Curriculum Vitae

Research interests: drug and device law, health law, innovation, intellectual property, torts; administrative law, law and philosophy, legal theory, property.

Academic appointments

• Northeastern University School of Law — Associate Professor of Law (2023–); Co-Director, Amy J. Reed Collaborative for Medical Device Safety (2024–); core faculty, Center for Health Policy & Law and Center for Law, Information & Creativity
• Harvard Law School — Research Fellow & Lecturer on Law, Petrie-Flom Center (2021–2023); Visiting Researcher (2012); Summer Academic Fellow (2011); Teaching Fellow, Harvard College Department of Government (2011–2012)
• George Washington University Law School — Visiting Associate Professor & Frank H. Marks Intellectual Property Fellow (2020–2021)
• University of Kansas School of Law — Visiting Assistant Professor (2019–2020)
• Hanken School of Economics, Helsinki — Fellow (2019–2020)
• University of Navarra, Pamplona — Visiting Professor of Intellectual Property Law (2012)

Education

• Ph.D. (Law), University of Cambridge, Trinity College — Cambridge International Scholar; dissertation on droit moral in copyright
• LL.M., Harvard Law School
• J.D., Chicago-Kent College of Law — high honors, Order of the Coif, Moot Court Honor Society, Dean's Scholarship
• B.A., University of Michigan — high distinction, Political Science; minor in Philosophy

Legal experience and bar admissions

• Simon Law Group LLC — Attorney and Managing Member
• Hon. Martin Ashman, U.S. District Court, Northern District of Illinois — Judicial Law Clerk (2008–2009)
• Dahl & Bonadies — Associate Attorney (2008)
• Brinks, Hofer, Gilson & Lione — Summer Associate (2007)
• Admitted: Illinois; Massachusetts; District of Columbia (inactive)

Publications

Law review articles

1. Data Distortions, Texas Law Review (forthcoming 2026)
2. Off-Label Inducement, Iowa Law Review (forthcoming 2026)
3. Inadvertent Patent Signals, Alabama Law Review (forthcoming 2026) (with Michael Paasche-Orlow & Hooman Noorchashm)
4. IP Pluralism's Puzzle, 103 Texas Law Review 1453 (2025) (with Patrick Goold)
5. Gatekeeping Drugs, 57 Arizona State Law Journal 289 (2025)
6. Copyright's Missing Personality, 62 Houston Law Review 993 (2025)
7. Innovating Preemption or Preempting Innovation?, Northwestern University Law Review Online (2024) (with I. Glenn Cohen & Carmel Shachar)
8. Off-Label Preemption, 2024 Wisconsin Law Review 1079 (2024)
9. On Copyright Utilitarianism, 99 Indiana Law Journal 721 (2024) (with Patrick Goold)
10. Copyright, Moral Rights, and the Social Self, 34 Yale Journal of Law & the Humanities 754 (2024)
11. Off-Label Speech, 72 Emory Law Journal 549 (2023)
12. Off-Label Innovation, 56 Georgia Law Review 701 (2022)
13. Trademark Law & Consumer Safety, 72 Florida Law Review 673 (2020)
14. Analogies in IP: Moral Rights, 21 Yale Journal of Law & Technology 337 (2019)
15. The Confusion Trap: Rethinking Parody in Trademark Law, 88 Washington Law Review 1021 (2013)
16. An Empirical Analysis of Fair Use Decisions Under the Uniform Domain-Name Dispute-Resolution Policy, 53 Boston College Law Review 65 (2012)
17. Explaining the Supreme Court's Shrinking Docket, 53 William & Mary Law Review 1219 (2012) (with Ryan J. Owens)
18. Culture, Creativity, & Copyright, 28 Cardozo Arts & Entertainment Law Journal 279 (2011)
19. Reasonable Perception and Parody in Copyright Law, 2010 Utah Law Review 779 (2010)
20. In Search of (Maintaining) the Truth: The Use of Copyright Law by Religious Organizations, 16 Michigan Telecommunications & Technology Law Review 355 (2010)
21. Teaching Without Infringement: A New Model for Educational Fair Use, 20 Fordham Intellectual Property, Media & Entertainment Law Journal 453 (2010)
22. Mo' Money, Mo' Problems: Nonparty Jurisdiction Over Lawyers' Appeals, 78 University of Cincinnati Law Review 183 (2009)
23. Register Trademarks and Keep the Faith: Trademarks, Religion, and Identity, 49 IDEA 233 (2009)

