Resources: Affiliate Scholarship
Administration Finalizes Most-Favored Nation Drug Pricing Rule At The Last Minute
On Friday, the Trump Administration issued final versions of two drug pricing rules it had proposed years ago: the “most-favored-nations rule,” first proposed in October 2018 (summarized here), and…
What role is AI playing in the COVID-19 pandemic?
Complete author list: Nicholson Price (Former Academic Fellow), Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), and Lisa Larrimore Ouellette Promising…
What The 2020 Election Means For Prescription Drug Policy
At the time of this writing, Former Vice President Joe Biden has been declared the President-elect, with Democrats having retained control of the House of Representatives. However, due to two…
Efficacy and cost of spinal muscular atrophy drugs
Evaluating the benefits, risks, and costs of two drugs to treat spinal muscular atrophy raises questions about the future of rare disease medicines.
Sexual and Reproductive Experiences of Youth with Disabilities in Zimbabwe
The African Disability Rights Yearbook is an Open Access Journal and provides immediate open access to its content on the principle that making research freely available to the public supports…
How Much Can Potential Jurors Tell Us about Liability for Medical AI?
Artificial intelligence (AI) is rapidly entering medical practice, whether for risk prediction, diagnosis, or treatment recommendation. But a persistent question keeps arising: What happens when things go wrong? When patients…
A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways
Complete author list: Louise C. Druedahl, Anna Birna Almarsdóttir, Sofia Kälvemark Sporrong, Marie Louise De Bruin, Hans Hoogland, Timo Minssen (Former Visiting Scholar), Marco van de…
The role of community engagement in addressing bystander risks in research: The case of a Zika virus controlled human infection study
There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder…
Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research
The U.S. Food and Drug Administration (FDA) recently granted an emergency use authorization (EUA) for convalescent plasma to treat patients with coronavirus disease 2019 (COVID-19) (1). Recognizing substantial evidentiary gaps, several…
Reconsidering Health Care Fraud and Abuse Laws
When financial incentives influence physicians’ clinical decision-making, there may be cause for concern. Not all inducements aimed at affecting the utilization of medical services, however, are ill-intentioned. At a…
COVID-19 Clinical Bias, Persons with Disabilities, and Human Rights
Persons with disabilities have historically been discriminated against by society, including fulfilment of the right to equal access to health care.[1] The more egregious practices, historically as well as today,…
Keeping the Patient at the Center of Machine Learning in Healthcare
Char et al. (2020) aspire to provide “a systematic approach to identifying … ethical concerns” around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their…
Rogues and enforcers: Reactions to the National Academies/Royal Society Report on Heritable Human Genome Editing
The HHGE report relies, in substantial part, on using law as an instrument of international governance of heritable genome editing. Although this is understandable, actually enforcing such a system&mdash…
The Right to Health
This Research Handbook combines practitioner and academic perspectives to provide a comprehensive, cutting edge analysis of economic, social and cultural rights (ESCR), as well as the connection between ESCR and…
Critical Approaches To Teaching Health And Human Rights In A Pandemic
The sweeping disruption of the COVID-19 pandemic has generated broad public concern with the connections between population health, health systems, and democracy, on the one hand, and between our neoliberal…
Ethical and Legal Implications of Remote Monitoring of Medical Devices
Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer…
Establishing Good Practice for Human Rights-Based Approaches to Mental Health Care and Psychosocial Support in Kenya
A human rights-based approach (HRBA) to health has long been seen as an important way in which to address public health needs in a manner that is equitable and conducive…
Compensating for research risk: permissible but not obligatory
When payment is offered for controlled human infection model (CHIM) research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions…
The Preemption Clause That Swallowed Health Care: How ERISA Litigation Threatens State Health Policy Efforts
The federal Employee Retirement Income Security Act (ERISA) of 1974 governs the administration of employee benefit plans and is noteworthy in that it includes an extremely broad preemption clause. The preemption…
What is—and should be—the military’s role in COVID-19 research?
Complete authors list: Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow in Ethics of Technology and Biomedical Innovation), Lisa Larrimore Ouellette, Nicholson Price (Former Academic Fellow),…