Diane E. Hoffmann is the Jacob A. France Professor of Health Law at the University of Maryland Francis King Carey School of Law and director of the law school’s Law & Health Care Program. She served as associate dean of the law school from 1999 to 2013. She received her law degree from Harvard Law School and her master's degree from Harvard School of Public Health. She was one of the primary authors of Maryland’s Health Care Decisions Act, which establishes standards and procedures for making medical decisions for individuals at the end of life who lack decision-making capacity. She has served as a member of a number of ethics committees including those at the University of Maryland Medical System and the Clinical Center at the National Institutes of Health. She is the founder and director of the Maryland Healthcare Ethics Committee Network, which publishes the Mid-Atlantic Ethics Committee Newsletter. From June 1994 to May 1995, Professor Hoffmann was the acting staff director of the Senate Subcommittee on Aging reporting to U.S. Senator Barbara Mikulski. In 2009, she was selected one of the Maryland Daily Record’s top 100 women. From 2008 to 2014 she served as a member of the board of directors of the American Society of Law, Medicine and Ethics and as president of the board in 2010 and 2011. She is currently a member of the Maryland Stem Cell Commission, the Composite Committee of the U.S. Medical Licensing Exam, the editorial board of the Journal of Medical Regulation, and the scientific advisory board of the Center for Gut Microbiome Research & Education at the American Gastroenterological Association. She is the recipient of three NIH grants, most recently an R01 from the National Human Genome Research Institute to evaluate the regulatory framework for direct-to-consumer microbiome-based tests. Her scholarship has focused generally on end-of-life care, legal obstacles to the treatment of chronic pain, and the regulation of new medical therapies and technologies. Her recent publications have included articles on the regulation of microbiome-based therapies, including probiotics and microbiota transplants, implementation of state allocation of scarce medical resource plans and liability of health care workers during COVID-19, and hospice disposal of opioids. Professor Hoffmann has published numerous articles on health law and policy issues in legal journals as well as scientific and medical journals including Science, JAMA, the NEJM, and the Annals of Internal Medicine.
Handbook for Nursing Home Ethics Committees (1995) (with others).
Stretching the Boundaries of Public Health: Should We Consider End-of-Life Care a Public Health Issue?, in Reconsidering Law and Policy Debates: A Public Health Perspective 40 (John G. Culhane ed., 2010).
The Role and Legal Status of Health Care Ethics Committees in the U.S., in Legal Perspectives in Bioethics: Annals of Bioethics Series 46 (Sandra Johnson & Ana Iltis, eds. 2008) (with Anita Tarzian). Abstract
The Use of Opioid Analgesics: Legal and Regulatory Issues in Complications in Regional Anesthesia & Pain Medicine 353 (Joseph M. Neal & James P. Rothwell eds., 2007).
Toxics: The Wild Card in Boston Harbor Clean-up Litigation, in Of Judges, Politics and Flounders: Perspectives on the Cleaning up of Boston Harbor 299 (Charles Monroe Haar, ed. 1986).
Negotiation and the Rulemaking Process: The 301(h) Case, in Resolving Environmental Regulatory Disputes 222 (Susskind et al. eds., 1983) (with others).
Allocating Scarce Medical Resources During a Public Health Emergency: Can We Consider Sex?, 22 Houston Journal of Health Law & Policy (forthcoming 2023) (with Katherine E. Goodman). Abstract
Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation, JAMA, Jan. 5, 2023, doi:10.1001/jama.2022.23870 (with Katherine E. Goodman & Daniel J. Morgan).
The Future of Stool Banks: A Premature Death?, 76 Food & Drug Law Journal 522 (2022) (with Felicia D. Langel, Francis B. Palumbo & Erik C. von Rosenvinge). Abstract
The Need for Balance in Evaluating Opioid-Prescribing Policies, 112 American Journal of Public Health S28 (2022).
The Woman Who Cried Pain: Do Sex-Based Disparities Still Exist in the Experience and Treatment of Pain?, 50 Journal of Law, Medicine & Ethics 519 (2022) (with Roger Fillingim & Christin Veasley). Abstract
Getting Real: The Maryland Healthcare Ethics Committee Network's COVID-19 Working Group Debriefs Lessons Learned, HEC Forum, Feb. 2021 (with others). Abstract
Reciprocity and Liability Protections During the COVID-19 Pandemic, 51 Hastings Center Report, no. 3, 5 (2021) (with Valerie Gutmann Koch).
Probiotics and the Microbiome: How Can We Help Patients Make Sense of Probiotics? 160 Gastroenterology 614 (2021) (with others).
Legal Challenges to Allocating New COVID-19 Antibody Therapies to Those Who Need Them Most, Health Affairs Forefront, Dec. 24, 2020, https://www.healthaffairs.org/do/10.1377/forefront.20201222.609517/ (with Katherine E. Goodman & Anthony D. Harris).
Probiotics: Promise, Evidence, and Hope, 159 Gastroenterology 409 (2020) (with others).
