AVAILABLE FOR PREORDER: Big Data, Health Law, and Bioethics

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

About the Book: When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will…

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Germ-Line Gene Editing and Congressional Reaction in Context: Learning From Almost 50 Years of Congressional Reactions to Biomedical Breakthroughs

Journal of Law and Health, Vol. 30 (2017), Issue 1
Russell A. Spivak, I. Glenn Cohen (Faculty Director), and Eli Y. Adashi

Abstract: On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent…

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The Debate over Postmortem Sperm Retrieval of Fallen Soldiers

Jerusalem Post, November 22, 2017
Avishalom Westreich (Visiting Scholar Alumnus)

This essay is based in part on the workshop the Petrie-Flom Center hosted on October 23, 2017, in which then-Visiting Scholar Avishalom Westreich presented his research-in-progress…

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Artificial Intelligence in Health Care: Applications and Legal Issues

The SciTech Lawyer, Vol. 14, no. 1
W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators…

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Are There Non-human Persons? Are There Non-person Humans?

TEDx Cambridge, October 12, 2017
I. Glenn Cohen (Faculty Director)

If we want to live a moral life, how should we treat animals or complex artificial intelligence? What kinds of rights should non-humans have? Harvard Law Professor and world-renowned bioethics expert Glenn…

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Talking about Death

Boston Review, October 5, 2017
Frances Kamm (Senior Fellow Alumna)

From the article: We are now seeing projects directed at the general public asking people to consider how they would like to plan for their demise. Such projects can be very worthwhile, since thinking about the matter in advance could lead to better results for everyone.…

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Contraceptive Coverage and the Balance Between Conscience and Access

JAMA, October 19, 2017
Ronit Y. Stahl and Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)

From the article: When the Obama administration included contraception in the essential benefits package to be covered by employer-sponsored health insurance plans under the Affordable Care Act, it sought to preserve access for women while addressing the concerns…

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TEDxCambridge, Featuring Faculty Director I. Glenn Cohen: October 12, 2017

TEDxCambridge, October 12, 2017, Boston Opera House
I. Glenn Cohen (Faculty Director)

On October 12, 2017, Petrie-Flom Faculty Director I. Glenn Cohen was a distinguished speaker at TedX Cambridge at the Boston Opera House. TEDxCambridge curates one of the largest TEDx conferences in the world featuring 2,500 guests,…

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Innovative Contracting for Pharmaceuticals and Medicaid’s Best-Price Rule

Journal of Health Politics, Policy and Law, September 28, 2017
Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius N. Lakdawalla

From the paper: In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have…

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Mobile Health Innovation and Interagency Coordination

Annals of Health Law, Vol. 26, Issue 22
Rachel E. Sachs (Academic Fellow Alumna)

From the paper: An app that can tell when a phone’s owner is having a seizure.1 A device that transforms a phone into a mobile EKG machine.2 An app that helps patients track their moles over time—and maybe alerts them when they should see a doctor.3 Just…

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Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation

The National Academic Press, October 10, 2017
By I. Glenn Cohen (Faculty Director) and members of the Committee on Issues in Organ Donor Intervention Research

The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. While most related research to date has focused on improving transplantation processes and health outcomes for recipients,…

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Paternalism, reasonableness, and neutrality: a response to commentators

Journal of Medical Ethics, September 2017, Vol. 43 No. 9
Frances Kamm (former Senior Fellow)

From the article (from the commentary on Frances Kamm's earlier article, "Advanced Care and End of Life Care: Some Cautionary Suggestions."

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Your Money or Your Patient’s Life? Ransomware and Electronic Health Records

Annals of Internal Medicine, September 19, 2017
By I. Glenn Cohen (Faculty Director), Sharona Hoffman, and Eli Y. Adashi

The mugger's demand “Your money or your life” is a familiar one. However, in an era of vast hospital computer networks and electronic health records, a novel risk to worry about is, “Your money or your patient's life.” This threat, known…

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PFC Spotlight: Student Fellow Alumna Sara Abiola

Petrie-Flom Center, September 7, 2017

Sara Abiola, PhD, JD, was a Student Fellow during the 2006-2007 academic year, while a second-year law student and first-year health policy doctoral candidate. As part of the…

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Influence, integrity, and the FDA: An ethical framework

Science, Sep 1, 2017: Vol. 357, Issue 6354, pp. 876-877.
Spencer Phillips Hey, I. Glenn Cohen (Faculty Director), Eli Y. Adashi, & Aaron S. Kesselheim

Summary: Among the core missions of the U.S. Food and Drug Administration (FDA) are protecting public health by assuring the safety and efficacy of drugs, biologics, and medical devices and advancing public health by…

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New Serious Illness Program Design and Implementation Framework

Coalition to Transform Advanced Care (C-TAC), August 17, 2017
Khue Nguyen, Theresa Schmidt, Robin Whitney, Gary Bacher, Janice Bell, Sibel Ozcelik (Lead Authors)

As part of the Project on Advanced Care and Health Policy, the Petrie-Flom Center hosted two convenings on Critical…

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Questions About The FDA’s New Framework For Digital Health

Health Affairs Blog, August 16, 2017
Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen (Faculty Director)

From the article: In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates notable shifts in the agency’s approach to digital…

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Administering Health Innovation

Cardozo Law Review, Forthcoming 2018
Rachel E. Sachs (Academic Fellow Alumna)

Abstract Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies…

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Artificial Wombs and Abortion Rights

The Hastings Center Report, July 27, 2017
I. Glenn Cohen (Faculty Director)

Abstract: In a study published in late April in Nature Communications, the authors were able to sustain 105- to 115-day-old premature lamb fetuses—whose level of development was comparable to that of a twenty-three-week-old…

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Public Participation in Drafting of the 21st Century Cures Act

The Journal of Law, Medicine & Ethics, July 14, 2017
Thomas J. Hwang, Rachel E. Sachs (Academic Fellow Alumna), Aaron S. Kesselheim

Abstract The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group lobbying, but the bill and the key changes…

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