The Journal of Law, Medicine and Ethics's Avatar

The Journal of Law, Medicine and Ethics

@jlme-journal

The Journal of Law, Medicine & Ethics (JLME) is a leading peer-reviewed journal for research at the intersection of law, health policy, ethics, and medicine.

308
Followers
113
Following
181
Posts
16.12.2024
Joined
Posts Following

Latest posts by The Journal of Law, Medicine and Ethics @jlme-journal

Independent Articles
Body and Soul: How Neuroimaging Should Revise Tort Perspectives
on PTSD
Alexandra Midler
Department of Biology, Stanford University, United States
Abstract
Tort law has traditionally prioritized physical over emotional injury claims, due in part to insufficient methods of quantifying the latter. But
advances in neuroimaging now make it possible to measure the distinct (and often chronic) neurological damage caused by PTSD, suggesting
that it should be treated as both a physical and emotional harm. I argue that this recategorization may help PTSD victims win just restitution,
especially for those from marginalized groups whose suffering has traditionally been overlooked and underappreciated by the legal system.
Lingering probative and prejudicial flaws will likely limit current judicial applications of PTSD neuroimaging to citations of aggregate research.
Until the technology improves in accuracy and sensitivity, individual PTSD neuroimaging on tort plaintiffs will fail to meet most state and
federal evidentiary standards. When it does achieve sufficient reliability, neuroimaging precedent for traumatic brain injury may offer guidance
on how to incorporate the technology without creating a“CSI effect” that harms plaintiffs unable to access or afford brain scans. PTSD
neuroimaging may ultimately foster a greater appreciation for the physical toll of psychological illnesses, catalyzing the movement to dismantle
the mind-body divide in tort jurisprudence.
Keywords: PTSD; emotional injury; tort law; neuroimaging; solitary confinement; domestic abuse; minorities

Independent Articles Body and Soul: How Neuroimaging Should Revise Tort Perspectives on PTSD Alexandra Midler Department of Biology, Stanford University, United States Abstract Tort law has traditionally prioritized physical over emotional injury claims, due in part to insufficient methods of quantifying the latter. But advances in neuroimaging now make it possible to measure the distinct (and often chronic) neurological damage caused by PTSD, suggesting that it should be treated as both a physical and emotional harm. I argue that this recategorization may help PTSD victims win just restitution, especially for those from marginalized groups whose suffering has traditionally been overlooked and underappreciated by the legal system. Lingering probative and prejudicial flaws will likely limit current judicial applications of PTSD neuroimaging to citations of aggregate research. Until the technology improves in accuracy and sensitivity, individual PTSD neuroimaging on tort plaintiffs will fail to meet most state and federal evidentiary standards. When it does achieve sufficient reliability, neuroimaging precedent for traumatic brain injury may offer guidance on how to incorporate the technology without creating a“CSI effect” that harms plaintiffs unable to access or afford brain scans. PTSD neuroimaging may ultimately foster a greater appreciation for the physical toll of psychological illnesses, catalyzing the movement to dismantle the mind-body divide in tort jurisprudence. Keywords: PTSD; emotional injury; tort law; neuroimaging; solitary confinement; domestic abuse; minorities

New on FirstView: "Body and Soul: How Neuroimaging Should Revise Tort Perspectives on PTSD" by Alexandra Midler. "It no longer makes sense to define the disorder as an exclusively emotional injury when each of its symptoms correlates to clear damages in the brain."
www.cambridge.org/core/journal...

06.03.2026 14:54 👍 0 🔁 0 💬 0 📌 0

Really enjoyed the discussions of the recent @euhealthgov.bsky.social webinar (and also contributing to the Symposium!)

Webinar: www.youtube.com/watch?v=RHmj...

Write-up: healthgovernance.ideasoneurope.eu/2026/02/27/s...

01.03.2026 18:09 👍 2 🔁 2 💬 0 📌 0

This entry is from a paper published in JLME. Excited to see how it performs in STAT Madness!

03.03.2026 16:58 👍 0 🔁 0 💬 0 📌 0
Summary: ‘Public Health, Markets, and Law’, a Symposium in the Journal of Law, Medicine, and Ethics – EU Health Governance Network

The recording & blog of our webinar launching @jlme-journal.bsky.social Symposium, "Public Health, Markets, & Law" is now here!

Many thanks to all speakers for a great discussion!

euhealthgov.org/summary-publ...

