Nathan Cortez

Full-time faculty

Co-Director of the Tsai Center for Law, Science and Innovation and Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies

Biography

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.

Areas 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

Articles

A Black Box for Patient Safety?, 68 DePaul Law Review 239 (2019) (symposium)

Regulation by Database, 89  University of Colorado Law Review 1 (2018)

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

Substantiating Big Data in Health Care, 14 I/S: A Journal of Law and Policy for the Information Society (2017) (symposium)

The Statutory Case Against Off-Label Promotion, 83 University of Chicago Law Review Online 124 (2016)

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)

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

Do Graphic Tobacco Warnings Violate the First Amendment?, 64 Hastings Law Journal1467-1500 (2013)

A Medical Malpractice Model for Developing Countries?, 4 Drexel Law Review 217 (2011) (symposium article)

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

Can Speech by FDA-Regulated Firms Ever Be Noncommercial?, 37 American Journal of Law & Medicine 388 (2011) (peer-reviewed) (symposium article)

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)

Recalibrating the Legal Risks of Cross-Border Health Care, 10 Yale Journal of Health Policy, Law, & Ethics 1 (2010) (peer reviewed)

International Health Care Convergence: The Benefits and Burdens of Market-Driven Standardization, 26 Wisconsin International Law Journal 646 (2009) (symposium article)

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

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

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) (peer reviewed)

Book Chapters

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 (Homero Rivas & Katarzyna Wac eds., 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)

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)
 
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

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

Presentations

The Evolving Law and Ethics of Digital Health
Wearable Technology in Health Care (WATCH) Society
Stanford Medical School (Jun. 23, 2016)

Regulation by Database
Health Law Workshop
Harvard Law School (Apr. 11, 2016)

Food Labeling and Compelled Speech
Food Law Forum
SMU Law School (Nov. 13, 2016)

Towards a Jurisprudence for Innovation
Digital Broadband Migration Conference:
First Principles for a Twenty-First Century Innovation Policy
Silicon Flatirons Center
University of Colorado School of Law (Feb. 9, 2015)

Gatekeeping for Mobile Health
Center for Law and the Biosciences
Stanford Law School (Jan. 27, 2015)

Gatekeeping Regulation for mHealth
Food & Drug Law Institute (FDLI) and Petrie-Flom Center for 
Health Law, Policy, Biotechnology, and Bioethics
Harvard Law School
Washington, D.C. (Oct. 21, 2014)

Three Decades Plus of FDA Software Regulation
Radcliffe Institute for Advanced Study
Harvard University (Sep. 20, 2013)

Innovations Without Clear Regulatory Precedents
(with Aaron Kesselheim)
Radcliffe Institute for Advanced Study
Harvard University (Sep. 20, 2013)

Is the FDA Equipped to Regulate Mobile Health?
Harvard Law School (June 5, 2013)

The Legal Ambiguities of Medical Tourism
University of North Carolina School of Law (Feb. 1, 2013)

International Health Care Convergence
University of Paris, Hospital Saint-Louis (Aug. 22, 2012)

Immigrants and Health Reform
Hispanic National Bar Association (Sep. 1, 2011)

Cross-Border Health Care and the Hydraulics of Health Reform
Harvard Law School (May 20, 2011)

Can Speech by FDA-Regulated Firms Ever Be Noncommercial?
Boston University School of Law (Feb. 26, 2011)

Is Cross-Border Health Insurance the Answer?
American Society of Law, Medicine, & Ethics
University of Texas School of Law (Jun. 4, 2009)

Emerging Legal Issues with Immigrant Access to Care
Fourth Annual William R. Courtney Lecture in Law
Texas A&M Health Sciences Center, College of Medicine (Mar. 17, 2010)

Ethics in Social Security Cases
U.S. Social Security Administration (Jan. 19, 2010)

The Changing Role of Markets and Competition in U.S. Health Care
Radboud University
Nijmegen, Netherlands (Oct. 2, 2009)

Recalibrating the Legal Risks of Cross-Border Health Care
Yale Law School (Sep. 22, 2009)

The Legal Impact of Voluntary Codes of Conduct in the Health Industry
Food and Drug Law Institute (Sep. 21, 2009)

International Health Care Convergence
University of Wisconsin School of Law (Mar. 7, 2008)