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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 15h

New open-access: "US Food and Drug Administration Officials’ Public Statements on Regulatory Flexibility in New Drug Approval, 2021–2024" by @jsross119.bsky.social , @reshmagar.bsky.social, and @hollylynchez.bsky.social, et al. www.cambridge.org/core/journal...

Independent Articles
US Food and Drug Administration Officials’ Public Statements on
Regulatory Flexibility in New Drug Approval, 2021–2024
Tiffany E. Jiang1 , Julia S. Etkin2, Kennedy Caldwell3,4, Emily Zhang5, Sejin Lee3, Joseph S. Ross6
,
Reshma Ramachandran6 , and Holly Fernandez Lynch3
1Yale School of Medicine, United States; 2Harvard Medical School, United States; 3University of Pennsylvania Perelman School of Medicine, United States; 4University of
Pennsylvania Carey School of Law, United States; 5University of Pennsylvania, United States and 6General Internal Medicine, Yale School of Medicine, United States
Abstract
The US Food and Drug Administration (FDA) has historically exercised substantial regulatory flexibility to adjust the type, amount, and quality
of evidence necessary to support drug approval for areas of unmet need. Our objective was to characterize how FDA officials described and
justified regulatory flexibility in recent public statements. We conducted a thematic analysis of quotations related to regulatory flexibility from
31 FDA officials published in Pink Sheet and STAT, two leading news sources covering FDA, from January 2021 to June 2024. In these
statements, FDA officials typically justified prioritizing patient access to promising treatments over certainty regarding efficacy at the time of
approval, even outside the accelerated approval pathway. Regulators also highlighted confirmatory studies conducted after accelerated
approval as important for establishing drug efficacy. However, they recognized challenges to their completion, including insufficient industry
incentives and FDA enforcement, and were reticent to interpret failed studies as evidence of failed drugs. Overall, in public statements from
2021–2024, FDA officials acknowledged challenges posed by regulatory flexibility but publicly justified its broad use to improve patient access
for serious diseases despite even extended uncertainty. Under the Trump Administration, many offi…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 01/10/2026

New on FirstView: "Evaluating State Laws Protecting Access to Gender-Affirming Care: Considerations for Patients and Providers" by Ryan Knox and Coral Katave. "This essay evaluates the scope of state laws protecting access to [gender-affirming care]..." www.cambridge.org/core/journal...

Independent Articles
Evaluating State Laws Protecting Access to Gender-Affirming Care:
Considerations for Patients and Providers
Ryan Knox1,2 and Coral Katave3
1DePaul University College of Law, Chicago, IL, United States; 2Indiana University Robert H. McKinney School of Law, Indianapolis, IN, United States and 3Texas Tech
University Health Sciences Center El Paso, El Paso, TX, United States
Abstract
In response to an increase in state bans and restrictions of gender-affirming care, many states have enacted laws protecting patients and
providers. This essay analyzes these protective state laws and offers recommendations to strengthen safeguards and ensure continued access to
gender-affirming care nationwide.
Keywords: Gender-Affirming Care; Shield Laws; LGBTQ+ Care; Health Law; Health Policy

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 30/09/2026

New open-access column: "The Henrietta Lacks Case: Ongoing Litigation Seeks Closure" by Allegra Rollo, @shellysimana.bsky.social , and Eli Y. Adashi. "Should the [Lacks] Estate prevail in the pending Ultragenyx litigation, the implications would extend far beyond this case."

Columns: Currents in Contemporary Bioethics
The Henrietta Lacks Case: Ongoing Litigation Seeks Closure
Allegra Rollo1 , Shelly Simana2, and Eli Y. Adashi1
1Brown University Warren Alpert Medical School, United States and 2Boston College Law School, United States
Abstract
The litigation brought by the Estate of Henrietta Lacks against Thermo Fisher Scientific, Ultragenyx Pharmaceutical, and Novartis
Pharmaceuticals reframes benefit-sharing from voluntary institutional ethics into an enforceable legal duty. By pleading a single equitable
claim— unjust enrichment— the Estate seeks to bypass the property and informed-consent doctrines that have defeated comparable tissue-
appropriation suits, while accepting distinctive risks involving remoteness, limitations, causation, and apportionment. This commentary
examines the strategy’s strengths and vulnerabilities through the still-pending Ultragenyx case, and considers its implications for research
consent, prospective benefit-sharing frameworks, and bioethics pedagogy. Whether or not the remaining claim succeeds, the litigation has
already altered the conversation about who should profit from human biological materials.
Keywoards: informed consent; biobanking; unjust enrichment; tissue ownership; Henrietta Lacks

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 22/09/2026

New: "The EHDS Regulation: Health Data at the Crossroads of Patient Autonomy, Data Protection, and Innovation," @esteindl.bsky.social. "This explanatory paper seeks to make the new legal framework accessible to a broad international and interdisciplinary audience." www.cambridge.org/core/journal...

Independent Articles
The EHDS Regulation: Health Data at the Crossroads of Patient
Autonomy, Data Protection, and Innovation
Elisabeth Steindl
Ludwig Boltzmann Institute for Digital Health and Patient Safety, Austria
Abstract
Digitalization and data-driven research are widely recognized as key drivers of innovation in healthcare, with the potential to improve clinical
outcomes, accelerate research, and support evidence-based policymaking. Nevertheless, across jurisdictions, obstacles such as fragmented data
governance, limited interoperability, and tensions between data protection and data reuse continue to hinder the effective use of health data.
The Regulation on the European Health Data Space (Regulation (EU) 2025/327) represents a significant shift in EU health data governance. It
seeks to create a single European market for health data by introducing harmonized rules, shared technical standards, and new institutional
structures, while simultaneously reinforcing patients’ rights, access to their data, and control over its use. This paper aims to provide a clear and
systematic account of the Regulation for a broad international and interdisciplinary audience. It situates the legal piece within its broader
political and legal context, highlighting the factors that shaped its design and providing a comprehensive analysis of its core concepts. Using the
patient opt-out regime as a case study, the paper critically examines the enduring tensions between safeguarding fundamental rights, ensuring
patient autonomy, and fostering innovation and economic objectives, all while accommodating national preferences.
Keywords: Digital Health; European Health Data Space; Patient Rights; Secondary Use; Data Protection

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 15/09/2026

New column on FirstView: "Fifty Years After Estelle v. Gamble — Where Does Carceral Health Law Go from Here?" by James René Jolin, Jenean Docter, and @benjaminabarsky.bsky.social . www.cambridge.org/core/journal...

