Levin College of Law

Barbara J. Evans

Stephen C. O'Connell Chair
Professor of Law
Professor of Engineering, University of Florida Wertheim College of Engineering

Phone:
352-273-0915

About

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, 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 recently served 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.

Education

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.

Courses

  • Biotechnology & Medical AI Policy
  • Health Law Survey
  • Torts

Publications

Selected Legal Writing

  • Barbara J. Evans & Frank Pasquale, Product Liability Suits for FDA-Regulated AI/ML Software, in Innovation and Protection: The Future of Medical Device Regulation 22-35 (I. Glenn Cohen et al. eds., Cambridge University Press, 2022)
  • Barbara J. Evans, Programming Our Genomes, Programming Ourselves: The Moral and Regulatory Limits of Self-Harm in Do-It-Yourself Gene Editing, in Consumer Genetic Technologies: Ethical and Legal Considerations  129-144 (I. Glenn Cohen et al., eds., Cambridge University Press, 2021)
  • 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) (Supplement entitled, “Building a Sound Legal Foundation for Translating Genomics into Clinical Application,” 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) (Supplement entitled, “Building a Sound Legal Foundation for Translating Genomics into Clinical Application,” reporting results from the NIH-funded LawSeqSM project)
  • 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)
  • 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)
  • 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)
  • 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) (open access to full text via pdf link)

Selected Scientific and Medical Writings

  • Marwan K. Tayeh, Margaret Chen, Stephanie M. Fullerton, Patrick R. Gonzales, Samuel J. Huang, Lauren J. Massingham, Julianne M. O’Daniel, Douglas R. Stewart,  Ashlee R. Stiles, Barbara J Evans, on behalf of the ACMG Laboratory Quality Assurance Committee and the ACMG Social, Ethical and Legal Issues Committee, The Designated Record Set for Clinical Genetics and Genomics Testing: A Points to Consider Statement of the American College of Medical Genetics and Genomics (ACMG) (Genetics in Medicine, 2022 forthcoming)
  • Sara H. Katsanis, Peter Claes, Megan Doerr, Robert Cook-Deegan, Jessica D. Tenenbaum, Barbara J. Evans, Myoung Keun Lee, Joel Anderton, Seth M. Weinberg, Jennifer K. Wagner, A Survey of U.S. Public Perspectives on Facial Recognition Technology and Facial Imaging Data Practices in Health and Research Contexts, PLoS ONE 16(10): e0257923 at https://doi.org/10.1371/journal.pone.0257923 (October 14, 2021)
  • Sara H. Katsanis, Peter Claes, Megan Doerr, Robert Cook-Deegan, Jessica D. Tenenbaum, Barbara J. Evans, Myoung Keun Lee, Joel Anderton, Seth M. Weinberg, and Jennifer K. Wagner, U.S. Adult Perspectives on Facial Images, DNA, and Other Biometrics, Institute of Electrical and Electronics Engineers Transactions on Technology And Society, DOI: 10.1109/TTS.2021.3120317 available at https://ieeexplore.ieee.org/document/9576819 (October 18, 2021)
  • Ellen Wright Clayton , Paul S. Appelbaum , Wendy K. Chung , Gary E. Marchant , Jessica L. 14 Roberts, Barbara J. Evans, Does the Law Require Reinterpretation and Return of Revised Genomic Results?,  Genetics in Medicine (January 8, 2021) doi:10.1038/s41436-020-01065- x. Online ahead of print, available at: https://pubmed.ncbi.nlm.nih.gov/33420344/
  • Andrew Paek, Justin A. Brantley, Barbara J. Evans, and Jose L. Contreras-Vidal, Concerns in the Blurred Divisions between Medical and Consumer Neurotechnology, 15(2) IEEE Systems Journal 3069-3080 (2021)
  • 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) available at https://www.nature.com/articles/s41436-019-0549-3
  • 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)