Other law review publications

• Patients Versus Profits, Vanderbilt Journal of Entertainment & Technology Law (invited symposium) (2025)
• Taxing the Poor Through Real Estate Transfers, Illinois Law Review Online (2020)
• A Legal Stimulus, Northwestern University Law Review of Note (2020)
• Legal Realism Now?, 107 Kentucky Law Journal Online (invited response) (2019)

Peer-reviewed articles

1. A Yellow Book for Medical Device Patents: A Public Health Proposal, JAMA (forthcoming 2026) (with Paasche-Orlow & Noorchashm)
2. How FDA Device Regulation Shapes Medical (Mal)Practice, Annals of Surgery (forthcoming 2026)
3. The Clinician's Role in Safeguarding Brain Data, Neurology (forthcoming 2026) (with Young & Evans)
4. Privacy Considerations of Artificial Intelligence Scribes, NEJM AI (forthcoming 2026) (with Sara Gerke)
5. Establishing Medical Device Transparency at FDA, JAMA (2025) (with Paasche-Orlow & Noorchashm)
6. Recent Caselaw and Liability Risks for Medical AI Developers, Science (2025) (with Sara Gerke)
7. Ambient Listening and Transcription Technologies' Influences on EHR Documentation, 27 AMA Journal of Ethics E787 (2025) (with Sara Gerke)
8. Liability Risks of Clinical Notetaking with AI, JCO Oncology Practice (2025) (with Gerke & Roman)
9. The Case of Snickerwood Soup, Intellectual Property Quarterly (forthcoming 2025) (with Patrick Goold)
10. Chevron's Fall and Its Impact on Medical Artificial Intelligence, Health Affairs Forefront (2024) (with Sara Gerke)
11. The Effect of Loper Bright on FDA's Regulation of Lab-Developed Tests, JAMA (2024) (with Young)
12. Developing Drugs for a Developing Climate, Health Affairs Forefront (2024) (with I. Glenn Cohen)
13. New Drug Development Paradigms? Opportunities and Uncertainties with Government Programs, Science Translational Medicine (2024) (with Liddicoat, Hamidzadeh, Liddell, Schito, Aboy & Minssen)
14. Doctors as Device Manufacturers? FDA Regulation of Clinician-Generated Innovation, 52 Critical Care Medicine 1 (2024) (with Young)
15. Using Digital Technologies to Diagnose in the Home, npj Digital Medicine (2024) (with Raza, Shachar & Cohen)
16. Lucky IP, 42 Oxford Journal of Legal Studies 843 (2022) (with Patrick Goold)
17. Skating the Line Between General Wellness Products and Regulated Devices, 9 Journal of Law & the Biosciences 1 (2022) (with Cohen & Shachar)
18. Should Alexa Diagnose Alzheimer's? Legal and Ethical Issues, 3 Cell Reports Medicine 1 (2022) (with Evans, Shachar & Cohen)
19. Unsettled Liability Issues for Pre-diagnostic Wearables, JAMA (2022) (with Cohen & Shachar)
20. At-Home Diagnostics and the Device vs Wellness Line, 327 JAMA 523 (2022) (with Cohen & Shachar)
21. The Hospital-at-Home Presents Novel Liabilities, Nature Medicine (2022) (with Cohen, Offodile & Balatbat)
22. Patient Data Ownership: Who Owns Your Health?, 8 Journal of Law & the Biosciences 1 (2021) (with Liddell & Lucassen)
23. Telehealth to Address Health Disparities, 49 Journal of Law, Medicine & Ethics 415 (2021) (with Carmel Shachar)