Columns: Currents in Contemporary Bioethics
Fifty Years After Estelle v. Gamble— Where Does Carceral Health Law
Go from Here?
James René Jolin1, Jenean Docter2, and Benjamin A. Barsky2
1Yale Law School, New Haven, CT, USA and 2University of California College of the Law San Francisco, San Francisco, CA, USA
Abstract
Fifty years ago, the US Supreme Court decided Estelle v. Gamble— a landmark case commonly known for establishing a duty on the government to
provide health services to incarcerated people, whether before or after conviction. In this column, we offer a brief critical reappraisal of Estelle by
reviewing its demanding legal standard and identifying a set of related litigation barriers that stymie the availability of relief in federal court. Given
these constraints, we argue for a carceral health law paradigm that moves beyond the current, dominant focus on litigation. We use Medicaid law
and policy as a case study to explore the potential and drawbacks of a broader administrative structure for carceral health care.
Keywords: carceral health law; Estelle v. Gamble; deliberate indifference; Medicaid reform; Section 1115 Medicaid waivers

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 14/09/2026

New open-access: "Restoring Trust in Health Care: Public Scholarship Based Certification of Key Opinion Leaders with Non-Profit Shared Academic-Patient Governance" by Kim Thompson, Ryan Masotti, Kenneth Carter, Deepa Das Acevedo, Gerard Vong, and Michael Winkler. www.cambridge.org/core/journal...

Independent Articles
Restoring Trust in Health Care: Public Scholarship Based Certification
of Key Opinion Leaders with Non-Profit Shared Academic-Patient
Governance
Kim Thompson1, Ryan Masotti2, Kenneth Carter3,4, Deepa Das Acevedo5,6, Gerard Vong7, and Michael Winkler8
1Department of Family and Preventive Medicine, Emory University School of Medicine, United States; 2Department of Radiology, University of Colorado School of
Medicine, United States; 3Center for Public Scholarship and Engagement, Emory University, United States; 4Department of Psychology, Emory University Oxford College,
United States; 5Emory University School of Law, United States; 6Graduate Division of Religion, Emory University The James T Laney School of Graduate Studies, United
States; 7Center for Ethics, Emory University, United States and 8Department of Radiology and Imaging Sciences, Emory University School of Medicine, United States
Abstract
Collaboration between physician Key Opinion Leaders (KOLs) and the health care industry accelerates the adoption of new therapies, but
public awareness of industry payments and research linking such payments to prescribing behaviors has fueled a sharp decline in trust.
Meanwhile, for-profit, industry-aligned credentialing programs have begun to define and train KOLs with little public accountability. Without
independent alternatives, these models may entrench standards that serve corporate interests over the public good. We review the evolution of
the KOL role, from early communication theory to its integration into pharmaceutical marketing and examine the rise of Public Scholarship
(PS) as an academic movement grounded in beneficence, transparency, and civic accountability. From this analysis, we propose a Key Opinion
Leader Public Scholarship Certification (KOL-PSC) program, governed jointly by academics and patient advocates, to align KOL influence with
public interests. The KOL-PSC model includes a skills-based curriculum in ethical science communic…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 11/09/2026

New Health Policy Portal column on FirstView: "Industry Exposure in Medical Training: The Case for a Conflict-Free Learning Environment" by Joshua D. Hauser, @akesselheim.bsky.social, and Rita Redberg. www.cambridge.org/core/journal...

Columns: Health Policy Portal
Industry Exposure in Medical Training: The Case for a Conflict-Free
Learning Environment
Joshua D. Hauser1, Aaron Seth Kesselheim2, and Rita Redberg1,2
1University of California, San Francisco, San Francisco, CA, United States and 2Brigham and Women’s Hospital, Boston, Massachusetts, United States
Abstract
Conflicts of interest (COI) between physicians and for-profit companies have existed for centuries, but the last decade has dramatically
increased their visibility through the Centers for Medicare and Medicaid Services’ Open Payments database. Despite growing documentation of
COI in academic medical environments— where financial relationships are prevalent and industry payments to trainees exceed millions of
dollars annually— formal COI policies and curriculum in US medical schools have stagnated or weakened since the last major wave of reform
over a decade ago. The authors review the evidence linking industry interactions during medical training to favorable views of pharmaceutical
marketing, greater propensity for continued industry engagement, and increased prescribing of promoted drugs and devices. The authors argue
that medical schools and their governing bodies must implement and enforce meaningful COI policies, meeting at minimum the Association of
American Medical Colleges’ existing recommendations. The authors further recommend that the Liaison Committee on Medical Education
require adherence to these policies for annual accreditation, that research curricula address the influence of funding sources on study design,
and that the Open Payments database be integrated into medical training as a transparency tool. Strengthening COI education and policy is
essential to ensure that the next generation of physicians learns in environments where patient-centered, evidence-based medicine guides
decision-making.
Keywords: Conflicts of Interest; Industry Payments; Medical students; Physicians / ethics

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 02/09/2026

New open-access column: "Assuring Data Authenticity in the Age of Generative AI" by Jeff J.H. Kim, @mhmdhsini.bsky.social , Haavi Morreim, C. K. Gunsalus, and David B. Resnik. Learn about "...the emerging threat posed by GenAI synthetic data and images." www.cambridge.org/core/journal...

Columns: Currents in Contemporary Bioethics
Assuring Data Authenticity in the Age of Generative AI
Jeff J.H. Kim1, Mohammad Hosseini2, Haavi Morreim3, C. K. Gunsalus4, and David B. Resnik5
1University of Illinois Chicago, Chicago, Illinois, USA; 2Northwestern University, Chicago, Illinois, USA; 3Internal Medicine, College of Medicine, The University of
Tennessee Health Science Center, Memphis, Tennessee, USA; 4Coordinated Science Lab, University of Illinois Urbana-Champaign Grainger College of Engineering,
Champaign, Illinois, USA and 5National Institute of Environmental Health Sciences, Durham, North Carolina, USA
Abstract
This commentary examines the challenges that generative artificial intelligence poses to the authenticity and integrity of scientific data. It
proposes data-attestation requirements to strengthen accountability, preserve access to original research records, and help journals and
institutions distinguish authentic evidence from synthetic or fabricated data.
Keywords: Generative AI; Data Authenticity; Data Provenance; Research Misconduct; Research Integrity

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 31/08/2026

New open-access on FirstView: "America First Bilateral Health Agreements Threaten to Undermine the Multilateral Global Health Order" by Sharifah Sekalala, Shajoe J. Lake, Allan Maleche, Maria Birungi, and Frank Ssekamwa. www.cambridge.org/core/journal...