@ideasoneurope.bsky.social @uaces.bsky.social

01.03.2026 17:51 👍 0 🔁 2 💬 0 📌 1
Independent Articles
“We Playin’ Chess But You Give Me a Checker Piece”: A Portrait of
Structural Racism Ingrained in Overdose Good Samaritan Laws
Through Semi-Structured Interviews
Dong-Chul Seo1 , Naomi Satterfield1, Shin Hyung Lee1, Charlotte Crabtree2, and Nicki Cochran2
1Applied Health Science, Indiana University Bloomington School of Public Health, United States and 2Overdose Lifeline, Inc., United States
Abstract
By centering the experiences of minoritized community members, this study explores how Good Samaritan laws (GSLs) impact health
behaviors related to opioid overdose response. Most states have GSLs that address overdose response. However, their scope can perpetuate
structural racism by extending inequitable protection through rigid requirements and exclusions. In this paper, we look at Indiana’s GSL,
Aaron’s Law, and consider how its limitations impact Black Indianapolis residents. We analyzed 50 semi-structured one-on-one interviews
with Black residents of four urban Indianapolis zip code areas. We engaged the Health Belief Model using directed qualitative content analysis
to consider participants’ evaluation of perceived benefits and barriers as they relate to calling 911 following an opioid overdose. We explore
participants’ feelings about calling 911 and interacting with law enforcement, and their understanding of Aaron’s Law and its practical
application in their neighborhoods. We demonstrate structural racism’s presence in the impressions and applications of policies and highlight
how addressing them can improve health outcomes in minoritized communities. Finally, we make recommendations for GSLs nationwide that
address the impact of structural racism on overdose fatalities and strengthen their protections, making laypeople more likely to call 911 after an
overdose.
Keywords: community-based participatory research; opioid overdose; overdose fatality prevention; Good Samaritan Laws; qualitative

Independent Articles “We Playin’ Chess But You Give Me a Checker Piece”: A Portrait of Structural Racism Ingrained in Overdose Good Samaritan Laws Through Semi-Structured Interviews Dong-Chul Seo1 , Naomi Satterfield1, Shin Hyung Lee1, Charlotte Crabtree2, and Nicki Cochran2 1Applied Health Science, Indiana University Bloomington School of Public Health, United States and 2Overdose Lifeline, Inc., United States Abstract By centering the experiences of minoritized community members, this study explores how Good Samaritan laws (GSLs) impact health behaviors related to opioid overdose response. Most states have GSLs that address overdose response. However, their scope can perpetuate structural racism by extending inequitable protection through rigid requirements and exclusions. In this paper, we look at Indiana’s GSL, Aaron’s Law, and consider how its limitations impact Black Indianapolis residents. We analyzed 50 semi-structured one-on-one interviews with Black residents of four urban Indianapolis zip code areas. We engaged the Health Belief Model using directed qualitative content analysis to consider participants’ evaluation of perceived benefits and barriers as they relate to calling 911 following an opioid overdose. We explore participants’ feelings about calling 911 and interacting with law enforcement, and their understanding of Aaron’s Law and its practical application in their neighborhoods. We demonstrate structural racism’s presence in the impressions and applications of policies and highlight how addressing them can improve health outcomes in minoritized communities. Finally, we make recommendations for GSLs nationwide that address the impact of structural racism on overdose fatalities and strengthen their protections, making laypeople more likely to call 911 after an overdose. Keywords: community-based participatory research; opioid overdose; overdose fatality prevention; Good Samaritan Laws; qualitative

New: “'We Playin’ Chess But You Give Me a Checker Piece': A Portrait of Structural Racism Ingrained in Overdose Good Samaritan Laws Through Semi-Structured Interviews" by Dong-Chul Seo, @naomicarmen.bsky.social , Shin Hyung Lee, Charlotte Crabtree, & Nicki Cochran.
www.cambridge.org/core/journal...

24.02.2026 14:58 👍 0 🔁 1 💬 0 📌 0

A new issue of @jlme-journal.bsky.social is now available!

Read articles on the new VSED Advance Directive, ethics and Alzheimer's, upholding autonomy, oncofertility, medical-legal partnerships in HIV care, and more:

📚 https://cup.org/46MBZ7I

#PublicHealth #HealthLaw

15.02.2026 17:23 👍 0 🔁 1 💬 0 📌 0
Diverting Data and Drugs: A Narrative Review of the Mallinckrodt Documents | Journal of Law, Medicine & Ethics | Cambridge Core Diverting Data and Drugs: A Narrative Review of the Mallinckrodt Documents - Volume 52 Issue 1

Read the article from @jlme-journal.bsky.social : doi.org/10.1017/jme....