Karen Rothenberg: Prescient, Perceptive, Persistent and Passionate, 22 Journal of Health Care Law & Policy 141 (2019). Abstract
Introduction: The Promise and Challenges of Microbiome-Based Therapies, 47 Journal of Law, Medicine & Ethics 476 (2019).
The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation, 47 Journal of Law, Medicine & Ethics 482 (2019) (with Alexander Khoruts and Francis B. Palumbo).
Vaginal Microbiota Transplantation: The Next Frontier, 47 Journal of Law, Medicine & Ethics 555 (2019) (with Kevin DeLong, Fareeha Zulfiqar, Anita J. Tarzian, and Laura M. Ensign).
Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies, 47 Journal of Law, Medicine & Ethics 568 (2019) (with others).
Overzealous Use of the CDC's Opioid Prescribing Guideline Is Harming Pain Patients, Stat News (Dec. 6, 2018) (with Kate M. Nicholson and Chad D. Kollas). Abstract
A Proposed Definition of Microbiota Transplantation for Regulatory Purposes, Gut Microbes, Mar. 20, 2017 (with others).
Improving Regulation of Microbiota Transplants, 358 Science 1390 (2017) (with others). Abstract
Stopping Deceptive Health Claims: The Need for a Private Right of Action Under Federal Law, 42 American Journal of Law & Medicine 53 (2016) (with Jack Schwartz). Abstract
The Importance of Including the Deans, Journal of Law, 41 Medicine & Ethics 81 (Supp. 2016).
Access to Essential Medicines in African Countries: An Introduction, 31 Maryland Journal of International Law 1 (2016) (with Peter Danchin). Abstract
Increasing Access to Dental and Medical Care by Allowing Greater Flexibility in Scope of Practice, 105 American Journal of Public Health 1755 (2015) (with Richard J. Manski and Virginia Rowthorn).
Laying the Foundation for an Interprofessional, Comparative Health Law Clinic, 42 Journal of Law, Medicine & Ethics 392 (2014) (with Chikosa Banda and Kassim Amuli). Abstract
Probiotics: Achieving a Better Regulatory Fit, 69 Food & Drug Law Journal 237 (2014) (with others). Abstract
Health Claim Regulation of Probiotics in the USA and the EU: Is there a Middle Way?, 4 Beneficial Microbes 109 (2013). Abstract
Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project, 41 Journal of Law, Medicine & Ethics 454 (2013) (with J. Dennis Fortenberry and Jacques Ravel). Abstract
Probiotics: Finding the Right Regulatory Balance, 342 Science 6156 (2013) (with others). Abstract
A Framework for Human Microbiome Research, 486 Nature 215 (2012) (with others).
Structure, Function and Diversity of the Healthy Human Microbiome, 486 Nature 207 (2012) (with others).
Legal Impediments to the Diffusion of Telemedicine, 14 Journal of Health Care Law & Policy 1 (2011) (with Virginia Rowthorn). Abstract
Medical Marijuana and the Law: Perspective, 362 New England Journal of Medicine 1453 (2010) (with Ellen Weber). Abstract
Teaching Health Law – A Health Law Practice Workshop: Bridging Externship Placements and the Classroom, 37 Journal of Law, Medicine & Ethics 513 (2009). Abstract
Physicians Who Break the Law, 53 St. Louis University Law Journal 1049 (2009). Abstract
Building Public Health Law Capacity at the Local Level, 36 Journal of Law, Medicine & Ethics 6 (2008) (with Virginia Rowthorne). Abstract
Treating Pain v. Reducing Drug Diversion and Abuse: Recalibrating the Balance in Our Drug Control Laws & Policies, 1 St. Louis University Journal of Health Care Law and Policy 231 (2008). Abstract
Achieving Quality and Responding to Consumers - The Medicare Beneficiary Complaint Process: Who Should Respond?, 5 Indiana Health Law Review 9 (2008) (with Virginia Rowthorn). Abstract
Are Health Care Conflicts All That Different? A Contrarian View, 29 Hamline Journal of Public Law & Policy 235 (2008). Abstract
Judging Genes: Implications of the Second Generation of Genetic Tests in the Courtroom, 66 Maryland Law Review 858 (2007). Abstract
Can State Medical Boards Adequately Respond to Reports that Physicians are Inappropriately Prescribing Opioids?, 81 Clinical Pharmacology & Therapeutics 799 (2007).
Who Decides Whether a Patient Lives or Dies?, Trial, Oct. 2006, at 30 (with Jack Schwartz). Abstract
A Statewide Survey Identifying Perceived Barriers to Hospice Use in Nursing Homes, 8 Journal of Hospice & Palliative Nursing 328 (2006) (with Anita J. Tarzian).
The Role of Healthcare Ethics Committee Networks in Shaping Healthcare Policy and Practices, 18 HEC Forum 85 (2006) (with others).