Columns: Global Health Law
America First Bilateral Health Agreements Threaten to Undermine the
Multilateral Global Health Order
Sharifah Sekalala1, Shajoe J. Lake1 , Allan Maleche2, Maria Birungi3, and Frank Ssekamwa4
1University of Warwick, School of Law, United Kingdom; 2KELIN, Kenya; 3Afya Na Haki, Uganda and 4Africa Center for Digital Justice (ADIJUST), Uganda
Abstract
During the second Trump administration, the United States has signed bilateral health agreements with at least 27 states across Africa and Latin
America, reshaping how signatory countries finance, regulate, and monitor their health systems. Grounded in the America First Global Health
Strategy, these agreements are being signed as US withdrawal from WHO restructures global health. This column explores how this turn to
bilateralism risks weakening multilateral legal obligations on capacity development, access and benefit sharing, transparency, and the right to
health.
Keywords: America First Global Health Strategy; Global health law; Bilateral health agreements; Multilateralism; Global health governance

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 27/08/2026

New Global Health Law column: "Planetary Health: A Framework for Expanding the Boundaries of Global Health Law" by Marlies Hesselman, @benjaminmasonmeier.bsky.social, @judithmesquita.bsky.social, Tsung-Ling Lee, @ks7s.bsky.social, et al. www.cambridge.org/core/journal...

Columns: Global Health Law
Planetary Health: A Framework for Expanding the Boundaries of
Global Health Law
Marlies Hesselman1,2, Benjamin Mason Meier3, Judith Bueno De Mesquita4, Luciano Bottini Filho5, Tsung-Ling Lee6
,
Kriti Sharma7, Sam Halabi8, Monique van Cauwenberghe1, Dominique Mollet1, and Gian Luca Burci9
1Groningen Center for Health Law, University of Groningen, Faculty of Law, Netherlands; 2Aletta Jacobs School of Public Health, Planetary Health Theme, University of
Groningen, Netherlands; 3UNC Gillings School of Global Public Health, United States; 4Essex Law School and Human Rights Centre, University of Essex, UK; 5Sheffield
Hallam University, United Kingdom; 6Graduate Institute of Health and Biotechnology Law, Taipei Medical University, Taiwan; 7Global Health Advocacy Incubator;
8Georgetown University O’Neill Institute for National and Global Health Law, United States and 9Graduate Institute of International and Development Studies, Geneva,
Switzerland
Abstract
This article examines how the emerging framework of“Planetary Health” challenges us to reconsider the role and boundaries of global health
law, for example by engaging with systems thinking, eco-centric perspectives, Indigenous knowledge, and newly emerging human rights. How
does planetary health inspire novel thinking or new approaches around the conceptualization, design, implementation and/or interpretation of
global health law and health-related rights, aiming to protect vital ecological foundations or determinants of health?
Keywords: Planetary Health; Global Health Law; Planetary Boundaries; Eco-centric; Systems Thinking; One Health; Indigenous Peoples;
Human Rights

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 13/08/2026

New open-access on FirstView: "Antimicrobial effectiveness within a new paradigm of infrastructure," by Tom Ashfield, @brettfrischmann.bsky.social , @adamdixon.bsky.social , et al. "We propose that AME should be considered a critical economic infrastructure." www.cambridge.org/core/journal...

Independent Articles
Antimicrobial effectiveness within a new paradigm of infrastructure
, Brett Frischmann4, David Jenkins1,5, Adam Dixon2,3, Michael Corley1, and
Tom Ashfield1, Lucy Victoria Naga2,3 Saverio Peter Borriello6
1British Society for Antimicrobial Chemotherapy, United Kingdom; 2Heriot-Watt University, United Kingdom; 3Panmure House, United Kingdom; 4Charles Widger School
of Law, Villanova University, United States; 5University Hospitals of Leicester NHS Trust, United Kingdom and 6Safe Medicines for Animals, United Kingdom
Abstract
Antimicrobials form the backbone of modern medicine and represent a foundational pillar of economic productivity. Overuse and misuse have
led to a rising trend of antimicrobial resistance (AMR), depleting the efficacy of existing antimicrobials, necessitating conservation through
stewardship and renewal through innovation. Poor global access exacerbates these challenges. We introduce the concept of antimicrobial
effectiveness (AME) as a system in which antimicrobials are clinically and microbiologically efficacious against infectious pathogens and
accessible for appropriate use. We frame AME as a global economic infrastructure, demonstrating its role as a key input to health, social, and
economic outcomes and driver of positive spillovers. We investigate the balance between capacity constraints imposed by AMR and the benefits
of maximizing non-discriminatory sharing of AME, exploring how a sustainable management approach comprised of infection prevention,
universal access, stewardship, surveillance, and innovation can conserve AME. We explore economic mechanisms such as internalized
healthcare overheads and hypothecated taxes to align contributions with benefits, ensuring that patients, hospitals, and businesses who rely on
AME help to conserve it. Through identifying social value, patterns of payoffs, and downstream beneficiaries of AME, infrastructure framing
provides a coherent axis to structure action, align incentives, an…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 07/08/2026

New open-access on FirstView: "Leveraging Artificial Intelligence and Natural Language Processing in Legal Epidemiology Studies: Opportunities and Challenges" by Regen Weber-Fares et al. www.cambridge.org/core/journal...

Independent Articles
Leveraging Artificial Intelligence and Natural Language Processing in
Legal Epidemiology Studies: Opportunities and Challenges
, Snigdha Peddireddy2, Mara Howard-Williams3, Gregory Sunshine3
,
Regen Weber-Fares1 , Fallon Julia Cochlin1 Emily Ho3, and Cason Daniel Schmit1
1Health Policy and Management, Texas A&M University School of Public Health, United States; 2Emory University, United States and 3Public Health Infrastructure Center,
Centers for Disease Control and Prevention, United States
Abstract
Legal epidemiology— the study of how laws influence health outcomes— is an emerging field with potential to inform policy and improve
public health. Shortages of specialists who can commit the extensive time required for these analyses has hindered progress in this area. Features
of laws make them ideal candidates for artificial intelligence and natural language processing (AI/NLP) to address these constraints:
standardized format, defined terms, and common terminology. However, there are concerns regarding valid AI/NLP application, especially
given current underreporting of legal research in published policy evaluation studies. Drawing on lessons learned from case deployments and
recent literature, we review opportunities and challenges for methods using AI/NLP in scientific legal research: assessing the scope of legal
documents and data, identifying and collecting primary legal data, developing and applying coding schemes, and implementing quality
controls to ensure the validity of produced legal datasets. We highlight methodologic research areas and innovation in the application of
AI/NLP for scientific studies regarding effects of law on health and indicate methodologic reporting elements that will be essential for the field’
s
innovation. This review provides a method-focused research agenda for AI/NLP in scientific legal epidemiology studies that might accelerate
the field’s growth and effects on evidence-based policy.
Keywords: law; public he…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 06/08/2026

New on FirstView: "Supreme Court Impacts in Public Health Law: 2025–2026," by James G. Hodge, Jr. and Taylor Brown. "Seemingly unmoved and sometimes defiant, the Justices issued a series of decisions in critical cases with mixed effects on the public’s health." www.cambridge.org/core/journal...