12.02.2026 18:41 👍 0 🔁 1 💬 0 📌 0
Independent Articles
Bribery and the Global Pharmaceutical Industry: An Exploration of
Patterns and Penalties in the Organisation for Economic Cooperation
and Development Reports
Jillian Kohler1, Anaam Khan1, and Andrea Bowra2
1Leslie Dan Faculty of Pharmacy, University of Toronto, Canada and 2Dalla Lana School of Public Health, University of Toronto, Canada
Abstract
Bribery by the pharmaceutical industry is one common manifestation of corruption that can be found in a pharmaceutical system. This study
analyzes patterns of bribery in the global pharmaceutical industry through a systematic review of Organisation for Economic Co-operation and
Development (OECD) Working Group on Bribery Phase Reports published between 1999 and February 2025. These reports document
investigations and enforcement actions related to bribery across jurisdictions. An inductive thematic analysis was used to identify key patterns
in cases implicating pharmaceutical firms. We found patterns across many of the cases we studied. For example, bribery was often approved by
high-ranking managers. Also, the use of intermediaries and complicated corporate structures to obscure bribes. Multiple cases revealed the
involvement of subsidiaries, third-party vendors, or shell companies that processed payments disguised as legitimate transaction. Reported
bribes amounted to about US$12.6 million, with sanctions exceeding US$1.1 billion. Government officials, regulatory authorities, and
healthcare providers were bribed through cash, gifts, luxury travel, and fraudulent research to gain market access, increase sales, or influence
prescribing. These findings underscore the systemic nature of bribery in the pharmaceutical sector and call for stronger oversight and
accountability to protect public trust and equitable medicine access.
Keywords: Bribery; Pharmaceutical corruption; Organisation for Economic Co-operation and Development; Global health governance;
Anti-corruption

Independent Articles Bribery and the Global Pharmaceutical Industry: An Exploration of Patterns and Penalties in the Organisation for Economic Cooperation and Development Reports Jillian Kohler1, Anaam Khan1, and Andrea Bowra2 1Leslie Dan Faculty of Pharmacy, University of Toronto, Canada and 2Dalla Lana School of Public Health, University of Toronto, Canada Abstract Bribery by the pharmaceutical industry is one common manifestation of corruption that can be found in a pharmaceutical system. This study analyzes patterns of bribery in the global pharmaceutical industry through a systematic review of Organisation for Economic Co-operation and Development (OECD) Working Group on Bribery Phase Reports published between 1999 and February 2025. These reports document investigations and enforcement actions related to bribery across jurisdictions. An inductive thematic analysis was used to identify key patterns in cases implicating pharmaceutical firms. We found patterns across many of the cases we studied. For example, bribery was often approved by high-ranking managers. Also, the use of intermediaries and complicated corporate structures to obscure bribes. Multiple cases revealed the involvement of subsidiaries, third-party vendors, or shell companies that processed payments disguised as legitimate transaction. Reported bribes amounted to about US$12.6 million, with sanctions exceeding US$1.1 billion. Government officials, regulatory authorities, and healthcare providers were bribed through cash, gifts, luxury travel, and fraudulent research to gain market access, increase sales, or influence prescribing. These findings underscore the systemic nature of bribery in the pharmaceutical sector and call for stronger oversight and accountability to protect public trust and equitable medicine access. Keywords: Bribery; Pharmaceutical corruption; Organisation for Economic Co-operation and Development; Global health governance; Anti-corruption

New open access on FirstView: "Bribery and the Global Pharmaceutical Industry: An Exploration of Patterns and Penalties in the Organisation for Economic Cooperation and Development Reports" by Jillian Kohler, Anaam Khan, and Andrea Bowra. #bribery #corruption

www.cambridge.org/core/journal...

11.02.2026 14:41 👍 1 🔁 3 💬 0 📌 0
Columns: Currents in Contemporary Bioethics
Remembering Dr. Kenneth C. Edelin
Carmel Shachar1 , Meg Lanthier1, and Eli Adashi2
1Harvard Law School, Harvard University, United States and 2Brown University Warren Alpert Medical School, United States
Abstract
After performing an abortion in 1973, Dr. Kenneth Edelin was indicted and convicted of manslaughter. Dr. Edelin’s conviction was reversed 50
years ago. However, the conflict between the medical and legal systems, the use of abortion prosecution to control patients and providers, and
the framing of a fetus as a person feel just as relevant to today’s abortion landscape.
Keywords: abortion; medical-legal conflicts; reproductive ethics; law

Columns: Currents in Contemporary Bioethics Remembering Dr. Kenneth C. Edelin Carmel Shachar1 , Meg Lanthier1, and Eli Adashi2 1Harvard Law School, Harvard University, United States and 2Brown University Warren Alpert Medical School, United States Abstract After performing an abortion in 1973, Dr. Kenneth Edelin was indicted and convicted of manslaughter. Dr. Edelin’s conviction was reversed 50 years ago. However, the conflict between the medical and legal systems, the use of abortion prosecution to control patients and providers, and the framing of a fetus as a person feel just as relevant to today’s abortion landscape. Keywords: abortion; medical-legal conflicts; reproductive ethics; law

New on FirstView: Shortly after Roe v. Wade, Dr. Kenneth C. Edelin was convicted of manslaughter in Massachusetts for providing abortion care. The case has lessons for today's post-Dobbs landscape. By @cshachar.bsky.social, Meg Lanthier, and Eli Adashi. #Abortion

www.cambridge.org/core/journal...

