Regulating Black-Box Medicine

Michigan Law Review, March 21, 2017
W. Nicholson Price II

From the abstract: Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process…

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The Purpose of My Death: Death, Dying, and Meaning

Ethics, Vol. 127, no. 3, April 2017
Frances Kamm

From the article: My purpose in this essay is to consider some views about death and dying presented in two recent books. One book is Death by philosopher Shelly Kagan and the second is Being Mortal by medical doctor Atul Gawande. I focus on their different views…

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Time is Money: An Empirical Assessment of Non-Economic Damages Arguments

Washington University Law Review, Forthcoming; U Denver Legal Studies Research Paper No. 16-21; Arizona Legal Studies Discussion Paper No. 16-12, March 2, 2017
John E. Campbell, Bernard Chao, and Christopher T. Robertson (Academic Fellow Alumnus)

From the abstract: Non-economic damages (pain and suffering) are the most significant and variable components of liability. Our survey of 51 U.S. jurisdictions shows wide heterogeneity in whether attorneys may quantify damages as time-units of suffering (“per…

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UPCOMING! Annual Health Law Conference: Between Complacency & Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases

Northeastern University School of Law, April 14, 2017
Holly Fernandez Lynch (Executive Director)

From the event:  Emerging infectious diseases (EIDs) such as Ebola and the Zika virus pose potentially grave threats to human health. They can also incite overreations that lead to the scapegoating of vulnerable populations and counter-productive public health…

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The NFL Combine: Pro football’s intrusive, and mandatory, job interview

Washington Post, February 26, 2017
Rick Maese, quoting Glenn Cohen (Faculty Director)

From the article: While there could be a gray area between tests that measure performance and those that examine health, Glenn Cohen, a Harvard law professor who co-authored the study, says the list of questionable exams the NFL requires of draft prospects is long:…

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Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The American Journal of Bioethics, Volume 17, 2017 - Issue 3
Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer

Part of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical…

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Mitochondrial Replacement Therapy: Unmade in the USA

JAMA Forum, February 14, 2017
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article: Mitochondrial replacement therapy, an experimental approach that takes aim at maternally inherited mitochondrial diseases, is on the verge of being implemented in the United Kingdom, almost 2 years after it received approval from the UK Parliament.…

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Mitochondrial Replacement Therapy: Unmade in the USA

The JAMA Forum, February 14, 2017
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article: Mitochondrial replacement therapy, an experimental approach that takes aim at maternally inherited mitochondrial diseases, is on the verge of being implemented in the United Kingdom, almost 2 years after it received approval from the UK Parliament.…

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Common Rule Revisions: Impact of Public Comment, and What’s Next?

The Hastings Center Blog, February 8, 2017
By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

From the blog post: On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule”…

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Advanced and end of life care: cautionary suggestions

Journal of Medical Ethics, February 7, 2017 (online)
Frances Kamm (former Senior Fellow)

Abstract: This article considers some clinical and population level approaches to advanced care of chronic conditions and end of life care. One approach aims to follow patient values and preferences about acceptable end of life (EOL) as elicited by questionnaires. The grounds…

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A New Day For Oversight Of Human Subjects Research

HealthAffairs, February 6, 2017
Holly Fernandez Lynch (Executive Director)

Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23rd,…

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Evaluating NFL Player Health and Performance: Legal and Ethical Issues

University of Pennsylvania Law Review, Vol. 165, No. 2, 2017
Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate), and Holly Fernandez Lynch (Executive Di

Abstract:       This Article follows the path of a hypothetical college football player with aspirations to play in the National Football League, explaining from a legal and ethical perspective the health and performance evaluations he will likely…

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Traveling for Assisted Suicide

In Euthanasia and Assisted Suicide: Global Views on Choosing to End Life (Michael J. Cholbi, ed.), Praeger, 2017 (forthcoming)
I. Glenn Cohen (Faculty Director)

This book addresses key historical, scientific, legal, and philosophical issues surrounding euthanasia and assisted suicide in the United States as well as in other countries and cultures. Euthanasia was practiced by Greek physicians as early as 500 BC. In the 20th century, legal and ethical…

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Bioethics in the law

The Hastings Center Report, January/February 2017, Vol. 47, Issue 1
Zachary E. Shapiro (Student Fellow Alumnus)

Abstract The role of law in bioethics is clear. Laws are enforcement tools: they govern which conditions qualify an individual for disability benefits, or what oversight is necessary for clinical trial protocols, or how patent applications for medical devices should be regulated.…

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Do ethics demand evaluations of public health laws?: Shifting scientific sand and the case of youth sports-related TBI laws

Journal of Health Care Law Policy, 2016, Vol. 19, Issue 1
Kerri McGowan Lowrey, Stephanie R. Morain, and Christine M. Baugh (Student Fellow Alumna)

From the article: Ideally, public health laws would be developed on a robust base of scientific, epidemiologic, and medical data and enacted independent of the various political forces at play. In reality, of course,…

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When clinical trials compete: prioritising study recruitment

Journal of Medical Ethics, January 20, 2017 (online)
Luke Gelinas (Clinical Research Ethics Fellow), Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, and I. Glenn Cohen (Faculty Director)

Abstract It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for…

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Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule

IRB: Ethics & Human Research, January-February 2017, Vol. 39, Issue 1
Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Barbara E. Bierer

Abstract: At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to develop rules with the force…

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Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual…

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Promoting healthcare innovation on the demand side

Journal of Law and the Biosciences, January 16, 2017 (online first)
W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg

Abstract: Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also rely on these same firms—and on similar incentives—to develop information about the…

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Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-1480 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT   AMGEN INC., AMGEN MANUFACTURING, LTD., and AMGEN USA, INC., Plaintiffs-Appellees, v. SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB LLC, f/d/b/a AVENTIS, Defendants-Appellants.

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