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The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues


Jenna Becker, Sara Gerke, and I. Glenn Cohen
Handbook of Bioethical Decisions

Artificial Intelligence (AI), especially of the machine learning (ML) variety, is used by health care organizations to assist with a number of tasks, including diagnosing patients and optimizing operational workflows.…

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The New European Medical Device Regulation: Balancing Innovation and Patient Safety


Michael Bretthauer and Sara Gerke
Annals of Internal Medicine

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they…

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The proposed EU Directives for AI Liability Leave Worrying Gaps Likely to Impact Medical AI


Mindy Nunez Duffourc and Sara Gerke
Nature NPJ Digital Medicine

Two newly proposed Directives impact liability for artificial intelligence in the EU: a Product Liability Directive (PLD) and an AI Liability Directive (AILD). While these proposed Directives provide some uniform…

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Artificial intelligence tools in Clinical Neuroradiology: Essential Medico-Legal Aspects


Dennis M. Hedderich, Christian Weisstanner, Sofie Van Cauter, Christian Federau, Myriam Edjlali, Alexander Radbruch, Sara Gerke, et al.
Neuroradiology

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues…

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Ethical perspectives on Surgical Video Recording for Patients, Surgeons and Society: Systematic Review


Sara Gerke
British Journal of Surgery

For a surgical video to be a truly valuable resource, its potential benefits must be more fully weighed against its potential disadvantages, so that any derived instruments have a solid…

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Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients


Mindy Duffourc, Sara Gerke, et al.
JAMA

Generative artificial intelligence (AI) is a quickly emerging subfield of AI that can be trained with large data sets to create realistic images, videos, text, sound, 3-dimensional models, virtual environments,…

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Five Lessons for Advancing Maternal Health Rights in an Age of Neoliberal Globalization and Conservative Backlash


Alicia Ely Yamin
Health and Human Rights Journal

After considerable progress in recent decades, maternal mortality and morbidity (MMM) either stagnated or worsened in most regions of the globe between 2016 and 2020. The world should be outraged given that…

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When Misfortune Becomes Injustice: Evolving Human Rights Struggles for Health and Social Equality


Alicia Ely Yamin
Stanford University Press

When Misfortune Becomes Injustice surveys the progress and challenges in deploying human rights to advance health and social equality over recent decades. Alicia Ely Yamin weaves together theory and firsthand…

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Step by Step in Argentina: Putting Abortion Rights into Practice


Silvina Ramos, Brianna Keefe-Oates, Mariana Romero, Agustina Ramon Michel, Mercedes Krause, Caitlin Gerdts, and Alicia Ely Yamin
Dovepress

In December of 2020, the Argentine Congress legalized abortion through 14 weeks, vastly increasing access to abortion care in the country. The law’s passage followed years of advocacy for abortion…

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AI Chatbots, Health Privacy, and Challenges to HIPAA Compliance


Mason Marks and Claudia E. Haupt
JAMA

As health care becomes more expensive and difficult to access, people turn to websites and smartphone apps for medical advice. These resources increasingly feature artificial intelligence (AI)–powered chatbots…

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Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption


Carmel Shachar, Philip A. Gruppuso, and Eli Y. Adashi
JAMA

The last year witnessed several significant shortages of key medicines and other products for children, including children’s formulations of acetaminophen and ibuprofen as well as frontline antibiotics prescribed…

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Extending the US Food and Drug Administration’s Postmarket Authorities


Holly Fernandez Lynch, Rachel E. Sachs, and Sejin Lee
JAMA Health Forum

Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug’s benefit not only when it first enters the…

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Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness


Holly Fernandez Lynch, et al.
JAMA

Independent review and oversight have long been recognized as requirements for ethical research involving human participants, leading institutional review boards (IRBs) to become deeply entrenched in the research enterprise. Against…

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Assisted Reproduction Post-Dobbsthe Prospect of Legislative Protection


Eli Y. Adashi, Daniel P. O’Mahony, and I. Glenn Cohen
Fertility and Sterility Reports

Dobbs v. Jackson opened up the possibility of more state restrictions that may not only restrict abortion but also restrict assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF).…

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Hospital at Home Receives a New Lease on Life: A Promising if Uncertain Future


Eli Y. Adashi, Daniel P. O'Mahony, and I. Glenn Cohen
The American Journal of Medicine

Though destined to sunset on May 11, 2023 at the conclusion of the 40 months-long federal Public Health Emergency (PHE), the Acute Hospital Care at Home (AHCaH) program was recently extended through December 31, 2024…

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Patient-Assistance Programs, Kickbacks, and the Courts


Jacob T. Elberg, Eli Y. Adashi, and Glenn Cohen
New England Journal of Medicine

Pharmaceutical companies have sought to reduce cost sharing by means of patient-assistance programs. Some such programs have been under scrutiny because of questions about whether they violate federal law.

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Observational Studies Must be Reformed Before the Next Pandemic


Emily E. Ricotta, Annette Rid, Glenn Cohen, et al.
Nature Medicine

Observational studies provide crucial information early during epidemics and pandemics, but they often suffer from methodological shortcomings, which can be resolved.

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The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Model


Timo Minssen, Effa Vayena, and I. Glenn Cohen
JAMA

The introduction of artificial intelligence (AI) into medical devices, decision support, and clinical practice is not new, with a particular uptick in investment and deployment within the past decade. What…

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The New Threat to Abortion Access in the United States—The Comstock Act


I. Glenn Cohen, et al.
JAMA

In this Viewpoint we discuss an issue that is being litigated in several courts—the Comstock Act. This statute, named after US Postal Service agent and antivice crusader Anthony…

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The United Nations Convention on the Rights of Persons with Disabilities, Neuroscience, and Criminal Legal Capacity


Benjamin A. Barsky and Michael Ashley Stein
Journal of Law and the Biosciences

The United Nations Convention on the Rights of Persons with Disabilities requires states parties to ‘recognize that persons with disabilities enjoy legal capacity on an equal basis with others…