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Coming together:… image

Coming together: Forging new paths to action for the Sustainable Development Goals


17 Rooms, featuring Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
Brookings

A partnership between the Center for Sustainable Development at Brookings and The Rockefeller Foundation, 17 Rooms is an experimental method for advancing the economic, social, and environmental priorities embedded in the…

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Meaning in Lives Nearing Their End


Francis Kamm (Former Senior Fellow)
Royal Institute of Philosophy Supplements

In this paper, I consider the idea of meaning in life as I believe it has arisen in some discussions of ageing and death. I critically examine and compare the…

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Responsible use of polygenic risk scores in the clinic: potential benefits, risks and gaps


Polygenic Risk Score Task Force of the International Common Disease Alliance, including Michelle N. Meyer (Former Academic Fellow)
Nature Medicine

Polygenic risk scores (PRSs) aggregate the many small effects of alleles across the human genome to estimate the risk of a disease or disease-related trait for an individual. The potential…

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Read now! International Pandemic Lawmaking: Conceptual and Practical Issues Report


Edited by Alicia Ely Yamin, Joelle Grogan, and Pedro Villarreal

Between 20 September and 4 November 2021, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Middlesex University London, and the Max Planck Institute of Comparative Public Law…

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Simplify drug labelling to show benefits clearly


Jonathan J. Darrow (Former Student Fellow)
Nature

Aducanumab, an Alzheimer’s disease treatment, was approved by the US Food and Drug Administration (FDA) in June this year despite a lack of robust evidence that it actually…

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From health to political economy: How we ‘know what we know’ and why intersecting matters now


Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
INTERSECTING: Sustainable Responses to The COVID-19 Pandemic

That our world is growingly complex is hardly a radical revelation. The challenge is to act accordingly. To widen our knowledge, we specialize and consequently isolate ourselves in various silos.…

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Human Rights Obligations of States to not impede the Proposed COVID-19 TRIPS Waive


International Commission of Jurists Expert Legal Opinion co-signed by Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
International Commission of Jurists

This opinion applies to the full range of diagnostics, medications, vaccines, therapeutics and other relevant health products required for the containment, prevention and mitigation of COVID-19. In short, it sets…

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Understanding The New Drug Price Reform Deal


Rachel E. Sachs (Former Academic Fellow)
HealthAffairs

Yesterday, the text of the Democratic deal on prescription drug pricing reform was released. These drug pricing reforms are intended to move forward as part of a broader reconciliation package…

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Editorial: Can a Pandemic Law-Making Exercise Promote Global Health Justice?


Alicia Ely Yamin (Senior Fellow in Global Health and Rights), Joelle Grogan, and Pedro A. Villarreal
Verfassungsblog

Amid the unfolding "moral catastrophe" of COVID-19, and across the entries in this symposium, we see a clamor for any pandemic law-making exercise to promote more justice in…

Problematic Interactions Between AI and Health Privacy


Nicholson Price (Former Academic Fellow)
Utah Law Review

The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens…

Diagnóstico de la participación de las mujeres en el sistema de justicia argentino


María Natalia Echegoyemberry (Affiliated Researcher)
La participación de las mujeres en los sistemas de justicia en América Latina

En Argentina, la Constitución Nacional recoge la cláusula general de igualdad, pero no incorpora un principio de representación paritaria. Sin embargo, a partir de…

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Integrating Supported Decision-Making into the Clinical Research Process


Barbara E. Bierer, Ari Ne’eman, Willyanne DeCormier Plosky, David H. Strauss, Benjamin C. Silverman, and Michael Ashley Stein (Affiliated Faculty)
The American Journal of Bioethics

Peterson, Karlawish, and Largent’s (2021) “Supported Decision Making with People at the Margins of Autonomy” brings welcome attention to the rights of people with cognitive impairment and…

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Cross-Border Transfers of Personal Data after Schrems II: Supplementary Measures and New Standard Contractual Clauses (SCCs)


Marcelo Corrales Compagnucci, Mateo Aboy, and Timo Minssen (Former Visiting Scholar)
SSRN

This article analyses the legal challenges of international data transfers resulting from the recent Court of Justice of the European Union (CJEU) decision in Case C-311/18 Data Protection Commissioner v…

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FDA Drug Approval and the Ethics of Desperation


Emily A. Largent, Andrew Peterson, and Holly Fernandez Lynch (Former Executive Director)
JAMA Internal Medicine

In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear…

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Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use


Andrea Seykora, Carl Coleman, Stephen J. Rosenfeld, Barbara E. Bierer, and Holly Fernandez Lynch (Former Executive Director)
Ethics & Human Research

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect…

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German Pharmaceutical Pricing: Lessons for the United States


Marc A. Rodwin and Sara Gerke (Former Research Fellow in Medicine, Artificial Intelligence, and Law)
International Journal of Health Services

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell…

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When Should Neuroendovascular Care for Patients With Acute Stroke Be Palliative?


Michael J. Young (Former Student Fellow), Robert W. Regenhardt, Leonard L. Sokol, and Thabele M. Leslie-Mazwi
AMA Journal of Ethics

Noncurative surgeries intended to relieve suffering during serious illness or near end of life have been analyzed across palliative settings. Yet sparse guidance is available to inform clinical management decisions…

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Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?


Holly Fernandez Lynch (Former Executive Director) et al.
American Journal of Bioethics

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s…

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Telehealth to Address Health Disparities: Potential, Pitfalls, and Paths Ahead


David A. Simon (Research Fellow, Digital Home Health) and Carmel Shachar (Executive Director)
Journal of Law, Medicine and Ethics

Telehealth has the potential to address health disparities, but not without deliberate choices about how to implement it. To support vulnerable patients, health policy leaders must pursue creative solutions such…

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Pharmaceutical Companies, Human Rights, and the Alien Tort Statute


I. Glenn Cohen (Faculty Director), Tyler Giannini, and Eli Y. Adashi
Journal of Law, Medicine & Ethics

On January 3, 2019, U.S. District Judge Theodore D. Chuang of the U.S. District Court of the District of Maryland took a crucial first step in redressing one of the…