Columns: Public Health and the Law
Supreme Court Impacts in Public Health Law: 2025–2026
James G. Hodge Jr. and Taylor Brown
Sandra Day O’Connor College of Law, Arizona State University, United States
Abstract
In an increasingly contemptuous political environment as the nation prepared to celebrate its semisquicentennial on July 4, 2026, the US
Supreme Court capped its 2025–2026 term, which included profound decisions on a series of cases raising significant controversies in health
law and policy. As per Figure 1 and analyses below, major topics addressed by the Court this term include: (1) the scope and limits of
presidential emergency authorities; (2) state debates over LGBTQ+ rights and discrimination in parental and sports-related settings; (3) First
Amendment interests juxtaposed against states’ rights to regulate medical professionals or require vaccinations; (4) expansion of Second
Amendment rights to possess firearms; and (5) state-based product liability and other claims foreclosed via Congress.
Keywords: Supreme Court; cases; public health; constitution; rights
(Received 14 May 2026 UTC; revised 29 June 2026 UTC; accepted 03 July 2026 UTC)

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 18/06/2026

New open-access: "Prohibited AI Practices in Healthcare under the European Artificial Intelligence Act" by @hvkolfschooten.bsky.social. "Understanding how these categorical prohibitions and their exceptions interact is crucial for sectors like healthcare..." #AIAct www.cambridge.org/core/journal...

Prohibited AI Practices in Healthcare under the European Artificial
Intelligence Act
Hannah van Kolfschooten
Centre for Life Sciences Law, University of Basel, Basel, Switzerland
Abstract
The European Union’s Artificial Intelligence Act introduces a novel regulatory category of“unacceptable risk,” prohibiting specific AI practices
that are deemed fundamentally incompatible with human rights and ethical principles. While much attention has focused on the regulation of
high-risk AI systems, particularly in medical contexts, the AI Act’s outright bans under Article 5 have received far less scrutiny. This paper
addresses that gap by examining how these prohibitions apply to healthcare and public health, which are domains defined by rapid
technological uptake, structural vulnerability, and ethically sensitive decision-making. Drawing on the European Commission’s 2025 interpret-
ative Guidelines, the paper argues that several health-related AI applications, such as emotion recognition tools, biometric categorisation systems,
and technologies that influence or target vulnerable populations, may fall within the scope of the bans. It also shows that the Act’s medical and
safety exceptions risk weakening the vulnerability protections that the prohibitions aim to secure. By integrating legal analysis with real-world
health examples, the paper offers a framework for interpreting these prohibitions and assesses how they should guide the ethical boundaries of AI
in healthcare, within and beyond the European context.
Keywords: Artificial Intelligence; AI regulation and ethics; EU AI Act; health technology; digital health

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 10/06/2026

New open-access on FirstView: "Regulatory Guidance for the Return of Raw Genomic Data to Research Participants: A Qualitative Interview Study" by Jane Louise Nielsen, Claire E. Wakefield, @bekmc.bsky.social et al. #ELSI #GenomicData www.cambridge.org/core/journal...

Regulatory Guidance for the Return of Raw Genomic Data to Research
Participants: A Qualitative Interview Study
Jane Louise Nielsen1, Claire E. Wakefield2,3,4, Rebekah McWhirter5, Carolyn Johnston1, Margaret Otlowski1
,
Vanessa Tyrrell6,7, Mark J. Cowley6,7, Katherine M. Tucker6,7,8, Ruth Lyons9, and Anthony J. Gill9,10,11,12
1Faculty of Law, University of Tasmania, Australia; 2Department of Pediatrics, Stanford University and Stanford Medicine Children’s Health, Palo Alto, United States;
3School of Clinical Medicine, University of New South Wales, Australia; 4Kids Cancer Centre, Sydney Children’s Hospital Randwick, Australia; 5Australian National
University, Australia; 6Zero Childhood Cancer Program, Children’s Cancer Institute, Australia; 7University of New South Wales, Australia; 8Sydney Children’s Hospital
Network, Australia; 9Garvan Institute of Medical Research, Australia; 10Department of Anatomical Pathology, Royal North Shore Hospital, Sydney, Australia; 11NSW
Health Pathology, Australia and 12Faculty of Medicine and Health, University of Sydney, Australia
Abstract
This paper reports the results of an Australian qualitative study investigating the return of raw genomic data to research study participants.
Increasing numbers of participants request access to their raw genomic data, although the legal position in relation to whether data should be
returned lacks clarity, particularly in Australia. Interviews were conducted with stakeholders involved in two research studies where
participants have undergone whole genome sequencing: ZERO Childhood Cancer, and the Australian Pancreatic Cancer Genome Initiative.
Four major themes were identified: whether raw genomic data should be returned; reasons for seeking access; risks in returning data; and
processes for return. Our findings indicate that health professionals, scientists, bioinformaticians, patients and patient advocates overwhelm-
ingly support the return of raw data upon request, with ethical imperatives pr…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 04/06/2026

JLME summer issue just landed! Topics include: pharmaceutical corruption, medical-legal partnerships, genetic data governance, structural racism in health laws, and more. 11 of 18 articles are open access, and all are available to subscribers. Read now: www.cambridge.org/core/journal...

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Ally Whelan @amwhelan.bsky.social · 03/06/2026

It’s a beautiful day to do health law! Excited to get #HLP26 started! Welcome to Atlanta and GSU Law to all the attendees!

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SLU Law Center for Health Law Studies @sluhealthlaw.bsky.social · 04/06/2026

Day 2 of #hlp26 is here and first up are @kellygillespie.bsky.social & @profwaltermac.bsky.social on the shared politics of bodily autonomy. This afternoon @robgatter.bsky.social presents on trends in health care financialization. And tonight #SidneyWatson will announce our 25th class of scholars!

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SLU Law Center for Health Law Studies @sluhealthlaw.bsky.social · 05/06/2026

Excellent updates and Q&A on the past year at the FDA and thoughts about what comes next with Michael Sinha, Patti Zettler, Erika Lietzan, Nathan Cortez, and Lewis Grossman. @drsinhaesq.bsky.social @pzettler.bsky.social @nathancortez.bsky.social

Michael Sinha sitting and speaking with Patti Zettler and Erika Lietzan sitting next to him.