10.02.2026 14:26 👍 2 🔁 0 💬 0 📌 0

Thanks for including us on this great list of journals!

06.02.2026 18:44 👍 1 🔁 0 💬 0 📌 0
Post image

JLME's Winter issue covers a wide array of topics, from advance directives to oncofertility to medical-legal partnerships and more. Many of the articles are open access. Read it today at:
www.cambridge.org/core/journal...

05.02.2026 14:17 👍 1 🔁 3 💬 0 📌 0
Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming “Normal” | Journal of Law, Medicine & Ethics | Cambridge Core Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming “Normal”

New on FirstView: "Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming'Normal'” by Stephanie Solomon Cargill. Many thanks to @nadagligorov.bsky.social for assistance. #GeneTherapy
www.cambridge.org/core/journal...
#GeneTherapy

05.02.2026 15:18 👍 1 🔁 3 💬 1 📌 0

Stephanie Solomon Cargill was a valued member of the JLME Editorial Board. We are very glad to be able to publish this article posthumously.

05.02.2026 15:46 👍 1 🔁 0 💬 0 📌 0
Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming “Normal” | Journal of Law, Medicine & Ethics | Cambridge Core Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming “Normal”

New on FirstView: "Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming'Normal'” by Stephanie Solomon Cargill. Many thanks to @nadagligorov.bsky.social for assistance. #GeneTherapy
www.cambridge.org/core/journal...
#GeneTherapy

05.02.2026 15:18 👍 1 🔁 3 💬 1 📌 0
Post image

JLME's Winter issue covers a wide array of topics, from advance directives to oncofertility to medical-legal partnerships and more. Many of the articles are open access. Read it today at:
www.cambridge.org/core/journal...

05.02.2026 14:17 👍 1 🔁 3 💬 0 📌 0

The past year has shaken the foundations of U.S. leadership in global health governance amid:
* attacks on public health science,
* abandonment of U.S. foreign assistance &
* threats to global health governance.
The global health landscape is rapidly shifting — to the exclusion of the United States.

27.01.2026 21:47 👍 5 🔁 1 💬 1 📌 0
Post image

New Global Health Law column on FirstView: "US Global Health Leadership: The First Year of the Second Trump Administration" by Lawrence O. Gostin, @alexandrafinch.bsky.social , and @benjaminmasonmeier.bsky.social .
#Trump #TrumpAdministration #RFK #HHS #WHO
www.cambridge.org/core/journal...

27.01.2026 19:11 👍 1 🔁 1 💬 0 📌 1
Independent Articles
Objective Standards of Medical Judgment: A Myth of (Texas) Abortion
Law
Abraham Graber1 , Mack Peterson2, and Ethan Detrick2
1Biomedical Education and Anatomy, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, United States and 2The Ohio State University,
United States
Abstract
Post-Dobbs v. Jackson, abortion regulation is left entirely to the states. Laws that restrict access to abortion generally allow for exceptions when
determined necessary for the life or safety of the pregnant patient. Some states, e.g., Ohio, use a “subjective” legal standard when determining
whether an abortion is medically necessary. Other states, e.g., Texas, rely on an “objective” legal standard, whereby the necessity of an abortion
is not determined by any particular physician’s judgments, but rather by the judgment of a hypothetical “reasonable physician.” Though
objective legal standards are widespread in American jurisprudence, they are a poor fit for clinical judgments about the medical necessity of
abortion. Onthe contemporary model of clinical decision-making, medical judgment is irremediably subjective. In addition to being responsive
to patient values and medical evidence, medical judgment is, and should be, informed by physician values. Because Texas abortion regulations
rely on an objective standard of judgment that fails to correspond to a medically meaningful category, they fail to provide adequate guidance to
physicians regarding the circumstances under which abortion is legally protected.
Keywords: Abortion; Dobbs v. Jackson; Human Life Protection Act; Objective Standards; Subjective Standards