Book chapters

• Physician & Manufacturer Liability for Remote Patient Monitoring, in Digital at Home Diagnostics: Ethical, Legal, and Regulatory Issues (Cohen, Kramer, Adler-Milstein & Shachar eds.) (2024) (with Aaron Kesselheim)
• Assessing Public and Private Rights of Action to Regulate Health Data, in Data Sharing in Health Sciences and Law (Companucci & Minssen eds., Springer) (2023) (with Cohen & Shachar)
• Information Capacity, Regulation, & Certification Marks, in Cambridge Handbook on the Law & Economics of Trademarks (Lunney ed.) (2023)

Other publications

• Diagnosing in the Home: Ethical, Legal, and Regulatory Challenges (white paper), Petrie-Flom Center (2023)
• Regulatory Roadmap for Digital Diagnostics (policy paper), Petrie-Flom Center (2023)
• The Devil is in the Details with Biden's Free COVID Testing Plan, Bill of Health (Dec. 2021)
• Pandemic Diagnostics: Present and Future Implications of Self-Testing Reimbursement, Bill of Health (July 2021)
• Legal Scholarship Highlight: Empirical Analysis of the Court's Shrinking Docket, SCOTUSblog (June 2012) (with Ryan J. Owens)
• A Patient's Guide to Thoracic Outlet Syndrome (book) (2018)

Works in progress

• Innovation Information
• Copyright, Moral Rights, and Subjective Authorial Harm
• Federal Malpractice (with Noorchashm & Paasche-Orlow)
• Memoranda of Innovation
• Prescribing Liability for Black Box AI (with Gerke)
• Can Robots Have Law? (with Tobia)

FDA citizen petitions

• Request for investigation of robotic nipple-sparing mastectomy (Mar. 2, 2026)
• Request for Class I recall of da Vinci Model 5 Surgical Systems (Feb. 5, 2026)
• Request to revise labeling of Psychemedics cannabinoid hair-testing device (Oct. 17, 2025)
• Request to recall Symvess products (Aug. 29, 2025)
• Request to reclassify VariTrax Sternal CircumFixation System (July 3, 2025)
• Off-label use of da Vinci robotic system for hybrid convergent cardiac ablation (May 1, 2025)
• Request for safety communications and guidance on robotic mastectomy (Feb. 18, 2025)

Presentations

2026

• Innovation Information — Boston University School of Law WIP IP Scholars Workshop
• Innovation Information — Stanford Law School Innovation Biolaw Workshop
• Copyright, Moral Rights, and Subjective Authorial Harm — University of Cambridge IP Workshop; City University London Faculty Workshop
• Data Distortions — University of Miami Legal Theory Workshop (invited); Yale Law School Information Society Project (invited); University of Texas School of Law (invited); Saint Louis University Health Law Scholars (invited)
• Malpractice by Regulation — Touro Law Center Faculty Workshop (invited)
• Postmarket Information on Medical Device Safety — Saint Louis University School of Law (invited)
• IP Pluralism's Puzzle — University of Texas School of Law (invited)

2025

• Patients Versus Profits — Vanderbilt Law School (invited)
• Off-Label Drug Use: Global Trends & Lessons for Regulators — Health Insurance Review & Assessment Service, Seoul (invited keynote)
• Liability for AI/ML Medical Products in the U.S. — Life Sciences Summit, Brussels
• Inadvertent Patent Signals — Northwestern Junior Faculty Forum for Law & STEM (selected); UC Berkeley IP Scholars Conference
• Off-Label Inducement — University of Illinois (invited); University of Maryland Carey Law (invited); Seton Hall Health Law WIP (selected); Penn Junior Faculty Forum for Law & STEM (selected); Boston University IP Workshop (invited); UMass Law (invited); Northeastern RIBS Workshop

