Nathan Cortez

Headshot of Nathan Cortez, faculty member at SMU Dedman School of Law.

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

Email

ncortez@smu.edu
Website

http://nathan.cortez.googlepages.com

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

FOOD AND DRUG LAW: CASES AND MATERIALS, 5th ed. (Foundation Press 2022) (with Peter Barton Hutt, Lewis Grossman, Erika Lietzan, & Patti Zettler)

READINGS IN COMPARATIVE HEALTH LAW AND BIOETHICS (Carolina Academic Press 2020) (with I. Glenn Cohen & Timothy S. Jost)

Articles

Hortatory Mandates, __ George Washington Law Review __ (forthcoming) (with Lindsay F. Wiley)

The Disembodied First Amendment, 100 Washington University Law Review 707 (2023) (with William Sage) 
SSRN | SMU Repository

The Law of Licensure and Quality Regulation, 387 New England Journal of Medicine 1053 (2022)
NEJM | SMU Repository

Presidential Administration and FDA Guidance: A New Hope, 2021 University of Illinois Law Review Online 179 (2022) (with Jacob S. Sherkow)
SSRN | SMU Repository

Information Mischief under the Trump Administration, 94 Chicago-Kent Law Review 315 (2019)
SSRN | SMU Repository

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)
SSRN | SMU Repository

A Black Box for Patient Safety?, 68 DePaul Law Review 239 (2019)
SSRN | SMU Repository

Regulation by Database, 89  University of Colorado Law Review 1 (2018)
SSRN | SMU Repository

FDA and the Marketplace of Ideas for Medical Products, 45 The Journal of Law, Medicine & Ethics 39, No. 2 supplement (2017)
SAGE Journals

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)
SSRN | SMU Repository

FDA Regulation of Mobile Health Technologies, 371 New England Journal of Medicine 372 (2014) (with I. Glenn Cohen and Aaron S. Kesselheim)
New England Journal of Medicine

Regulating Disruptive Innovation, 29 Berkeley Technology Law Journal 173 (2014)
SSRN | SMU Repository

The Mobile Health Revolution?, 47 U.C. Davis Law Review 1173 (2014)
SSRN | SMU Repository

Do Graphic Tobacco Warnings Violate the First Amendment?, 64 Hastings Law Journal 1467 (2013)
SSRN | SMU Repository

A Medical Malpractice Model for Developing Countries?, 4 Drexel Law Review 217 (2011)
SSRN | SMU Repository

Adverse Publicity by Administrative Agencies in the Internet Era, 2011 BYU Law Review 1371 (2011)
SSRN | SMU Repository

Can Speech by FDA-Regulated Firms Ever Be Noncommercial?, 37 American Journal of Law & Medicine 388 (2011)
SSRN | SMU Repository

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)
SSRN | SMU Repository

Recalibrating the Legal Risks of Cross-Border Health Care, 10 Yale Journal of Health Policy, Law, & Ethics 1 (2010)
SSRN | SMU Repository

International Health Care Convergence: The Benefits and Burdens of Market-Driven Standardization, 26 Wisconsin International Law Journal 646 (2009)
SSRN | SMU Repository

The Local Dilemma: Preemption and the Role of Federal Standards in State and Local Immigration Laws, 60 SMU Law Review 47 (2008)
SSRN | SMU Repository

Patients Without Borders: The Emerging Global Market for Patients and the Evolution of Modern Health Care, 83 Indiana Law Journal 71 (2008)
SSRN | SMU Repository

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)
SSRN | SMU Repository

Book chapters

A “DESI” for Devices? Can an Experiment in Pharmaceutical Regulation from the 1960s Improve FDA Oversight of Medical Devices?, in THE FUTURE OF MEDICAL DEVICE REGULATION: INNOVATION AND PROTECTION (Cambridge University Press 2021) (with Matthew Herder)

Introduction:  The Internet of Things (IoT) and Health Data, in BIG DATA, HEALTH LAW, AND BIOETHICS 125 (I. Glenn Cohen, et al. eds., Cambridge University Press 2018)

The Evolving Law and Ethics of Digital Health, in DIGITAL HEALTH: SCALING HEALTH CARE TO THE WORLD 249 (Springer 2018)

Analog Agency in a Digital World, in FDA IN THE 21ST CENTURY: THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES (Columbia University Press 2015)
SSRN

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 THE GLOBALIZATION OF HEALTH CARE:  LEGAL AND ETHICAL ISSUES (Oxford University Press 2013)
 
Into the Void: The Legal Ambiguities of an Unregulated Medical Tourism Market, in RISKS AND CHALLENGES IN MEDICAL TOURISM:  UNDERSTANDING THE GLOBAL MARKET FOR HEALTH SERVICES (Praeger Publishing 2012)
SSRN
 
The Elusive Ideal of Market Competition in U.S. Health Care, in HEALTH CARE AND EU LAW (TMC Asser Press 2011)
 
Biopharmaceuticals: Definition and Regulation, in PRECLINICAL SAFETY EVALUATION OF BIOPHARMACEUTICALS 3 (John Wiley & Sons 2008) (with Lincoln Tsang)

Other publications

Foreword: The Food Law Era, 19 SMU Science & Technology Law Review 1 (2016)
SMU Repository

AGENCY PUBLICITY IN THE INTERNET ERA, Administrative Conference of the United States 1-110 (Sep. 25, 2015), implemented at 81 Fed. Reg. 40,259 (Jun. 21, 2016)