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“I’d feel like… image

“I’d feel like someone was watchin’ me… watching for a good reason”: perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with


Georgia R. Goodman et al., including I. Glenn Cohen (Faculty Director)
AIDS and Behavior

Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM)…

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Health Care Fraud: The Leading Violation of the False Claims Act


Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
The American Journal of Medicine

It is a sign of the times when the lion's share of the schemes intent on defrauding the federal government are in the health care arena. Data reported by…

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Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel


Sanket S. Dhruva, Jonathan J. Darrow (Former Student Fellow), Aaron S. Kesselheim, and Rita F. Redberg
Clinical Pharmacology and Therapeutics

Prescription drugs and medical devices are increasingly coming to market through expedited US Food and Drug Administration (FDA) pathways that require only limited evidence of safety and efficacy, such as…

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AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care


Ariel Dora Stern, Avi Goldfarb, Timo Minssen, and W. Nicholson Price II (Former Academic Fellow)
NEJM Catalyst

Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors…

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Ethics and the 2018 Practice Guideline on Disorders of Consciousness


Michael J. Young (Former Student Fellow), Yelena G. Bodien, and Brian L. Edlow
Neurology

The 2018 practice guideline on disorders of consciousness marks an important turning point in the care of patients with severe brain injury. As clinicians and health systems implement the guideline in…

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Step Therapy’s Balancing Act — Protecting Patients while Addressing High Drug Prices


Rachel E. Sachs (Former Academic Fellow) and Michael Anne Kyle
New England Journal of Medicine

The debate regarding step therapy reflects a tension between two important policy goals: safeguarding patients’ access to high-quality care and constraining spending on prescription drugs, including by limiting the…

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Patient Assistance Programs and the Anti-Kickback Statute: Charting a Pathway Forward


Michael S. Sinha, Aaron S. Kesselheim, and Christopher T. Robertson (Former Academic Fellow)
JAMA

In the US health care system, as millions of patients remain uninsured and many more experience substantial cost exposures through deductibles, coinsurance, and co-payments,1 some have turned to patient assistance…

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When Desperate Patients Go to Court for Unproven Treatments — The Battle for Hospital Independence


Christopher Robertson (Former Academic Fellow) and Margaret Houtz
New England Journal of Medicine

During the Covid-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. These lawsuits have called into question the judiciary’s role in medical…

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Distributed Governance of Medical AI


W. Nicholson Price II (Former Academic Fellow)
SMU Science and Technology Law Review

Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human…

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SARS-CoV-2 Laboratory-Developed Tests: Integrity Restored


Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
JAMA

On November 15, 2021, the US Department of Health and Human Services (HHS) rescinded a Trump-era policy that had directed the US Food and Drug Administration (FDA) to discontinue the premarket reviews…

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Mitigating Racial Bias in Machine Learning


by Kristin M. Kostick-Quenet, I. Glenn Cohen (Faculty Director), Sara Gerke, et al.
Journal of Law, Medicine and Ethics

When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or…

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Introduction: Health Law and Anti-Racism: Reckoning and Response


Michele Goodwin and Holly Fernandez Lynch (Former Executive Director)
Journal of Law, Medicine and Ethics

Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with…

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Reflections on Paul Farmer’s legacy: a clarion call for transformative human rights praxis in global health


Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
OpenGlobalRights

Paul Farmer’s far-too-early passing on February 21, 2022 is an incalculable loss to those of us who knew and loved him, to students and patients around the globe, to the…

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How do we encourage innovation on “long COVID”?


Jacob S. Sherkow (Former Fellow), Lisa Larrimore Ouellette, Nicholson Price (Former Academic Fellow), and Rachel Sachs (Former Academic Fellow)
Written Description

Since the pandemic began, numerous recovered COVID-19 patients have reported having “long COVID”: COVID-19 symptoms persisting well beyond the underlying viral infection period. Whether such a condition is…

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Travel restrictions and variants of concern: global health laws need to reflect evidence


Benjamin Mason Meier et al., including Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
The Bulletin of the World Health Organization

As the coronavirus disease 2019 (COVID-19) spread in the early days of the pandemic, governments neglected World Health Organization (WHO) guidance and imposed travel restrictions. These public health measures employed varied…

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Artificial Intelligence in Healthcare


Nakul Aggarwal, Michael E. Matheny, Carmel Shachar (Executive Director), Samantha X.Y. Wang, and Sonoo Thadaney-Israni
The Oxford Handbook of AI Governance

Artificial intelligence (AI) is poised to significantly impact healthcare systems, including clinical diagnosis, healthcare administration and delivery, and public health infrastructures. In the context of the Quintuple Aim of healthcare …

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Institutional Review Board Use of Outside Experts: What Do We Know?


Kimberley Serpico, Vasiliki Rahimzadeh, Emily E. Anderson, Luke Gelinas, and Holly Fernandez Lynch (Former Executive Director)
Ethics and Human Research

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There…

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Transparency and the Doctor–Patient Relationship — Rethinking Conflict-of-Interest Disclosures


Eli Y. Adashi, I. Glenn Cohen (Faculty Director), and Jacob T. Elberg
The New England Journal of Medicine

To reduce the harm associated with improper financial relationships between manufacturers and physicians, practitioners could be required to disclose such relationships directly to patients.

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On Sea Monsters and Sandcastles: Revisiting International Legal Frameworks regarding Public Health and Human Rights in Global Health Emergencies


Alicia Ely Yamin (Senior Fellow in Global Health and Rights), Stefania Negri, and Roojin Habibi
Yearbook of International Disaster Law

As a new coronavirus, SARS-CoV-2, swept across the globe with unprecedented speed in 2020, countries were faced with navigating between the proverbial Scylla and Charybdis. In a quickly evolving situation, with…

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Patents on Psychedelics: The Next Legal Battlefront of Drug Development


I. Glenn Cohen (Faculty Director) and Mason Marks (Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation)
Harvard Law Review

In the past two decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for…