2024

• Developing Drugs for a Developing Climate — Stanford Law & Biosciences Workshop
• Copyright's Missing Personality — UNH Law Review Symposium; Penn Ninth Copyright Scholarship Roundtable (selected); GW Law IP Speaker Series (invited); Northeastern Junior Scholars Conference; New England Law Art Law Roundtable (selected)
• Off-Label Preemption — AALS New Voices (Law, Medicine & Health Care; Litigation; Administrative Law); Northeastern Health Law Roundtable; ASLME Health Law Professors Conference (Maryland); Stanford Law & Biosciences Workshop; Georgia State RIBS Workshop
• Law's Grammar — Northeastern Junior Scholars Conference; AALS Jurisprudence Junior Scholars Workshop
• AI and Medicine in the Post-COVID Era — Harvard Medical School / MGH / Mass General Brigham

2023

• Gatekeeping Drugs — ASLME Health Law Professors Conference (Arizona State); Iowa RIBS Workshop; Stanford Law & Biosciences Workshop; Saint Louis WIP IP Colloquium; Northeastern Faculty Colloquium (invited)
• On Copyright Utilitarianism — Penn Eighth Copyright Scholarship Roundtable (selected); Suffolk WIP IP Colloquium; Stanford IPSC; Colorado Society for Empirical Research in Copyright
• Who Owns the Content of Generative AI? — Weill Cornell Medicine–Qatar
• Drug Reimbursement by Public Payors in the U.S. — C-Path Institute CURE Drug Repurposing Collaboratory (invited)
• Should Alexa Diagnose Alzheimer's? — Advanced Healthcare at Home Summit (invited)

2022

• Should Alexa Diagnose Alzheimer's? — Digital Medicine Society (invited)
• Devices as Billboards — Iowa RIBS Workshop (invited)
• The Legal and Policy Landscape of Drug Repurposing — C-Path Institute (invited)
• Informational Capacity, Regulation, and Certification Marks — Harvard/Penn/NYU Trademark Scholarship Roundtable (selected); Texas A&M Law & Economics of Trademarks Conference (invited)
• Emerging Trends in In-Home Digital Diagnostics — Loyola Chicago (invited)
• Lucky IP — UNH IP Roundtable (selected)

2021

• Off-Label Speech — Loyola Chicago Wiet Life Science Law Scholars Workshop (selected); ASLME Health Law Professors Conference; Seton Hall Health Law WIP Retreat (selected)
• Off-Label Innovation — University of Cambridge (invited); AU/Utah/Texas A&M WIP IP Colloquium; AALS New Voices in IP; Stanford IPSC Junior Scholars Workshop
• Drug Reimbursement: On- and Off-Label — C-Path Institute (invited)

2020

• Provider-Based Solutions to Problems with Off-Label Prescriptions — IP & Innovation Researchers of Asia Conference
• Innovation, Off-Label Prescribing, and IP Regimes; Distributing IP; Problems in Theory: IP — Hanken School of Economics, Helsinki (invited)
• The Syntactic Structure of Legal Rights — Cambridge Political Philosophy Workshop; University of Surrey H.L.A. Hart Seminar
• Copyright's Memory-Based Rights — Marquette IP Mosaic Conference; George Mason Colloquium on Philosophical Approaches to IP (invited)
• A Structural Analysis of IP Law — University of Kentucky (invited)
• Problems in Theory: IP — Santa Clara WIP IP Colloquium; UNH IP Mosaic Conference
• Trademark Law & Consumer Safety — DePaul IPSC; Rx Marks — DePaul (invited)

2009–2019

• Early Moral Rights Theorists in Copyright Law — University of Cambridge (2019)
• Aspects of IP Law and Licensing in the U.S. and Europe — European School of Economics (invited, 2019)
• The Confusion Trap — Oxford IP Discussion Group (2018)
• An Empirical Analysis of Fair Use Under the UDRP — DePaul IPSC; Harvard Empirical Analysis of Law Seminar (2011)
• Culture, Creativity & Copyright — Boston University WIP IP Colloquium (2011)
• Reasonable Perception and Parody — Drake IP Scholars Roundtable (2009); Teaching Without Infringement — Seton Hall WIP IP (2009); Copyright Use by Religious Organizations — Cardozo IPSC (2009)