The panel sitting and listening to a question from the audience. From left: L Grossman, N Cortez, E Leitzan, P Zettler and M Sinha

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Maya Manian @mayamanian.bsky.social · 04/06/2026

Excited for day 2 of the Health Law Professors Conference at Georgia State Law School! #HLPC26 @jlme-journal.bsky.social

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 04/06/2026

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SLU Law Center for Health Law Studies @sluhealthlaw.bsky.social · 03/06/2026

Day 1 #HLP26 is here! #NicoleTuchinda will present during Session 2E at 2:30 p.m. on the health harms of exclusionary education & then join for the Jay Healey Teaching session at 4 p.m., moderated by #SidneyWatson & some of our favorite #healthlaw people! @jlme-journal.bsky.social

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Cambridge University Press - Law @cambup-law.cambridge.org · 03/06/2026

A new supplemental issue of @jlme-journal.bsky.social is now available! Read about "Supported Decision-Making in Clinical Research," with articles on patients with mental illness, intellectual disabilities, cognitive impairment or other needs: 📚 cup.org/4wUQm5o #ASLME #HealthLaw

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 29/05/2026

NEW ISSUE: Supported Decision-Making in Clinical Research, guest edited by Robert D. Dinerstein, Leslie Francis, and Megan S. Wright. This special issue is dedicated to David T. Wasserman, who had a great impact on the field. www.cambridge.org/core/journal...

Cover of Journal of Law, Medicine & Ethics "Supported Decision-Making in Clinical Research" issue.

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Michael Sinha @drsinhaesq.bsky.social · 28/05/2026

#HLPC26 #HLP26 ASLME @jlme-journal.bsky.social "6B: Turbulence at @fda.gov: The Year in Review and Predicting the Future" Looking forward to joining Lewis Grossman, @pzettler.bsky.social, Erika Lietzan & @nathancortez.bsky.social for this important discussion!

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AUWCL Health Law and Policy Program @auwclhealthlaw.bsky.social · 20/05/2026

We’re excited to sponsor and share our expertise at the @jlme-journal.bsky.social Health Law Professors Conference in Atlanta! Looking forward to connecting and sharing insights! See our faculty lineup below ⬇️ @ashascielzo.bsky.social @mayamanian.bsky.social @jrabrams.bsky.social @auwcl.bsky.social

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 20/05/2026

New: "Difficulties in Honoring Patient Requests for Hospice when Relying on Surrogate Decision-Makers: A Case Study" by Leigh Meyer, Ellen C Meltzer, et al., discusses "how to proceed with decision-making, both ethically and legally, when ...an impasse occurs" www.cambridge.org/core/journal...

Independent Articles
Difficulties in Honoring Patient Requests for Hospice when Relying on
Surrogate Decision-Makers: A Case Study
Leigh Meyer1, Lexi C. White2, Mateo Moss3, Mark N Villanueva4, Timothy J Ingall5, Richard V Guthrie6, Tyler Murphy7
,
Lisa Trost8, Beverly Frase1, Christopher A. Collura1, and Ellen C Meltzer9
1Office of Clinical Ethics, Mayo Clinic Rochester, United States; 2Clinical Ethics, Banner Health, United States; 3Washington and Lee University, Lexington, United States;
4Division of Hospital Internal Medicine, Mayo Clinic Arizona, United States; 5Department of Neurology, Mayo Clinic Arizona, United States ; 6Palliative Medicine, Banner
Health, United States; 7Division Division of Palliative Medicine, Mayo Clinic Arizona, United States; 8Office of Clinical Ethics, Mayo Clinic Arizona, United States and
9General Internal Medicine, Mayo Clinic Arizona, United States
Abstract
Honoring a patient’s wishes for end-of-life care can be challenging if the patient loses decision-making capacity and the identified alternate
decision-maker will not respect the patient’s wishes. This article discusses how to proceed ethically and legally when the alternate decision-
maker and care team disagree about respecting a patient’s end-of-life preferences.
Keywords: surrogate decision making; alternate decision making; patient preference; ethics

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 14/05/2026

New Public Health and the Law column: "Public Health Limits of Medical Freedom" by James Hodge, Jr., Summer Ghaith, and Amirala S. Pasha. "Bodily autonomy is unquestionably constitutionally grounded, but not unconditional." #MedicalFreedom #Vaccination www.cambridge.org/core/journal...

Columns: Public Health and the Law
Public Health Limits of Medical Freedom
James Hodge Jr.1, Summer Ghaith2, and Amirala S. Pasha3
1College of Law, Arizona State University, United States; 2Sandra Day O’Connor College of Law, Arizona State University (ASU), United States and 3Mayo Clinic College of
Medicine and Science, United States
Abstract
Through emerging interpretations of individual“medical freedoms,” a panoply of state legislative bills seeks to undermine long-standing public
health and health care requirements including recommendations to test, screen, treat, and vaccinate persons. To the extent these bills could
upend decades of laws and policies protecting individual and communal health, especially among vulnerable individuals, they threaten the
health— and freedoms— of all persons.
Keywords: Medical freedom; bodily autonomy; exemptions; vaccination; limits
(Received 08 April 2026; revised 08 April 2026; accepted 08 April 2026)

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 13/05/2026

New Health Policy Portal column: "Sociolegal Reproductive Coercion: A Framework for Understanding Structural Pressures on Reproductive Decision-Making" by Laura E. T. Swan, Klaira Lerma, and @lindsaymcannon.bsky.social of @uwmadison.bsky.social , and Fran Linkin. www.cambridge.org/core/journal...

Columns: Health Policy Portal
Sociolegal Reproductive Coercion: A Framework for Understanding
Structural Pressures on Reproductive Decision-Making
Laura E. T. Swan1 , Klaira Lerma2, Lindsay M. Cannon3, and Fran Linkin4
1Reproductive Equity Action Lab, Department of Population Health Sciences, Center for Demography and Ecology, University of Wisconsin-Madison, United States;
2Reproductive Equity Action Lab, Department of Obstetrics and Gyneology, University of Wisconsin-Madison, United States; 3Reproductive Equity Action Lab,
Department of Sociology, Center for Demography and Ecology, University of Wisconsin-Madison, United States and 4State Innovation Exchange, United States
Abstract
Recent US policy changes, including abortion bans and reductions to social safety nets, have intensified structural pressures on reproductive
decision-making. Research has examined interpersonal and clinical forms of reproductive coercion, but legal and policy forces remain
undertheorized. This commentary introduces and defines sociolegal reproductive coercion as occurring when individuals feel pressured or
constrained in their reproductive choices due to legal and policy landscapes that are reinforced and reified by social and cultural forces. These
pressures operate collectively to make certain options, such as long-acting reversible contraception, feel obligatory even when undesired, by
amplifying risks associated with pregnancy, abortion, and parenting. Sociolegal coercion interacts with clinical practice, shaping provider
counseling and narrowing perceived options, and disproportionately affects marginalized communities already subject to systemic inequities.
We situate this construct within existing scholarship on constrained choice and social control, propose a conceptual framework, and outline
implications for research, clinical care, and policy. Recognizing sociolegal reproductive coercion is critical for understanding how health policy
and sociocultural dynamics jointly constr…

000

The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 12/05/2026

New open-access: "The Ethical Justifiability of Patient Restraint in Hospitals: Moving to a Public Health Ethics Approach" by Courtney Coyne and Rosalind McDougall. It defines #restraint as a concept and suggests an approach grounded in public health ethics. www.cambridge.org/core/journal...

