Shadow health records meet new data privacy laws

Science, February 1, 2019
by W. Nicholson Price (Academic Fellow Alumnus), Margot E. Kaminski, Timo Minssen (Former Visiting Scholar), Kayte Spector-Bagdad

From the article: "Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information,…

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A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance

AI-Health Working Group White Paper, January, 2019
David Arney, Max Senges, Sara Gerke et al

From the abstract:   AI-enabled health technology holds significant promise for improving health outcomes and clinical workflows. However, it also generates challenges for health data governance and security. More specifically, apps that…

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Drugmakers Drag Feet as Congress Drills Into Prescription Prices

Bloomberg Government, January 31, 2019
By Alex Ruoff and Jeannie Baumann, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "'Pharmaceutical companies look at what happened to Martin Shkreli and Heather Bresch at Mylan and they don’t want their company to be the face of this year’s drug pricing scandal,' Rachel Sachs, a professor…

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Luxturna: FDA documents reveal the value of a costly gene therapy

Drug Discovery Today, January 31, 2019
by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: "In 2017, the US Food and Drug Administration (FDA) approved voretigene neparvovec‐rzyl (Luxturna), a gene therapy used to treat a rare form of inherited blindness. Widely described as a curative treatment that ‘restores…

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Power, Politics and Knowledge Claims: Sexual and Reproductive Health and Rights in the SDG Era

Global Policy , January 28, 2019
by Alicia Ely Yamin (Senior Fellow for GHRP)

From the article: "The selection of Sustainable Development Goals (SDGs) , targets and indicators for sexual and reproductive health and rights (SRHR) can only be understood in the light of struggles to advance these rights amid a context of the growing…

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Association Between Financial Incentives and Participant Deception About Study Eligibility

JAMA, January 25, 2019
by Holly Fernandez Lynch (Former Executive Director) et al, and Emily Largent (Student Fellow Alumna)

From the article: "Question: Is payment associated with participant deception about research eligibility and, if so, is higher payment associated with more deception? Findings: In this randomized survey…

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The Lumbering Crawl Toward Human Germline Editing

Journal of Law, Medicine & Ethics, January 10, 2019
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article:  It is in the nature of novelty that consensus is hard to come by. Such is clearly the lot of groundbreaking biomedical advances. History is no stranger to this phenomenon. The prospect of human germ-line editing is no exception.…

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Privacy in the age of medical big data

Nature Medicine, January 7, 2019
by W. Nicholson Price (Academic Fellow Alumnus) and I. Glenn Cohen (Faculty Director)

From the article:  "Big data has come to medicine. Its advocates promise increased accountability, quality, efficiency, and innovation. Most recently, the rapid development of machine-learning techniques and artificial intelligence (AI) has promised…

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Prescription Drug Policy: The Year In Review, And The Year Ahead

Health Affairs blog, January 3, 2019
by Rachel Sachs (Academic Fellow Alumna)

From the article:  This past year was once again filled with health policy news. Unlike 2017's congressional efforts to repeal the Affordable Care Act (ACA), 2018's news focused more on executive actions around health…

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An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Nature Biotechnology, January 3, 2019
Timo Minssen (Former Visiting Scholar), Aaron S. Kesselheim, and Jonathan Darrow (Student Fellow Alumnus)

From the article: "A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges remain. In…

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A Smarter Way to Provide Epinephrine at School

JAMA Pediatrics, December 21, 2018
by Austin Frakt and Rachel Sachs (Academic Fellow Alumna)

From the article:  Despite the years-long public outcry over high prescription drug prices, public concern has not yet coalesced into major policy change. As a result, Americans remain uncomfortable with pharmaceutical prices, spending, and pharmaceutical…

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A Method for Approximating Future Entry of Generic Drugs

Value in Health, December, 2018
by Reed F. Beall, Jonathan J. Darrow (Student Fellow Alumnus), and Aaron S. Kesselheim

From the abstract:  Objectives To develop and test a method for approximating generic entry of top-selling drugs. Methods

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Big data and black-box medical algorithms

Science Translational Medicine, December 12, 2018
by W. Nicholson Price (Academic Fellow Alumnus)

From the article: "Machine-learning algorithms have been predicted to come into widespread use in the areas of prognosis, radiology, and pathology within the next few years, and diagnosis within the next decade, substantially increasing the power…

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Of Parachutes and Participant Protection:: Moving Beyond Quality to Advance Effective Research Ethics Oversight

Journal of Empirical Research on Human Research Ethics, December 12, 2018
by Holly Fernandez Lynch (Former Executive Director), Stuart Nicholls, Michelle N. Meyer, and Holly A. Taylor

From the abstract:  There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important…

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Health as a Human Right, Medicare for All, and the Evolution of the American Health Care Debate

Take Care Blog, December 11, 2018
By Carmel Shachar (Executive Director), Alex Pearlman (Communications Manager) and I. Glenn Cohen (Faculty Director)

From the article: The United States famously does not have an explicit federal constitutional right to health. By contract, the “enjoyment of the highest attainable standard of health” was defined in the World Health Organization…

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Access to Personal Information for Public Health Research: Transparency Should Always Be Mandatory

Canadian Journal of Bioethics, December 7, 2018
by Jean-Christophe BĂ©lisle-Pipon (Visiting Researcher)

From the article: "In Québec, the Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information provides an exception to transparency to most public institutions where public health research is…

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AVAILABLE FOR PRE-ORDER! Transparency in Health and Health Care in the United States

Cambridge University Press, Forthcoming June 2019
Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Barbara J. Evans (eds.)

This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health policy buzzword,…

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The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area

JAMA, December 3, 2018
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article:  Editing the genome of human gametes or embryos is a disruptive unactualized technology and continues to be the subject of a wide range of concerns. The chief concern is the safety and efficacy of such an intervention and…

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Administration Proposes Strategies To Lower Pharmaceutical Prices In Medicare Part D

Health Affairs, November 28, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: "On Monday, the Trump administration proposed a set of changes that have the potential to lower the prices of some pharmaceuticals paid for through Medicare Part D. As set out in the proposed rule, the plan has…

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On Repugnance, Distribution, and the Global Kidney Exchange: Comment

Journal of Institutional and Theoretical Economics (JITE), November 27, 2018
I. Glenn Cohen (Faculty Director)

From the article:  Krawiec opens the article by quoting Alvin Roth’s framing of repugnance as a “distaste for certain kinds of transactions [that] can be a real constraint on markets and how they are designed” (Roth, 2007, p.…

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