On the Human Right to Health: Statistical Lives, Contingent Persons, and Other Difficult Questions

Human Rights, Democracy, and Legitimacy in a World of Disorder , 2018
I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has written a chapter in the fortchoming book "Human Rights, Democracy, and Legitimacy in a World of Disorder," (Cambridge University Press, edited by Silja Voeneky and Gerald Neuman) that engages with the philosophical concept of a human right…

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Health Insurance’s Secondary Cost Problem: Market and Mandatory Solutions to Balance Billing and Other Symptoms

Harvard Law & Policy Review, Forthcoming
Matthew J.B. Lawrence (Academic Fellow Alumnus)

From the abstract: This Article identifies a fundamental problem with health insurance and, so, contemporary American health care. While competition pushes health insurers to minimize the primary costs of their plans—monthly premiums and periodic out-of-pocket…

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HIPAA and Protecting Health Information in the 21st Century

JAMA, May 24, 2018
I. Glenn Cohen (Faculty Director) and Michelle M. Mello

Faculty Director I. Glenn Cohen has co-authored a new opinion piece in JAMA that addresses the adequacy of HIPAA in protecting electronic health data in light of the launch of the Trump administration's…

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Circumvention Medical Tourism and Cutting Edge Medicine: The Case of Mitochondrial Replacement Therapy

Indiana Journal of Global Legal Studies, May 12, 2018
I. Glenn Cohen (Faculty Director)

From the article: “Medical Tourism” is the travel of patients from a home country to a destination country for the primary purpose of receiving health care. “Circumvention Tourism” is a sub-type of such travel where the motivation is circumventing…

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The Ethics of Medicaid’s Work Requirements and Other Personal Responsibility Policies

JAMA, May 7, 2018
Harald Schmidt and Allison K. Hoffman (Academic Fellow Alumna)

From the paper:  Breaking controversial new ground, the Centers for Medicare & Medicaid Services (CMS) recently invited states to consider establishing work requirements as a condition of receiving Medicaid benefits. Noncompliant beneficiaries may lose some…

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Berkeley Technology Law Journal, May 10, 2018
W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Innovation is a primary source of economic growth, and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal of tools to promote innovation, but legal academic studies of…

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Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines

Health Affairs , May 2018
Lisette Pregelj, Thomas J. Hwang, Damian C. Hine, Evan B. Siegel, Ross T. Barnard, Jonathan J. Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the article: Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during clinical trials suggests such medicines will reach…

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Addressing Financial Barriers to Enrollment in Clinical Trials

JAMA Oncology, April 19, 2018
Emily A. Largent and Holly Fernandez Lynch (Former Executive Director)

From the article: Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement. One means of increasing patient participation rates is to reduce associated financial burdens. In several states, efforts are under way…

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Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options

Trends in Molecular Medicine, Volume 24, Issue 5 (May 2018)
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract Mutant mitochondrial DNA gives rise to a broad range of incurable inborn maladies. Prevention may now be possible by replacing the mutation-carrying mitochondria of zygotes or oocytes at risk with donated unaffected counterparts. However, mitochondrial…

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REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Harvard University Embryonic Stem Cell Research Oversight (“ESCRO”) Committee, April 2018

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD…

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Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough an

Journal of Clinical Oncology , April 24, 2018
Thomas J. Hwang, Jessica M. Franklin, Julie C. Lauffenburger, Bishal Gyawali, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer…

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Redesigning Provider Payments to Reduce Long-Term Costs by Promoting Healthy Development

National Academy of Medicine, April 20, 2018
Nathaniel Z. Counts (Student Fellow alumnus), Neal Halfon, Kelly J. Kelleher, J. David Hawkins, Laurel K. Leslie, Thomas F. Boat, Mary Ann McCabe

From the article: Cognitive, aff ective, and behavioral health (CAB) conditions are among the costliest and fastest growing in the United States. An array of interventions is demonstrated to be eff ective in preventing or mitigating these conditions and off ers the…

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The FDA Breakthrough-Drug Designation — Four Years of Experience

The New England Journal of Medicine, April 12, 2018
Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim,

This article is behind a paywall. Harvard affiliates can access the full text via Hollis +. From the article: In 2012, Congress created the “breakthrough therapy” designation to expedite…

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New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, April 17, 2018
Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility. …

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Bystander risk, social value, and ethics of human research

Science, April 13, 2018, Volume 360, Issue 6385
S. K. Shah, J. Kimmelman, A. D. Lyerly, H. F. Lynch (Former Executive Director), F. G. Miller, R. Palacios, C. A. Pardo, C. Zorrilla

From the article: Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And…

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On Scarcity and the Value of Clinical Trials

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Luke Gelinas (Senior Researcher), Holly Fernandez Lynch (Former Executive Director), Barbara E. Bierer, & I. Glenn Cohen (Faculty Director)

From the artice: Allocation of scarce goods and resources is a common concern in the health care context, from intensive care unit (ICU) beds, to extracorporeal membrane oxygenation (ECMO) machines, to vaccines, to organs for transplant. Problems raised by scarcity…

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Mutual Obligations in Research and Withholding Payment From Deceptive Participants

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Holly Fernandez Lynch (Former Executive Director), Luke Gelinas (Senior Researcher), & Emily A. Largent

From the article: Paying research participants can be ethically charged, both when payment is offered and—as demonstrated in this case—when it is withheld. When individuals undergoing screening intentionally deceive investigators as to their eligibility,…

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Assisted Reproduction in Israel: Law, Religion, and Culture

Brill Research Perspectives, March 20, 2018
Avishalom Westreich

From the article: The theme of this composition is the right to procreate in the Israeli context. Our discussion of this right includes the implementation of the right to procreate, restrictions on the right (due to societal, legal, or religious concerns), and the…

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NOW AVAILABLE! Big Data, Health Law, and Bioethics

Cambridge University Press, March 2018
I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena

Now available - order it online!  From the book: When data from…

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Prevalence of Publicly Available Expanded Access Policies

Clinical Pharmacology & Therapeutics, March 23, 2018
Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

From the Article: The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments from their manufacturers. The 21st Century Cures Act…

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