Independent Articles
The Ethical Justifiability of Patient Restraint in Hospitals: Moving to a
Public Health Ethics Approach
Courtney Coyne1,2 and Rosalind McDougall1
1The University of Melbourne School of Population and Global Health, Australia and 2Independent Scholar, Australia
Abstract
The use of restraint in hospital settings is divisive, and internationally there are calls for its elimination. However, this is at odds with the
experience of many hospital staff, who consider restraint, at times, a“necessary evil”. In this paper, we explore the definition of restraint and
potential ethical justifications for its use. We argue that the current ethical literature employs two definitions of restraint— outcome-oriented
and intent-oriented— neither of which successfully captures all ethically relevant features of the practice. We propose a new conceptualization
of restraint which centers on the number of individuals impacted by an act of patient restraint— a continuum between therapeutic restraint
and public-safety restraint. Understood in this way, neither the principlist nor human rights frameworks that dominate the current literature
are appropriate for assessing the ethical legitimacy of restraint. We suggest that, given the similarities between restraint and public health
interventions, the use of public health ethics principles to consider the ethical justifiability of restraint in hospitals is a potentially productive
way forward in this controversial area.
Keywords: public health ethics; restraint; bioethics; clinical ethics

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 06/05/2026

New open-access: "Insurrection Powers and the Public’s Health" by James G. Hodge Jr., Taylor Brown, and Kimberly Hartle of @asulaw.bsky.social addresses "Major legal options of presidential emergency powers to address civil uprisings as distinct threats..." www.cambridge.org/core/journal...

Columns: Public Health and the Law
Insurrection Powers and the Public’s Health
James G. Hodge Jr., Taylor Brown, and Kimberly Hartle
ASU Sandra Day O’Connor College of Law, United States
Abstract
President Trump and his administration have repeatedly threatened to invoke insurrection powers and unleash US military and National
Guard members in American cities in response to civil uprisings and alleged interferences with immigration officials’ actions. In so doing, they
raise a specter of significant constitutional clashes over the use of these antiquated emergency authorities. To the extent Congress is unwilling to
constrain presidential discretion, the US Supreme Court may be called on to clarify the scope and limits of Insurrection Act powers.
Key Words: Insurrection; President; Immigration; Powers; Constitution; Limits

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 05/05/2026

New open-access on FirstView: "Minding the Gap: The Absence of Pennsylvania’s Involuntary Commitment Data" by Ari Gluckman, Michele Mekel, and Laura Cabrera of @rockethics.bsky.social . #InvoluntaryCommitment #Privacy www.cambridge.org/core/journal...

Independent Articles
Minding the Gap: The Absence of Pennsylvania’s Involuntary
Commitment Data
Ari Gluckman1, Michele Mekel2, and Laura Cabrera1
1Neuroethics Lab, Department of Engineering Science and Mechanics and Rock Ethics Institute, The Pennsylvania State University, USA and 2Bioethics Program, The
Pennsylvania State University, USA
Abstract
An involuntary commitment is a rights-restrictive procedure that is rarely afforded visibility through useful data. Pennsylvania is a nationally
relevant case study on the promises, perils, and misconceptions surrounding involuntary commitment data. In this study, we survey the
minimal available Pennsylvania data and then contextualize our results within state laws and norms by (1) framing involuntary commitment
data within the state’s gun control agenda, (2) implementing the language of undone science, agnotology, and visibility, and (3) discussing the
rights and social obligations surrounding privacy, confidentiality, and dangerousness. We find that sensitive administrative data is collected at
several points during the involuntary commitment process but is rarely available in a useful, de-identified form. Improved access to useful data
about the commitment population would close a major gap in state and national healthcare delivery, policy, and accountability.
Keywords: Civil commitment; Involuntary commitment; Undone science; Publicly available data; Privacy

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 30/04/2026

New open-access: "AI’s Promise of Healthy Longevity: Exploring the Implications of Extended Lifespans Under International Law" by Jon Truby and Indira Dewi Kantiana. "Do we already have, or should we develop, international law to radically extended lifespans?" #AI www.cambridge.org/core/journal...

AI’s Promise of Healthy Longevity: Exploring the Implications
of Extended Lifespans Under International Law
Jon Truby1 and Indira Dewi Kantiana2
1Centre for International Law, National University of Singapore, Singapore and 2Saw Swee Hock School of Public Health, National University of Singapore, Singapore
Abstract
The World Health Organization has declared 2021–2030 the“Decade of Healthy Ageing”, aiming for the best quality of life through health as
the population ages. Beyond healthy ageing, scientists are adopting artificial intelligence technologies for longevity science which can
foreseeably enable humans to routinely live to 120 years and beyond. With such breakthroughs within reach, the challenges associated with
longevity need to be considered, from the impact on the social system to the possibility of an international law right to longevity, along with
associated considerations such as on sustainability. This article questions whether there already is, or should be, an international human right to
facilitate considerably extended lifespans, along with other relevant legal frameworks.
Keywords: Longevity; Healthy Ageing; human rights; international law; artificial intelligence

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 29/04/2026

New: "The Sufficiency of Disclosure in Medical AI Patents: Evidence from 865 Granted Patents Across the US, China, and the EU" by Ruyi Xiao and Jin Zhang asks "Do current medical AI patents satisfy the legal requirement of sufficiency of disclosure?" #AI #MedicalAI www.cambridge.org/core/journal...

