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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The Promise and Peril of Emerging Reproductive Technologies

Science Translational Medicine, January 11, 2017, Vol. 9, Issue 372
By I. Glenn Cohen (Faculty Director), George Q. Daley, and Eli Y. Adashi

Harvard scientists call for proactively addressing legal, ethical challenges before an experimental technique reaches the clinic At a glance: In-vitro gametogenesis…

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Behavioral science suggests that Obamacare may not change as much as Republicans claim

STAT, January 3, 2017
Christopher R. Robertson (Academic Fellow Alumnus), I. Glenn Cohen (Faculty Director), & Holly Fernandez Lynch (Executive Director)

From the article: In the waning days of his administration, President Obama encouraged Americans to take advantage of the opportunity to get health insurance in what may be the last open enrollment period under the Affordable Care Act. Given…

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How Donald Trump’s Health Secretary Pick Endangers Women

New York Times, December 28, 2016
Allison K. Hoffman (Academic Fellow Alumna) and Jill R. Horwitz

LOS ANGELES — With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women. It is regrettable, but not surprising, that Mr. Trump has nominated…

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What’s Confusing Us About Mental Health Parity

HealthAffairs Blog, December 22, 2016
Nathaniel Counts (Student Fellow alumnus), Timothy Clement, Amanda Mauri, Paul Gionfriddo, and Garry Carneal

The Mental Health Parity and Addiction Equity Act (MHPAEA) has been law since 2008. MHPAEA provided that health plans could not limit mental health or substance use disorder benefits in a way that was more restrictive than how most medical/surgical benefits were limited. This sounds simple…

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The Legality of Biometric Screening of Professional Athletes

The American Journal of Bioethics , 2017, Vol. 17, Issue 1
Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate) & Holly Fernandez Lynch (Executive Direc

From the article: In their thoughtful article, “Tracking U.S. Professional Athletes: The Ethics of Biometric Technologies,” Katrina Karkazis and Jennifer Fishman do an excellent job of outlining the concerns associated with the widespread adoption of biometric…

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The Oxford Handbook of U.S. Healthcare Law

The Oxford Handbooks, July 2016 (online), January 2017 (print)
Edited by I. Glenn Cohen (Faculty Director), Allison K. Hoffman (Academic Fellow Alumna), and William M. Sage

Abstract: The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law through the words and insights of the best scholars in the field. The content is valuable to readers with no background in the field and to those who write, teach, practice, or make policy…

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