Independent Articles Objective Standards of Medical Judgment: A Myth of (Texas) Abortion Law Abraham Graber1 , Mack Peterson2, and Ethan Detrick2 1Biomedical Education and Anatomy, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, United States and 2The Ohio State University, United States Abstract Post-Dobbs v. Jackson, abortion regulation is left entirely to the states. Laws that restrict access to abortion generally allow for exceptions when determined necessary for the life or safety of the pregnant patient. Some states, e.g., Ohio, use a “subjective” legal standard when determining whether an abortion is medically necessary. Other states, e.g., Texas, rely on an “objective” legal standard, whereby the necessity of an abortion is not determined by any particular physician’s judgments, but rather by the judgment of a hypothetical “reasonable physician.” Though objective legal standards are widespread in American jurisprudence, they are a poor fit for clinical judgments about the medical necessity of abortion. Onthe contemporary model of clinical decision-making, medical judgment is irremediably subjective. In addition to being responsive to patient values and medical evidence, medical judgment is, and should be, informed by physician values. Because Texas abortion regulations rely on an objective standard of judgment that fails to correspond to a medically meaningful category, they fail to provide adequate guidance to physicians regarding the circumstances under which abortion is legally protected. Keywords: Abortion; Dobbs v. Jackson; Human Life Protection Act; Objective Standards; Subjective Standards

New open-access on FirstView: "Objective Standards of Medical Judgment: A Myth of (Texas) Abortion Law" by Abraham Graber of
@osuwexmed.bsky.social, Mack Peterson, and Ethan Detrick. #Abortion #Dobbs #HumanLifeProtectionAct

www.cambridge.org/core/journal...

26.01.2026 16:52 👍 0 🔁 1 💬 0 📌 0
Independent Articles
Objective Standards of Medical Judgment: A Myth of (Texas) Abortion
Law
Abraham Graber1 , Mack Peterson2, and Ethan Detrick2
1Biomedical Education and Anatomy, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, United States and 2The Ohio State University,
United States
Abstract
Post-Dobbs v. Jackson, abortion regulation is left entirely to the states. Laws that restrict access to abortion generally allow for exceptions when
determined necessary for the life or safety of the pregnant patient. Some states, e.g., Ohio, use a “subjective” legal standard when determining
whether an abortion is medically necessary. Other states, e.g., Texas, rely on an “objective” legal standard, whereby the necessity of an abortion
is not determined by any particular physician’s judgments, but rather by the judgment of a hypothetical “reasonable physician.” Though
objective legal standards are widespread in American jurisprudence, they are a poor fit for clinical judgments about the medical necessity of
abortion. Onthe contemporary model of clinical decision-making, medical judgment is irremediably subjective. In addition to being responsive
to patient values and medical evidence, medical judgment is, and should be, informed by physician values. Because Texas abortion regulations
rely on an objective standard of judgment that fails to correspond to a medically meaningful category, they fail to provide adequate guidance to
physicians regarding the circumstances under which abortion is legally protected.
Keywords: Abortion; Dobbs v. Jackson; Human Life Protection Act; Objective Standards; Subjective Standards

Independent Articles Objective Standards of Medical Judgment: A Myth of (Texas) Abortion Law Abraham Graber1 , Mack Peterson2, and Ethan Detrick2 1Biomedical Education and Anatomy, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, United States and 2The Ohio State University, United States Abstract Post-Dobbs v. Jackson, abortion regulation is left entirely to the states. Laws that restrict access to abortion generally allow for exceptions when determined necessary for the life or safety of the pregnant patient. Some states, e.g., Ohio, use a “subjective” legal standard when determining whether an abortion is medically necessary. Other states, e.g., Texas, rely on an “objective” legal standard, whereby the necessity of an abortion is not determined by any particular physician’s judgments, but rather by the judgment of a hypothetical “reasonable physician.” Though objective legal standards are widespread in American jurisprudence, they are a poor fit for clinical judgments about the medical necessity of abortion. Onthe contemporary model of clinical decision-making, medical judgment is irremediably subjective. In addition to being responsive to patient values and medical evidence, medical judgment is, and should be, informed by physician values. Because Texas abortion regulations rely on an objective standard of judgment that fails to correspond to a medically meaningful category, they fail to provide adequate guidance to physicians regarding the circumstances under which abortion is legally protected. Keywords: Abortion; Dobbs v. Jackson; Human Life Protection Act; Objective Standards; Subjective Standards

New open-access on FirstView: "Objective Standards of Medical Judgment: A Myth of (Texas) Abortion Law" by Abraham Graber of
@osuwexmed.bsky.social, Mack Peterson, and Ethan Detrick. #Abortion #Dobbs #HumanLifeProtectionAct

www.cambridge.org/core/journal...