Independent Articles
The Sufficiency of Disclosure in Medical AI Patents: Evidence from
865 Granted Patents Across the US, China, and the EU
Ruyi Xiao1,2 and Jin Zhang1
1School of Civil, Commercial and Economic Law, China University of Political Science and Law, Beijing, China and 2Faculty of Law, National University of Singapore,
Singapore, Singapore
Abstract
The rise of health care AI raises concerns over whether patent disclosure supports reproducibility and legal validity. This study analyzes
865 granted medical AI patents (2015–2025) from the US, China, and the EU using a five-dimensional framework (algorithm transparency,
training data accessibility, model reproducibility, result verifiability, and mathematical support) implemented through NLP-assisted expert
scoring. Results suggest limited technical transparency; approximately 40% of patents score zero in at least two dimensions. Performance varies
significantly: algorithm transparency is relatively strong (>60% score 2), while training data accessibility is less prevalent (4.6% score 2) and
mathematical support is frequently omitted (39.4% score 0). Statistical testing indicates US patents significantly outperform Chinese patents
(p < 0.001), while EU results remain exploratory (N = 31, mean 6.2). These patterns appear associated with institutional factors, strategic
applicant behaviour, and technical complexity. Such limitations may pose risks to enforceability and market development, highlighting the
need for targeted disclosure improvements. This study contributes a replicable framework for translating legal standards into measurable
indicators, providing cross-jurisdictional evidence to guide examination, litigation, and policy refinement in medical AI governance.
Keywords: Medical artificial intelligence; patent disclosure; information transparency; empirical analysis; natural language processing

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 28/04/2026

New open-access on FirstView: "Beyond the Benefit of Doubt: Biases and Credibility in the Adjudication of Chronic Pain" by Rodrigo Deamo Assis, Steven P Cohen, Hance Clarke of @tps-paintoronto.bsky.social , Nimish Mittal, and Mary-Ann Fitzcharles. #ChronicPain www.cambridge.org/core/journal...

Independent Articles
Beyond the Benefit of Doubt: Biases and Credibility in the
Adjudication of Chronic Pain
Rodrigo Deamo Assis1, Steven P Cohen2, Hance Clarke3, Nimish Mittal4, and Mary-Ann Fitzcharles5
1Centre Intégré de Santé et Services Sociaux de l’Abitibi-Témiscamingue, Rouyn-Noranda, Québec, Canada; 2Anesthesiology, Neurology, Physical Medicine and
Rehabilitation, Psychiatry, Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA; 3Transitional Pain Service, Toronto
General Hospital, University of Toronto, Toronto, Ontario, Canada; 4Temerty Faculty of Medicine, Division of Physical Medicine and Rehabilitation, University of Toronto,
Toronto, Ontario, Canada; and 5Department of Rheumatology, McGill University, Montreal, Quebec, Canada
Abstract
Patients living with nociplastic pain are at particular risk of being unfairly judged because their symptoms are subjective and occur without
measurable abnormalities. Nociplastic pain, now recognized as a third category of pain alongside nociceptive and neuropathic pain, arises in the
absence of tissue damage sufficient to explain the clinical presentation. This“
unseen
” pain affects at least ten percent of the population,
commonly involves the musculoskeletal or visceral systems, and leads to substantial suffering and functional impairment. Validation of these
chronic symptoms is often contentious because no objective biomarker or physical sign can reliably confirm their presence or severity. The
concept of illness without measurable parameters challenges clinicians and conflicts with legal systems that rely heavily on objective evidence in
adjudicating health-related questions. Most clinicians have limited training in medicolegal principles, standards of impartiality, or the ethical
distinctions between patient advocacy and objective reporting. These challenges are amplified in cases involving chronic nociplastic pain, where
the lack of observable findings complicates clini…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 27/04/2026

New open access on FirstVIew: "Redefining Pain and Addiction: How Opioid Manufacturers Changed Medical Language to Foster Opioid Use" by Aidan Kaspari, Judy Butler, and Adriane Fugh-Berman explains how #opioid manufacturers seeded marketing messages into medicine. www.cambridge.org/core/journal...

Independent Articles
Redefining Pain and Addiction: How Opioid Manufacturers Changed
Medical Language to Foster Opioid Use
Aidan Kaspari MS1, Judy Butler MS1 , and Adriane Fugh-Berman MD1,2
1Department of Pharmacology and Physiology, Georgetown University Medical Center, Washington, DC, USA and 2Department of Family Medicine, Georgetown
University Medical Center, Washington, DC, USA
Abstract
The role of pharmaceutical companies in promoting overuse of opioids by influencing medical discourse is underexamined. Marketing
messages have been seeded in journal articles, continuing medical education (CME), prescribing guidelines, educational activities, and
professional society recommendations. Terms generated or redefined by industry created a framework for promoting opioids. This paper
focuses on the terms“opiophobia,” “pseudoaddiction,” “breakthrough pain” and“pain is the 5th vital sign.” The reframing of incipient opioid
use disorder as“tolerance” and“dependence” is also discussed. The proliferation of these industry-supported terms within medical discourse
created a false evidence base that opioids were safe and effective for chronic pain and that withholding opioids deprived patients of the best care.
Keywords: Opiophobia; Pseudoaddiction; Breakthrough pain; Opioids; Pharmaceutical marketing

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Reposted by The Journal of Law, Medicine and Ethics

Ally Whelan @amwhelan.bsky.social · 24/04/2026

Providing physiologic support to a brain-dead pregnant person poses complex ethical, legal, &clinical challenges. In this paper, my co-authors & I use a theoretical case to examine these considerations & outline a path forward that respects the pregnant person, their families, & healthcare team

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 24/04/2026

New open-access: "Ethical and Legal Dilemmas in Prolonged Physiologic Support after Brain Death in Previable Pregnancy" by April R. Dworetz, @amwhelan.bsky.social , Ashley Waddell Tingstad, Kara B. Markham, and DonnaMaria E. Cortezzo. #Pregnancy #BrainDeath www.cambridge.org/core/journal...

Independent Articles
Ethical and Legal Dilemmas in Prolonged Physiologic Support after
Brain Death in Previable Pregnancy
, Allison M. Whelan4,5, Ashley Waddell Tingstad6, Kara B. Markham7,8, and
April R. Dworetz1,2,3 DonnaMaria E. Cortezzo9,10,11,12
1Division of Neonatology, Emory University School of Medicine, United States; 2Children’s Pediatric Institute, Children’s Healthcare of Atlanta Arthur M Blank Hospital,
United States; 3Center for Ethics, Emory University, United States; 4School of Law, Georgia State University, United States; 5Bioethics, Harvard Medical School, United
States; 6Wayne State University Law School, Detroit, MI, United States; 7Division of Maternal-Fetal Medicine, University of Cincinnati College of Medicine, United States;
8Division of Maternal-Fetal Medicine, Cincinnati Children’s Hospital Medical Center, United States; 9Division of Neonatology, University of Connecticut School of
Medicine, United States; 10Division of Pain and Palliative Care, University of Connecticut School of Medicine, United States; 11Fetal Care Center, Connecticut Children’s
Medical Center, United States and 12Pediatrics, University of Connecticut School of Medicine, United States
Abstract
Providing physiologic support to a brain-dead pregnant decedent poses complex ethical, legal, and clinical challenges. Understanding these
considerations is necessary to navigate complex discussion and provide appropriate medical care. We use a theoretical case to examine these
considerations and outline a path forward.
Keywords: Maternal Physiologic support after brain death; Pregnancy; Brain death; Personhood; Abortion/pregnancy termination

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 23/04/2026

New open-access: "Beyond Individual Privacy: A Layered Diagnostic Model for Analyzing Genetic Data Governance" by @ruoxinsu.bsky.social . It notes that modern genetic "data’s value is simultaneously collective, strategic, and even geopolitical." #Privacy www.cambridge.org/core/journal...

