Resources: Affiliate Scholarship
The Future Is P-Tau—Anticipating Direct-to-Consumer Alzheimer Disease Blood Tests
Recent studies suggest blood levels of phosphorylated tau (p-tau) isoforms can detect both the tau and amyloid pathologies that define Alzheimer disease (AD).1 More research is needed to replicate these…
Lost on the High Seas without a Safe Harbor or a Shield? Navigating Cross-Border Transfers in the Pharmaceutical Sector After Schrems II Invalidation of the EU-US Privacy Shield
This paper analyzes the impact and associated legal challenges of cross-border data transfers in the pharmaceutical sector after the recent Court of Justice of the European Union (CJEU) decision in…
Accuracy of US College Football Players’ Estimates of Their Risk of Concussion or Injury
Importance Despite increased concern about the health consequences of contact sports, little is known about athletes’ understanding of their own risk of sports-related injury. Objective To assess whether college…
Healthcare worker intentions to receive a COVID-19 vaccine and reasons for hesitancy: A survey of 16,158 health system employees on the eve of vaccine distribution
Healthcare workers (HCWs) have been recommended to receive first priority for limited COVID-19 vaccines. They have also been identified as potential ambassadors of COVID-19 vaccine acceptance, helping to ensure that…
Evidence Supporting the Value of Surgical Procedures: Can We Do Better?
There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence…
US Public Attitudes Toward COVID-19 Vaccine Mandates
Ending the coronavirus disease 2019 (COVID-19) pandemic through vaccination will require sufficient uptake, possibly through mandatory vaccination. At present, certain vaccines are required for children to attend school. Although vaccine mandates…
When Machine Learning Goes Off the Rails
What happens when machine learning—computer programs that absorb new information and then change how they make decisions—leads to investment losses, biased hiring or lending, or car…
How can policymakers encourage COVID-19 vaccine trials for children?
Complete author list: Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), Lisa Larrimore Ouellette, Nicholson Price (Former Academic Fellow), and Rachel Sachs (Former Academic Fellow) The…
Restoring The Preemption Status Quo: Rutledge, ERISA, And State Health Policy Efforts
On Dec 10, 2020, the Supreme Court issued its opinion in Rutledge v. Pharmaceutical Care Management. While this case was perhaps overshadowed by recent election litigation, it is an important development in…
Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
A foundational requirement of ethical research is that persons provide informed consent. Yet, there are exceptions that promote valuable research without unduly compromising participants' interests. Applicable regulations for federally funded…
Realizing Present and Future Promise of DIY Biology and Medicine through a Trust Architecture
Complete author list: Lisa M. Rasmussen, Christi J. Guerrini, Todd Kuiken, Camille Nebeker, Alex Pearlman (Former Communications Manager), Sarah B. Ware, Anna Wexler, and Patricia J. Zettler. Abstract The speed…
Understanding the Perspectives of Seniors on Dementia and Decision-Making
Background The legal doctrine of capacity, which governs legally-authorized intervention in the decision-making of persons with dementia, has been subject to recent scholarly criticism and reform efforts. Such efforts require…
What are emergency use authorizations, and do they guarantee that a vaccine or drug is safe?
In coming days, the Food and Drug Administration is likely to authorize new COVID-19 vaccines based on applications submitted by two companies. These authorizations have happened very fast in a…
The Stellenbosch Consensus on the International Legal Obligation to Collaborate and Assist in Addressing Pandemics
Full author list: Margherita M. Cinà, Steven J. Hoffman, Gian Luca Burci, Thana Cristina de Campos, Danwood Chirwa, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin,…
Social, cultural and economic aspects of antimicrobial resistance
Complete author list: Timo Minssen (Former Visiting Scholar), Kevin Outterson, Susan Rogers Van Katwyk, Pedro Henrique D. Batista, Clare I. R. Chandler, Francesco Ciabuschi, Stephan Harbarth, Aaron S. Kesselheim, Ramanan…
Can AI Fairly Decide Who Gets an Organ Transplant?
Health care organizations, like many other enterprises, face steep challenges in their attempt to maximize operational efficiency in the face of resource constraints. Whether it is a hospital’s…
Advancing Artificial Intelligence in Health Settings Outside the Hospital and Clinic
Complete author list: Nakul Aggarwal, Mahnoor Ahmed, Sanjay Basu, John J. Curtin, Barbara J. Evans, Michael E. Matheny, Shantanu Nundy, Mark P. Sendak, Carmel Shachar (Executive Director), Rashmee U. Shah,…
What administrative actions might we expect on COVID-19 in President-elect Biden’s administration?
Complete author list: Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), Lisa Larrimore Ouellette, and Nicholson Price (Former Academic Fellow) When…
At the Epicenter of COVID-19–the Tragic Failure of the Global Supply Chain for Medical Supplies
Complete author list: Sonu Bhaskar, Jeremy Tan, Marcel L. A. M. Bogers, Timo Minssen (Former Visiting Scholar), Hishamuddin Badaruddin, Simon Israeli-Korn, and Henry Chesbrough. The tragic failure of the global…
Administration Finalizes Drug Pricing Rebate 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…