26.01.2026 16:52 👍 0 🔁 1 💬 0 📌 0
Independent Articles
Regulating Medical Devices: The Values and Politics of the US FDA
Review Process
Melanie Jeske1 and Kelly Joyce2
1Center for Medical Ethics and Health Policy, Baylor College of Medicine, United States and 2College of Arts and Sciences, University of North Carolina at Greensboro,
Greensboro, United States
Abstract
Since the mid-20th century, medical devices have proliferated in clinical care, operating rooms, and in everyday life via home health and
wearable technologies. Medical devices include a broad range of technologies such as imaging devices, genomic assays, surgical implants,
assistive devices, and health monitors. Unlike pharmaceuticals, food, and cosmetics, the United States Food and Drug Administration (FDA)
did not prioritize medical device regulation in the early 1900s; devices only became a site of concern post-World War II as more complex and
invasive technologies were developed and used in health care. Drawing on analysis of FDA regulations, government documents, historical
media coverage, and FDA oral histories, this article traces the evolution of medical device regulation, historicizing persistent debates that
position technological innovation and regulation in tension with one another. We demonstrate how limited legal authority prior to 1976
positioned FDA as lagging behind the proliferation of medical devices, which continues to haunt device regulation today. We then analyze the
values embedded in device risk classifications and regulatory pathways, considering the consequences for the public’s safety and trust.
Keywords: regulation; FDA; medical technology; innovation; patient safety

Independent Articles Regulating Medical Devices: The Values and Politics of the US FDA Review Process Melanie Jeske1 and Kelly Joyce2 1Center for Medical Ethics and Health Policy, Baylor College of Medicine, United States and 2College of Arts and Sciences, University of North Carolina at Greensboro, Greensboro, United States Abstract Since the mid-20th century, medical devices have proliferated in clinical care, operating rooms, and in everyday life via home health and wearable technologies. Medical devices include a broad range of technologies such as imaging devices, genomic assays, surgical implants, assistive devices, and health monitors. Unlike pharmaceuticals, food, and cosmetics, the United States Food and Drug Administration (FDA) did not prioritize medical device regulation in the early 1900s; devices only became a site of concern post-World War II as more complex and invasive technologies were developed and used in health care. Drawing on analysis of FDA regulations, government documents, historical media coverage, and FDA oral histories, this article traces the evolution of medical device regulation, historicizing persistent debates that position technological innovation and regulation in tension with one another. We demonstrate how limited legal authority prior to 1976 positioned FDA as lagging behind the proliferation of medical devices, which continues to haunt device regulation today. We then analyze the values embedded in device risk classifications and regulatory pathways, considering the consequences for the public’s safety and trust. Keywords: regulation; FDA; medical technology; innovation; patient safety

New on FirstView: "Regulating Medical Devices: The Values and Politics of the US FDA Review Process" by Melanie Jeske of @bcmhouston.bsky.social and Kelly Joyce investigates how problems with medical device regulation persist today. #FDA #MedicalDevices

www.cambridge.org/core/journal...

23.01.2026 15:22 👍 3 🔁 5 💬 0 📌 0
Independent Articles
Regulating Medical Devices: The Values and Politics of the US FDA
Review Process
Melanie Jeske1 and Kelly Joyce2
1Center for Medical Ethics and Health Policy, Baylor College of Medicine, United States and 2College of Arts and Sciences, University of North Carolina at Greensboro,
Greensboro, United States
Abstract
Since the mid-20th century, medical devices have proliferated in clinical care, operating rooms, and in everyday life via home health and
wearable technologies. Medical devices include a broad range of technologies such as imaging devices, genomic assays, surgical implants,
assistive devices, and health monitors. Unlike pharmaceuticals, food, and cosmetics, the United States Food and Drug Administration (FDA)
did not prioritize medical device regulation in the early 1900s; devices only became a site of concern post-World War II as more complex and
invasive technologies were developed and used in health care. Drawing on analysis of FDA regulations, government documents, historical
media coverage, and FDA oral histories, this article traces the evolution of medical device regulation, historicizing persistent debates that
position technological innovation and regulation in tension with one another. We demonstrate how limited legal authority prior to 1976
positioned FDA as lagging behind the proliferation of medical devices, which continues to haunt device regulation today. We then analyze the
values embedded in device risk classifications and regulatory pathways, considering the consequences for the public’s safety and trust.
Keywords: regulation; FDA; medical technology; innovation; patient safety

Independent Articles Regulating Medical Devices: The Values and Politics of the US FDA Review Process Melanie Jeske1 and Kelly Joyce2 1Center for Medical Ethics and Health Policy, Baylor College of Medicine, United States and 2College of Arts and Sciences, University of North Carolina at Greensboro, Greensboro, United States Abstract Since the mid-20th century, medical devices have proliferated in clinical care, operating rooms, and in everyday life via home health and wearable technologies. Medical devices include a broad range of technologies such as imaging devices, genomic assays, surgical implants, assistive devices, and health monitors. Unlike pharmaceuticals, food, and cosmetics, the United States Food and Drug Administration (FDA) did not prioritize medical device regulation in the early 1900s; devices only became a site of concern post-World War II as more complex and invasive technologies were developed and used in health care. Drawing on analysis of FDA regulations, government documents, historical media coverage, and FDA oral histories, this article traces the evolution of medical device regulation, historicizing persistent debates that position technological innovation and regulation in tension with one another. We demonstrate how limited legal authority prior to 1976 positioned FDA as lagging behind the proliferation of medical devices, which continues to haunt device regulation today. We then analyze the values embedded in device risk classifications and regulatory pathways, considering the consequences for the public’s safety and trust. Keywords: regulation; FDA; medical technology; innovation; patient safety

