Nathan Cortez
Co-Director of the Tsai Center for Law, Science and Innovation and Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies
Full-time faculty
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Nathan Cortez is the Co-Director of the Tsai Center for Law, Science and Innovation, the inaugural Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies, a former Associate Dean of Research, and a Gerald J. Ford Research Fellow. He teaches and writes in the areas of health law, administrative law, and FDA law. His varied research focuses on emerging markets in health care and biotechnology, regulatory theory, government uses of information, and First Amendment regulation of corporate and commercial speech. Professor Cortez has also become one of the world’s leading legal scholars on medical device regulation, particularly devices that rely on artificial intelligence (A.I.) or machine learning. He has published two recent books: Food and Drug Law (5th edition, 2022) (with Peter Barton Hutt, Lewis Grossman, Erika Lietzan, and Patti Zettler); and Readings in Comparative Health Law and Bioethics (3rd edition, 2019) (with Glenn Cohen and Tim Jost).
Professor Cortez presents his research around the world, to governments, regulators, professional societies, industry, and fellow academics. He has presented work at the law schools of Harvard, Yale, and Stanford, among others, and at the medical schools of Harvard, Stanford, and Vanderbilt, among others. His work is recognized internationally and has been translated into Chinese. Professor Cortez is part of several grant-funded projects sponsored by the U.S. and Canadian governments. He also provides frequent commentary to the media, including the Associated Press, Chicago Tribune, CNN, the Los Angeles Times, the New York Times, NPR, Science, WIRED, and the Washington Post.
Professor Cortez co-founded the Texas Legal Scholars Workshop and the SMU Food Law Forum. He has been a peer reviewer for top legal and medical publications, including Health Affairs, The Lancet, The New England Journal of Medicine, the Oxford and Cambridge University Presses, and the Yale Law Journal. He has been a consultant for the Administrative Conference of the United States (ACUS).
Before joining the SMU faculty, Professor Cortez practiced with the Washington D.C. law firm Arnold & Porter, as part of its pharmaceutical, health care, and biotech practice. He represented clients in health care regulatory matters, with a special emphasis on health care fraud and abuse, FDA enforcement, privacy, and the Medicare and Medicaid programs. He represented clients during litigation, in corporate transactions, during agency enforcement actions, and during congressional investigations and hearings. He received his B.A. from the University of Pennsylvania and his J.D. from Stanford.
Area of expertise
- Administrative Law
- Food and Drug Law
- Health Law
- International Health
- Legislation and Regulation
Education
B.A., University of Pennsylvania
J.D., Stanford Law School
Courses
Administrative Law
Food & Drug Law
Health Law
International & Comparative Health Law
Legislation
Legislation & Regulation
Books
, 5th ed. (Foundation Press 2022) (with Peter Barton Hutt, Lewis Grossman, Erika Lietzan, & Patti Zettler)
(Carolina Academic Press 2020) (with I. Glenn Cohen & Timothy S. Jost)
Articles
Hortatory Mandates, __ George Washington Law Review __ (forthcoming) (with Lindsay F. Wiley)
Who Regulates Abortion Now?, Iowa Law Review (forthcoming 2024) (with Joanna Grossman)
The Disembodied First Amendment, 100 Washington University Law Review 707 (2023) (with William Sage)
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The Law of Licensure and Quality Regulation, 387 New England Journal of Medicine 1053 (2022)
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Presidential Administration and FDA Guidance: A New Hope, 2021 University of Illinois Law Review Online 179 (2022) (with Jacob S. Sherkow)
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Information Mischief under the Trump Administration, 94 Chicago-Kent Law Review 315 (2019)
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Digital Health and Regulatory Experimentation at the FDA, Yale Journal of Health Policy, Law, & Ethics & 21 Yale Journal of Law and Technology 4 (joint issue) (2019)
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A Black Box for Patient Safety?, 68 DePaul Law Review 239 (2019)
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Regulation by Database, 89 University of Colorado Law Review 1 (2018)
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FDA and the Marketplace of Ideas for Medical Products, 45 The Journal of Law, Medicine & Ethics 39, No. 2 supplement (2017)
Substantiating Big Data in Health Care, 14 I/S: A Journal of Law and Policy for the Information Society (2017)
The Statutory Case Against Off-Label Promotion, 83 University of Chicago Law Review Online 124 (2016)
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FDA Regulation of Mobile Health Technologies, 371 New England Journal of Medicine 372 (2014) (with I. Glenn Cohen and Aaron S. Kesselheim)
Regulating Disruptive Innovation, 29 Berkeley Technology Law Journal 173 (2014)
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The Mobile Health Revolution?, 47 U.C. Davis Law Review 1173 (2014)
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Do Graphic Tobacco Warnings Violate the First Amendment?, 64 Hastings Law Journal 1467 (2013)
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A Medical Malpractice Model for Developing Countries?, 4 Drexel Law Review 217 (2011)
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Adverse Publicity by Administrative Agencies in the Internet Era, 2011 BYU Law Review 1371 (2011)
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Can Speech by FDA-Regulated Firms Ever Be Noncommercial?, 37 American Journal of Law & Medicine 388 (2011)
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Embracing the New Geography of Health Care: A Novel Way to Cover Those Left Out of Health Reform, 84 Southern California Law Review 859 (2011)
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Recalibrating the Legal Risks of Cross-Border Health Care, 10 Yale Journal of Health Policy, Law, & Ethics 1 (2010)
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International Health Care Convergence: The Benefits and Burdens of Market-Driven Standardization, 26 Wisconsin International Law Journal 646 (2009)
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The Local Dilemma: Preemption and the Role of Federal Standards in State and Local Immigration Laws, 60 SMU Law Review 47 (2008)
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Patients Without Borders: The Emerging Global Market for Patients and the Evolution of Modern Health Care, 83 Indiana Law Journal 71 (2008)
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The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges, 61 Food & Drug Law Journal 623 (2006) (with William Vodra and David Korn)
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Book chapters
, in (Cambridge University Press 2021) (with Matthew Herder)
, in 125 (I. Glenn Cohen, et al. eds., Cambridge University Press 2018)
, in 249 (Springer 2018)
Analog Agency in a Digital World, in (Columbia University Press 2015)
Globalization, in THE OXFORD HANDBOOK OF U.S. HEALTHCARE LAW (Oxford University Press 2015)
Cross-Border Health Care and the Hydraulics of Health Reform, in (Oxford University Press 2013)
Into the Void: The Legal Ambiguities of an Unregulated Medical Tourism Market, in (Praeger Publishing 2012)
, in (TMC Asser Press 2011)
Biopharmaceuticals: Definition and Regulation, in 3 (John Wiley & Sons 2008) (with Lincoln Tsang)
Other publications
Foreword: The Food Law Era, 19 SMU Science & Technology Law Review 1 (2016)
, Administrative Conference of the United States 1-110 (Sep. 25, 2015), implemented at (Jun. 21, 2016)
Media
New York Times, quoted in (October 2024)
Endpoints News, quoted in (July 2024)
Barron's, quoted in (May 2024)
Bloomberg, quoted in (April 2023)
Washington Post, quoted in (April 2023)
Washington Post, quoted in (April 2023)
NPR Los Angeles, Guest, (April 2023)
Washington Post, quoted in (April 2023)
Associated Press, quoted in (April 2023)
VOX, quoted in (January 2023)