Grants

• Arnold Ventures — Principal Investigator, Project on Medical Device Safety, Northeastern University School of Law (2024–)
• Horizon Europe — CLASSICA Project (2024–)
• Gordon and Betty Moore Foundation — Diagnosing in the Home, Harvard Law School (2021–2024)
• Academy of Finland — FAME-IP, Hanken School of Economics (2019–2020)

Awards and fellowships

• Health Law Scholar, Saint Louis University School of Law / ASLME (2025)
• Faculty Fellowship Award, Center for Health Policy & Law, Northeastern (2023–2024)
• Edison Fellow, George Mason University Scalia Law School (2023–2024)
• Wiet Life Sciences Law Scholar, Loyola University Chicago (2020)
• Cambridge International Scholar, University of Cambridge (full merit scholarship and stipend)
• Summer Academic Fellow, Harvard Law School (2010–2011)
• Hanken Foundation Scholarly Award
• 1st Place, IDEA Student Writing Competition
• Harvard Journal of Law & Technology (member)

Courses taught

• Northeastern University School of Law: Torts; Drug and Device Innovation; Administrative Law
• Harvard Law School: Drug and Device Innovation
• George Washington University Law School: Trademark Law
• University of Kansas School of Law: Torts; Patent Law; Criminal Law

Professional service

• Editorial Board, Food & Drug Law Journal (2022–)
• Peer reviewer: Food & Drug Law Journal, JAMA, Journal of Intellectual Property Law & Practice, Journal of Law & the Biosciences, Journal of Law, Medicine & Ethics, Jurimetrics, New England Journal of Medicine, npj Digital Medicine, Oxford Journal of Legal Studies, Science
• Co-organizer, Texas Law Review symposia: Law and the Politicization of Scientific Expertise (2026); The Politics of IP (2025)
• Founder and organizer, Junior Scholars Conference, Northeastern University School of Law (2024, 2025)
• Organizer, Regulation, Innovation & the Biosciences Workshop, Northeastern (2024); Junior Scholars Workshop (virtual, 2020–2021)
• Faculty advisor/coach: Health Law Regulatory & Compliance Competition (2024, 2025); USPTO Patent Drafting Competition (2024); Saul Lefkowitz Trademark Moot Court
• Preceptor, JD/MPH capstone, Northeastern; student mentor, Petrie-Flom Center, Harvard Law School (2021–2024)
• CURE Drug Repurposing Collaboratory (2021–2024); Direct-to-Consumer Microbiome-Based Tests Working Group (2022)
• Founder & President, Project TCF20 (2024–)
• Commentator, Seton Hall Health Law WIP Retreat (2022)
• Pro bono attorney, Lawyers for the Creative Arts (2016–2020)

Media

• Medscape — Health System Sued Over AI Scribe Technology, Patient Consent (Jan. 2026)
• Medical Economics — The new malpractice frontier: Who's liable when AI gets it wrong? (Oct. 2025)
• Bloomberg — The Implants Were Supposed to Dissolve. They Didn't (Sept. 2025)
• Regulatory Focus — FDA should establish a public database of device labels, experts say (June 2025)
• Medscape — FDA Faces Blowback Over Regulation of Lab-Developed Tests (Sept. 2024)
• Endpoints News — FDA hints at what Chevron's elimination means in new SCOTUS filing (Aug. 2024)
• Vox — The Supreme Court: The most powerful, least busy people in Washington (May 2024)
• Bustle — What Prenuvo Scans Won't Tell You (Feb. 2024)
• Wired — The Bruce Willis Deepfake Is Everyone's Problem (Oct. 2022)
• Neo.Life — More At-Home Tests Are Heading Your Way (Sept. 2022)
• Inverse — Alexa Could Diagnose Alzheimer's and Other Brain Conditions – Should It? (July 2022)
• The Verge — FTC resurrects a decade-old rule as a guardrail on the health app explosion (Sept. 2021)
• Forbes — Your Property Taxes Are Likely Still Due (Apr. 2020)
• Wired — The messy legal scrap to bring celebrities back from the dead (Nov. 2019)

Last updated 2026-09-19. The PDF is the authoritative version.