New on FirstView: "Regulating Medical Devices: The Values and Politics of the US FDA Review Process" by Melanie Jeske of @bcmhouston.bsky.social and Kelly Joyce investigates how problems with medical device regulation persist today. #FDA #MedicalDevices

www.cambridge.org/core/journal...

23.01.2026 15:22 👍 3 🔁 5 💬 0 📌 0
Post image

Join us for the next Future of Health Care Series event: After Dobbs: How the Supreme Court Ended Roe but Not Abortion.

This panel examines how abortion access has evolved in the wake of Dobbs.

📅 Fri, Feb. 6 | 12:00–1:30 PM ET | Virtual via Zoom

🔗 Free registration: tinyurl.com/3d72p84a

22.01.2026 15:18 👍 2 🔁 3 💬 1 📌 2
Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It’s Worth a Shot | Journal of Law, Medicine & Ethics | Cambridge Core Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It’s Worth a Shot - Volume 52 Issue 1

In 2024, Margaret Irwin, Derek R. Soled, and Christy L. Cummings proposed lowering the age of vaccine consent to 12 years for CDC-approved vaccinations.
#VaccineConsent
www.cambridge.org/core/journal...

21.01.2026 15:05 👍 0 🔁 0 💬 0 📌 0
Shaming Vaccine Refusal | Journal of Law, Medicine & Ethics | Cambridge Core Shaming Vaccine Refusal - Volume 45 Issue 4

In 2021, @manofsilver.bsky.social and @lindsaywiley.bsky.social asked whether vaccine shaming was effective or ethically justifiable:
#vaccine #VaccineShaming
www.cambridge.org/core/journal...

21.01.2026 14:59 👍 0 🔁 0 💬 1 📌 0
The Pediatrician's Dilemma: Refusing the Refusers of Infant Vaccines | Journal of Law, Medicine & Ethics | Cambridge Core The Pediatrician's Dilemma: Refusing the Refusers of Infant Vaccines - Volume 43 Issue 3

From the archives: Stan L. Block discusses the ethical dilemmas for and financial costs to pediatricians that refuse patients whose parents refuse #vaccines :
www.cambridge.org/core/journal...

21.01.2026 14:54 👍 0 🔁 0 💬 1 📌 0
Columns: Currents in Contemporary Bioethics
Bioethics in the Courtroom: Sketching Medicine with Integrity
Katrina A. Bramstedt1,2,3
1F. Hoffmann-La Roche AG, Switzerland; 2Queensland University of Technology, School of Medicine, Australia and 3International Hellenic University, Greece
Abstract
Just as court reporters are the“
ears
” of the courtroom, court artists are the“
eyes” of the courtroom. The adage“a picture is worth a thousand
words” shows the importance of the integrity of that image. Because the artist’s sketch can convey information pertaining to the health of a
defendant/plaintiff/witness, misrepresentation by the artist must be avoided so as to foster honest journalism. From a bioethics perspective,
courtroom art should align to the live, physical (visible) presentation, even if one or more elements of the physical presentation has been
fabricated. Similarly, invisible illnesses and symptoms should not be added to courtroom sketches. The court artist has a duty of objectivity and
clinical honesty in their artwork. This fosters justice and journalistic integrity.
Keywords: medical humanities; bioethics; journalism; jurisprudence; signs and symptoms; art

Columns: Currents in Contemporary Bioethics Bioethics in the Courtroom: Sketching Medicine with Integrity Katrina A. Bramstedt1,2,3 1F. Hoffmann-La Roche AG, Switzerland; 2Queensland University of Technology, School of Medicine, Australia and 3International Hellenic University, Greece Abstract Just as court reporters are the“ ears ” of the courtroom, court artists are the“ eyes” of the courtroom. The adage“a picture is worth a thousand words” shows the importance of the integrity of that image. Because the artist’s sketch can convey information pertaining to the health of a defendant/plaintiff/witness, misrepresentation by the artist must be avoided so as to foster honest journalism. From a bioethics perspective, courtroom art should align to the live, physical (visible) presentation, even if one or more elements of the physical presentation has been fabricated. Similarly, invisible illnesses and symptoms should not be added to courtroom sketches. The court artist has a duty of objectivity and clinical honesty in their artwork. This fosters justice and journalistic integrity. Keywords: medical humanities; bioethics; journalism; jurisprudence; signs and symptoms; art

New on FirstView: "Bioethics in the Courtroom: Sketching Medicine with Integrity" by Katrina A. Bramstedt discusses how the portrayal of the medical condition of a witness, plaintiff, or defendant can affect the public's perception of them. #bioethics #journalism
www.cambridge.org/core/journal...