Barriers to Managing Pain in the Nursing Home: Findings from a Statewide Survey, Journal of the American Medical Directors Association, 2005, at S13 (with Anita J. Tarzian)
Future Public Policy and Ethical Issues Facing the Agricultural and Microbial Genomics Sectors of the Biotechnology Industry, 24 Biotechnology Law Report 10 (2005) (with Lawrence Sung). Abstract
Science and Law: When Should Judges Admit or Compel Genetic Tests?, 310 Science 241 (2005) (with Karen Rothenberg). Abstract
Dying in America: An Examination of Policies that Deter Adequate End of Life Care, 33 Journal of Law, Medicine & Ethics 294 (2005) (with Anita Tarzian). Abstract
Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: A Survey of State Medical Boards, 89 Journal of Medical Licensure and Discipline 159 (Dec. 2003) (with A. Tarzian).
Constraints to Prescribing Medications for Pain Treatment in Connecticut, (Pts. 1-3) The Pain Clinic, Dec. 2002, at 28, The Pain Clinic, (Jan./Feb. 2003, at 32, The Pain Clinic, March 2003, at 28 (with Z. Lazzarini and B. Moulton).
Third Party Reimbursement Practice and Their Influence on Pain Management in Connecticut, (Pts. 1-3) 1, The Pain Clinic, Dec. 2002, at 11, The Pain Clinic, Jan./Feb. 2003, at 38, The Pain Clinic, March 2003, at 22.
Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: The Role of State Medical Boards, 31 Journal of Law, Medicine & Ethics 21 (2003) (with A. Tarzian). Abstract
Whose Duty is it Anyway?: The Kennedy Krieger Opinion and its Implications for Public Health Research, 6 Journal of Health Care Law & Policy 109 (2002) (with K. Rothenberg). Abstract
Management of Cancer-Related and Noncancer-Related Chronic Pain in Connecticut: Successes and Failures, 66 Connecticut Medicine 683 (2002) (with A. Tarzian and S. Davidson).
Undertreating Pain in Women: A Risky Practice, Journal of Gender-Specific Medicine, Jan./Feb. 2002, at 10.
The Girl Who Cried Pain: A Bias Against Women in the Treatment of Pain, 29 Journal Law, Medicine & Ethics 13 (2001) (with A. Tarzian). Abstract
Regulating Research with Decisionally Impaired Individuals: Are We Making Progress?, 3 DePaul Journal of Health Care Law 543 (2000) (with Jack Schwartz & Evan G. DeRenzo). Abstract
Are Ethics Committee Members Competent to Consult?, 28 Journal Law, Medicine & Ethics 30 (2000) (with A. Tarzian & J. A. O’Neil). Abstract
Proxy Consent to Participation of the Decisionally Impaired in Medical Research -- Maryland's Policy Initiative, 1 Journal of Health Care, Law & Policy 123 (1998) (with J. Schwartz).
Pain Management and Palliative Care in the Era of Managed Care: Issues for Health Insurers, 26 Journal of Law, Medicine & Ethics 267 (1998). Abstract
Emergency Care and Managed Care -- A Dangerous Combination, 72 Washington Law Review 315 (1997). Abstract
How Close is Enough? Family Relationships and Attitudes Towards Advance Directives and Life-Sustaining Treatment, 3 Journal of Ethics, Law & Aging 5 (1997) (with S.I. Zimmerman & C. Tompkins).
The Guardianship Puzzle: Whatever Happened to Due Process?, 7 Maryland Journal of Contemporary Legal Issues 11 (1996) (with J.L. O’Sullivan). Abstract
The Dangers of Directives or the False Security of Forms, 24 Journal of Law, Medicine & Ethics 5 (1996) (with S.I. Zimmerman & C. Tompkins). Abstract
Testing Children for Genetic Predispositions: Is it in their best interest?, 23 Journal of Law, Medicine & Ethics 331 (1995) (with E.A. Wulfsberg). Abstract
Alpha1-Antitrypsin Deficiency: Impact of Genetic Discovery on Medicine and Society, 271 Journal of the American Medical Association 217 (1994) (with others).
Ethics Committees: Time to Experiment with Standards, 120 Annals of Internal Medicine 335 (1994) (with J. Fletcher).
Mediating Life & Death Decisions, 36 Arizona Law Review 821 (1994). Abstract
The Maryland Health Care Decisions Act: Achieving the Right Balance?, 53 Maryland Law Review 1064 (1994). Abstract
Evaluating Ethics Committees -- A View from the Outside, 71 The Milbank Quarterly 677 (1993). Abstract
Does Legislating Hospital Ethics Committees Make a Difference?: A Study of Hospital Ethics Committees in Maryland, The District of Columbia, and Virginia, 19 Law, Medicine & Health Care 105 (1991).
Regulating Ethics Committees in Health Care Institutions -- Is it Time?, 50 Maryland Law Review 746 (1991). Abstract
The Biotechnology Revolution and Its Regulatory Evolution, 33 Drake Law Review 471 (1989). Abstract
Recent Development, Mexico-United States Pollution Control Agreement, 25 Harvard International Law Journal, 239 (1984).