Suits for FDA-Regulated AI/ML Software, in Innovation and Protection: The Future of FDA Medical Device Regulation (I. Glenn Cohen, Nicholson Price, Timo Minssen & Carmel Shachar eds. 2021 forthcoming)
- Barbara J. Evans, Programming Our Genomes, Programming Ourselves: The Moral and Regulatory Limits of Self-Harm in Do-It-Yourself Gene Editing, in Consuming Genomics (I. Glenn Cohen, Hank Greely, Nita Farahany & Carmel Shachar, eds., 2020 forthcoming)
- Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar & Barbara J. Evans, eds. Cambridge University Press, 2019) (edited volume)
- Barbara J. Evans, The Interplay of Privacy and Transparency in Health Care: The HIPAA Privacy Rule as a Case Study, in Transparency in Health and Health Care in the United States: Law and Ethics 30-43 (Cambridge University Press, 2019)
- Barbara J. Evans, Ethical Standards for Unconsented Data Use in Genomic Data Commons, in Routledge Handbook of the Study of the Commons 294-307 (Blake Hudson, Jonathan Rosenblum & Dan Cole, eds. 2019)
- Jim Hawkins, Barbara J. Evans & Harlan Krumholz, Nontransparency in Electronic Health Record Systems, in Transparency in Health and Health Care in the United States: Law and Ethics 273-286 (Cambridge University Press, 2019)
- Barbara J. Evans, Big Data and Individual Autonomy in a Crowd, in Big Data, Health Law, and Bioethics 19-29 (I. Glenn Cohen, Holly Fernandez-Lynch, Urs Gasser & Effy Vayena, eds., Cambridge University Press, 2018)
- Barbara J. Evans & Eric M. Meslin, Biospecimens, Commercial Research, and the Elusive Public Benefit Standard, in Specimen Science 107-124 (Holly Fernandez Lynch, Barbara E. Bierer, I. Glenn Cohen, & Suzanne M.Rivera, eds., MIT Press, 2017)
- Barbara J. Evans, Genomic Data Commons, in Governing Medical Knowledge Commons 74-101 (Katherine Strandburg, Brett Frischmann & Michael Madison, eds., Cambridge University Press, 2017)
Scientific and Medical Writings
- Wylie Burke, Ellen Wright Clayton, Susan M. Wolf, Susan A. Berry, Barbara J. Evans, James P. Evans, Diane Korgiebel, Anne-Marie Laberge, Bonnie S. LeRoy, Amy L. McGuire, Improving Recommendations for Genomic Medicine: Building an Evolutionary Process from Clinical Practice Advisory Documents to Guidelines, 21 Genetics in Medicine 1-8 (June 4, 2019)
- Barbara J. Evans, Parsing the Line Between Professional and Citizen Science Open Peer Commentary on Andrea Wiggins & John Wilbanks, The Rise of Citizen Science in Health and Biomedical Research, 19 American Journal of Bioethics 15-17 (2019)
- Susan M. Wolf & Barbara J. Evans, Defending return of results and data, 362 Science 1255-56 (December 14, 2018)
- Barbara J. Evans & Harlan M. Krumholz, People-powered data collaboratives: fueling data science with health-related experience of individuals, 26 Journal of the American Medical Informatics Association 159-161 (December 20, 2018)
- Susan M. Wolf & Barbara J. Evans, Return of Results & Data to Study Participants, 362 Science 159 – 160 (October 10, 2018)
- Kristen Rosati, Naomi Jorgenson & Barbara Evans, Sentinel Initiative Principles and Policies: HIPAA and Common Rule Compliance in the Sentinel Initiative (2018) (white paper commissioned by the FDA’s Sentinel System) [Link]
- Barbara J. Evans, HIPAA’s individual right of access to genomic data: reconciling safety and civil rights, 102 American Journal of Human Genetics 5-10 (January 4, 2018)
- Barbara J. Evans & Gail P. Jarvik, Impact of HIPAA’s Minimum Necessary Standard on Genomic Data Sharing, Genetics in Medicine, published online ahead of print, Sept. 14, 2017, doi:10.1038/gim.2017.141
- Barbara J. Evans, The Evolving Ethics Challenge in Genomic Science, in Special Issue: Gene Editing (Larry W. Thorpe, ed.), 13 A.B.A. Sci-Tech Lawyer 22-25 (2016)
- Barbara J. Evans, Wylie Burke & Gail P. Jarvik, FDA and Genomic Tests: Getting Regulation Right, 372 New England Journal of Medicine 2258-64 (2015)