13.01.2026 15:11 👍 1 🔁 1 💬 0 📌 0
Launch: ‘Public Health, Markets, and Law’, a Symposium in the Journal of Law, Medicine, and Ethics – EU Health Governance Network

Our first webinar of 2026 is a launch of the @jlme-journal.bsky.social "Public Health, Markets, and Law" Symposium

We're delighted to welcome the guest editors & the contributors to present overviews of their papers

Join us on Tuesday 24 February at 15:00 GMT!

euhealthgov.org/launch-publi...

12.01.2026 10:48 👍 3 🔁 2 💬 0 📌 0
Columns: Teaching Health Law
Using Tiny Research Assignments to Support Active Learning
Nadia Sawicki
Loyola University Chicago Law School, United States
Abstract
This article argues that weekly“tiny research assignments” in introductory health law courses promote active learning and deepen student
engagement. These focused exercises also build foundational research and communication skills by replacing passive lecture with concise,
student-driven investigation tied to each week’s topic.
Keywords: Pedagogy; legal education; active learning; research assignments; student engagement

Columns: Teaching Health Law Using Tiny Research Assignments to Support Active Learning Nadia Sawicki Loyola University Chicago Law School, United States Abstract This article argues that weekly“tiny research assignments” in introductory health law courses promote active learning and deepen student engagement. These focused exercises also build foundational research and communication skills by replacing passive lecture with concise, student-driven investigation tied to each week’s topic. Keywords: Pedagogy; legal education; active learning; research assignments; student engagement

New open-access on FirstView: "Using Tiny Research Assignments to Support Active Learning" by @nnsawicki.bsky.social. This article gives actionable insights and exercises that are immediately useful to anyone teaching health law — and other fields, too. #pedagogy
www.cambridge.org/core/journal...

12.01.2026 15:15 👍 4 🔁 4 💬 0 📌 0

Intriguing quote regarding the obstacles: "...in North America, the market is the primary 'arbiter of societal functioning.' People would have to interact as a community rather than a market to undertake 'a collective obligation of concern and support, for each other’s health.'”

19.12.2025 16:32 👍 3 🔁 1 💬 0 📌 0
Social Determinants of Health Revisited: Detouring Around the
Weberian Bureaucracy
Ming-Jui Yeh
Institute of Health Policy and Management, National Taiwan University, Taiwan
Abstract
The knowledge of the Social Determinants of Health (SDH) approach implies Health in All Policies and thorough cultural and social
transformations, as well as whole-of-government, whole-of-society policies and governance to address health inequities. Nonetheless, this
article argues that in the currently dominant rational decision-making model in health policymaking, these policy implications from the
knowledge of the SDH approach would lead to an intrinsic contradiction with the logic of modern bureaucracy based on the legal authority as
suggested by Max Weber. Using two examples of social determinants of health— universal health coverage and housing issues— this article
demonstrates the potential of the polis model proposed by Deborah Stone to take advantage of the knowledge of the SDH approach to pursue
structural policy interventions.
Keywords: Social determinants of health; Public health policy; Epidemiology; Weber

Social Determinants of Health Revisited: Detouring Around the Weberian Bureaucracy Ming-Jui Yeh Institute of Health Policy and Management, National Taiwan University, Taiwan Abstract The knowledge of the Social Determinants of Health (SDH) approach implies Health in All Policies and thorough cultural and social transformations, as well as whole-of-government, whole-of-society policies and governance to address health inequities. Nonetheless, this article argues that in the currently dominant rational decision-making model in health policymaking, these policy implications from the knowledge of the SDH approach would lead to an intrinsic contradiction with the logic of modern bureaucracy based on the legal authority as suggested by Max Weber. Using two examples of social determinants of health— universal health coverage and housing issues— this article demonstrates the potential of the polis model proposed by Deborah Stone to take advantage of the knowledge of the SDH approach to pursue structural policy interventions. Keywords: Social determinants of health; Public health policy; Epidemiology; Weber

New open-access on FirstView: "Social Determinants of Health Revisited: Detouring Around the Weberian Bureaucracy," by Min-Jul Yeh. The article details the structural issues in resolving social determinants of health, and suggests ways to circumvent them.
www.cambridge.org/core/journal...

19.12.2025 16:27 👍 3 🔁 0 💬 0 📌 1