Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication

JAMA, June 16, 2014
Michael J. Young, MPhil (Petrie-Flom Student Fellow); Ethan Scheinberg, BTL; Harold Bursztajn, MD

In February 2014, the Department of Health and Human Services (HHS) issued a landmark ruling allowing patients direct access to completed medical laboratory reports. The ruling took effect April 7, 2014, and gives laboratories 180 days from that date to comply. Although this recent change to…

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Tulsa Law Review special issue honoring Founding Faculty Director Einer Elhauge

Tulsa Law Review Vol. 49, Issue 3, 2013
Einer Elhauge (Founding Faculty Director), I. Glenn Cohen (Faculty Director), and others

A symposium honoring the work of Petrie-Flom Founding Faculty Director Einer Elhauge has been published by the Tulsa Law Review. The issue includes Elhauge’s…

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Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings

Institute of Medicine and the National Academy of Sciences, 2014
Adam C. Berger, Sarah H. Beachy, and Steve Olson, featuring I. Glenn Cohen (Faculty Director)

Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes,…

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Physicians, Medical Ethics, and Execution by Lethal Injection

JAMA, May 19, 2014
Robert D. Truog, MD; I. Glenn Cohen, JD (Faculty Director); Mark A. Rockoff, MD

Petrie-Flom Faculty Director I. Glenn Cohen has coauthored a new opinion piece now available through JAMA. From the article: …

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Gallantly fighting windmills? Complexity of a 21st century challenge: Review of The Alzheimer Conundrum, Margaret Lock. Princeton University Press (2013)

The Lancet: Neurology, Vol. 13, Issue 5, May 2014
Robin Pierce (Senior Law and Ethics Associate)

Conundrum presents an intriguing picture of the state of Alzheimer's research and its abundant uncertainties. Through a series of interviews, observations, and informal conversations, medical anthropologist, Margaret Lock traverses the worlds of the laboratory, clinic, and lay public to produce…

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Streamlining Review by Accepting Equivalence

American Journal of Bioethics, Vol. 14, Issue 5, 2014
Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

In their target article, Barchi, Singleton, and Merz (2014) identify several challenges to the review of international research, including regulatory frameworks and review criteria that may overlap or compete across research sites. They articulate a variety of mechanisms by which institutional review…

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What (If Anything) Is Wrong with Human Enhancement? What (If Anything) Is Right with It?

Tulsa Law Review, vol. 49, 2014
I. Glenn Cohen (Faculty Director)

Abstract:  Should human enhancement be prohibited? Subsidized? Mandated? Taxed?  This article is part of a symposium honoring one of my wonderful mentors: Einer Elhauge. It focuses on human…

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The Presumption Against Expensive Health Care Consumption

Tulsa Law Review, Vol. 49, Forthcoming, 2014
Christopher T. Robertson (Affiliate Faculty)

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies…

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Make it Work!:: Breyer on Patents in the Life Sciences

Harvard Law Review 128, 2014
I. Glenn Cohen (Faculty Co-Director)

This short essay is part of a Harvard Law Review Symposium honoring Justice Breyer on his 20th Year on The Supreme Court. It examines Breyer's opinions and impact on the law of patents in the life sciences, and shows how these writings reflect deeper elements of his judicial philosophy and method.

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An Empirical Method for Materiality: Would Conflict of Interest Disclosures Change Patient Decisions?

American Journal of Law and Medicine, Forthcoming, 2014
Roy G. Spece Jr., David V. Yokum, Andrea-Gale Okoro, and Christopher T. Robertson (Petrie-Flom Affiliated Faculty; Former Petrie-Flom Academic Fellow)

Abstract: The law has long been concerned with the agency problems that arise when advisors, such as attorneys or physicians, put themselves in financial relationships that create conflicts of interest. If the financial relationship is “material” to the transactions…

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Was the Medicaid Expansion Coercive?

Routledge, 2014
I. Glenn Cohen (Petrie-Flom Faculty Co-Director)

In The Affordable Care Act Decision: Philosophical and Legal Implications, Fritz Allhoff and Mark Hall, eds. In this book chapter on the ACA decision, NFIB v. Sebelius, I focus on the Court's holding that the Medicaid expansion was unconstitutional. I ask by what…

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The “Problem” with the European Problem/Solution Approach to Inventive Step

Los Angeles Intellectual Property Law Association, Wegner's Writings, February 24, 2014
Harold C. Wegner, reviewing Timo Minssen (Petrie-Flom Visiting Scholar)

From the review: Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges…

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Patent Trolling: Why Bio & Pharmaceuticals are at Risk

Robin Feldman and W. Nicholson Price II (Petrie-Flom Academic Fellow)

Abstract: Patent trolls — also known variously as non-practicing entities, patent assertion entities, and patent monetizers — are a top priority on legislative and regulatory reform agendas. In the modern debates, however, the biopharmaceutical industry goes conspicuously…

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Will your clothing spy on you?: A scholar warns of the potential for wearable technology to annihilate privacy for good.

Fortune, February 13, 2014
David Whitford, on I. Glenn Cohen (Petrie-Flom Faculty Co-Director)

[...] Like it or not, we have entered the era of assumed ubiquitous snooping, and we have not begun to parse the implications. That was my takeaway from Cohen's lecture, "The Ethicist's and the Lawyer's New Clothes: The Law and Ethics of Smart Clothes," which will be available for free…

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Undocumented Injustice?: Medical Repatriation and the Ends of Health Care

NEJM, February 13, 2014
Michael J. Young, M.Phil. (Petrie-Flom Academic Fellow), and Lisa Soleymani Lehmann, M.D., Ph.D.

Quelino Jimenez came to the United States at 18 years of age, seeking work to provide financial support to his family of 11 in Mexico. Jimenez found a construction job in Chicago, where he worked without a legal work or residence permit for more than a year until he sustained injuries after a 20-ft…

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Religious groups to back Obamacare contraceptive mandate: Face dilemma over freedom, government rules on women

Washington Post, February 4, 2014
Tom Howell, Jr. quoting Holly Fernandez Lynch (Petrie-Flom Executive Director)

[...] In its filing, the AJC said the case presents a rare instance in which they see a clash between religious liberty and the equal rights of women. They said the government’s mandate ultimately promotes women’s health “in the least restrictive means available.” …

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Ethics and Ontology in Deep Brain Stimulation

Neuroscience, January 30, 2014
Michael J. Young (Petrie-Flom Student Fellow)

Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems…

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Legal Aspects of Biobanking as Key Issues for Personalized Medicine & Translational Exploitation

Timo Minssen (Petrie-Flom Visiting Scholar) and Jens Schovsbo

Abstract: This perspective-article provides an overview on selected legal aspects of biobanking. It discusses these issues with a focus on public biobanks in a university setting and the specific challenges posed by personalized medicine (PM). We conclude that any decisions as…

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NEW BOOK: Science and Technology in International Economic Law: Balancing Competing Interests

Routledge, 2014
Bryan Mercurio and Kuei-Jung Ni (Petrie-Flom Visiting Scholar), editors

Science and technology plays an increasingly important role in the continued development of international economic law. This book brings together well-known and rising scholars to explore the status and interaction of science, technology and international economic law. The book reviews the place of…

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Defining mental illnesses: can values and objectivity get along?

BMC Psychiatry 13:346, December 24, 2013
Dominic Sisti, Michael Young (PFC Student Fellow), and Arthur Caplan

Abstract Background The creation of each edition of the Diagnostic and Statistical Manual (DSM) of psychiatry has proven enormously controversial. The current effort to revise the ‘bible’ of disorder definitions for the field of mental health is no exception. The controversy…

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