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 22/04/2026

New open-access on FirstView: "Conceptualizing Reproductive Donation: Developing Models of Egg and Sperm Donation and the Implications for Regulating Information Giving" by @lucyfrith.bsky.social provides a framework for "... critiquing regulation and oversight." www.cambridge.org/core/journal...

Independent Articles
Conceptualizing Reproductive Donation: Developing Models of
Egg and Sperm Donation and the Implications for Regulating
Information Giving
Lucy Frith
Centre for Social Ethics & Policy, Department of Law, University of Manchester, Manchester, United Kingdom
Abstract
There is little consensus on how to regulate information giving in reproductive donation– using donated gametes (eggs, sperm) to have
children. Should gamete donors be anonymous or should donor-conceived individuals have access to their donor’s identity, and at what age?
What information should be available about donor siblings and other donor relations? And, crucially, how should this information giving be
appropriately managed and regulated? Before we can answer these questions, we need to first understand what reproductive donation is. This
paper sets out options for how reproductive donation can be conceptualized and develops a typology of different approaches, by categorizing
reproductive donation into two main models: the biomedical and the psychosocial. These models provide a conceptual framework, a useful
heuristic, for both understanding reproductive donation and critiquing regulation and oversight. The purpose of this paper is not to take a stand
on which model is optimal; this is a matter for further debate. Rather, it provides clarification of what is at stake, and this can form the basis for
coherent and justifiable approaches to the oversight and regulation of reproductive donation, instead of the patchwork of provisions that
currently exist in many jurisdictions.
Keywords: Assisted reproductive technologies; Gamete donation; Gamete donor anonymity; Regulation; Reproduction

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 21/04/2026

On Friday, September 25, t6he Drexel Kline Law Review and Drexel Kline Health Law Program will host a symposium exploring the challenges facing hospitals and the future of hospital care in the United States. Submit your presentation proposal now for consideration. aslme.org/call-for-pro...

aslme.org

Call for Proposals: Under Pressure: The Future of the American Hospital - ASLME

Symposium date: Friday, September 25, 2026 Expressions of interest due: Monday, May 18, 2026 The Drexel Kline Law Review and […]

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 21/04/2026

New open-access on FirstView: "David Wasserman and Supported Decision-Making in Research" by Adam Cureton is a tribute to David Wasserman, who contributed greatly to research in the area of supported decision-making. From the upcoming symposium on the topic. www.cambridge.org/core/journal...

Symposium Articles
David Wasserman and Supported Decision-Making in Research
Adam Cureton
Department of Philosophy, University of Tennessee, Knoxville, United States
Abstract
This memorial essay introduces the Journal of Law, Medicine, and Ethics special issue on supported decision-making in research by honoring
David T. Wasserman (1953–2025), a major organizer of the NIH workshop from which the issue emerged and a coauthor of two papers in the
volume. It situates supported decision-making in research as an emerging approach that aims to make participation by people with cognitive
disabilities possible without displacing their agency through default reliance on legally authorized representatives. The essay highlights
Wasserman’s distinctive contribution to this developing area. He sought a position that is respectful while remaining clear eyed about
exploitation risks and about well-intentioned practices that can undermine a participant’s interests, especially in hard cases where meaningful
authorization is fragile. Drawing on the two coauthored papers in the issue and on colleagues’ recollections, the essay emphasizes Wasserman’
s
commitment to conceptual clarity, workable institutional design, and mentorship through collaboration. It closes by reflecting on his
intellectual virtues, humor, and lasting influence on disability bioethics and research ethics.
Keywords: David T. Wasserman; supported decision making; research ethics; cognitive disability; informed consent

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Reposted by The Journal of Law, Medicine and Ethics

Solomon Center @ YLS @solomonctryls.bsky.social · 20/04/2026

Writing for @jlme-journal.bsky.social, Solomon Center Distinguished Scholar @ninakohn.bsky.social, 2016–18 Fellow Megan Wright, and a co-author explore how to overcome legal barriers to greater use of supported decision-making for people with cognitive disabilities. www.cambridge.org/core/journal...

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Reposted by The Journal of Law, Medicine and Ethics

The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 16/04/2026

New issue available: "2025 Public Health Law Conference: Connection. Collaboration. Community." This symposium compiles many of the timely, thought-provoking papers from the recent @networkforphl.bsky.social conference. #PublicHealth www.cambridge.org/core/journal...

Cover of JLME 2026 Supplement 1: 2025 Public Health Law Conference: Connection. Collaboration. Community.

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 17/04/2026

New open-access on FirstView: "Adults with Intellectual Disability and Consent to Precision Medicine Research: Using Supported Decision-Making to Facilitate First-Person Consent" by Katherine McDonald, Robert Olick, Robert Dinerstein, et al.. www.cambridge.org/core/journal...

Symposium Articles
Adults with Intellectual Disability and Consent to Precision Medicine
Research: Using Supported Decision-Making to Facilitate First-Person
Consent
Katherine McDonald1 , Robert Olick2, Robert Dinerstein3, David Mulcahy4, Mark Cooley1, Eulena Banzer1
,
Maya Sabatello4, and The Project ENGAGE Consortium1
1Syracuse University, United States; 2SUNY Upstate Medical University, United States; 3American University, United States; and 4Columbia University, United States
Abstract
Scientific discoveries and precision medicine research, especially efforts to identify individually tailored approaches to healthcare considering
individual variability in genetics, environmental, and lifestyle factors, have the potential to transform health. This goal is especially critical for
those who experience social injustices and substantial health disparities. Yet the inclusion of adults with intellectual disability in precision
medicine research, a growing field in clinical and translational genomic research, raises ethical, social, and legal concerns about their ability to
make informed decisions to participate, and subsequently whether this population should be excluded altogether or enrolled only via proxy
consent. Both practices demand scrutiny and are sometimes without legal or ethical justification. Supported decision-making, a reasonable
accommodation and relatively recent legal and ethical construct, can facilitate first-person consent and maintain the prospective participant’
s
position as the decision-maker. As such, supported decision-making is a promising development with critical implications for consent to
precision medicine research. Using findings from our national survey with adults with intellectual disability and a legal analysis, our academic-
community research partnership developed recommendations and a tool for using supported decision-making for enrollment in precision
medicine research. We conclude with persistent challenges that need resolving to…

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The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 16/04/2026

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