FDA Regulation of Mobile Health Technologies

NEJM, July 24, 2014
Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New England Journal of Medicine on FDA regulation of new mobile health technologies. From the article:

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Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men

JAMA, July 23, 2014
I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS

Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue of JAMA, arguing for the end of the FDA's lifetime ban on blood donation by men who have sex with men. From…

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Clinical Trials and the Right to Remain Silent

JAMA, July 21, 2014
Michelle Mello, JD, PhD, MPhil and I. Glenn Cohen, JD (Faculty Director)

I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial data. From the article: In this issue of JAMA Internal Medicine, Kernan et al chronicle Yale University’s experience responding to a subpoena…

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JAMA opinion piece calls for ending lifetime ban on blood donation by gay men: Hemophilia groups say policy must be based on science, not politics

Washington Times, July 19, 2014
Cheryl Wetzstein, citing I. Glenn Cohen (Faculty Director)

Gay marriage laws and court rulings against sexual-orientation discrimination are all signs that it’s time for the federal government to change its blood-donor policy for gay and bisexual men, authors said in a commentary released Saturday. The lifetime ban for blood donation by men who…

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Using Big Data To Transform Care: A Briefing on the July 2014 Special Issue of Health Affairs

Health Affairs, July 9, 2014, 9:00am - 12:30pm
Featuring I. Glenn Cohen (Faculty Director)

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless.  The July 2014 issue of Health Affairs, "Using Big Data To Transform Care," examines this new era…

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The Legal and Ethical Concerns That Arise from Using Complex Predictive Analytics in Health Care

Health Affairs, July 8, 2014
I. Glenn Cohen (Faculty Director), Ruben Amarasingham, Anand Shah, Bin Xie, and Bernard Lo

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article just out from Health Affairs entitled “The Legal and Ethical Concerns…

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Some Insurance Companies Ask Their Customers to Cross the Border for Care: Is the practice going to spread?

New Republic, July 7, 2014
Adam Teicholz and I. Glenn Cohen (Faculty Director) and

Faculty Director I. Glenn Cohen has co-authored a new piece in New Republic on the practice adopted by some insurance companies of sending clients across the border for less expensive care.…

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When Religious Freedom Clashes with Access to Care: A NEJM Perspective Article on the SCOTUS Hobby Lobby Decision

NEJM, July 2, 2014
I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), Gregory Curfman

At the tail end of this year's Supreme Court term, religious freedom came into sharp conflict with the government's interest in providing affordable access to health care. In a consolidated opinion in Burwell v. Hobby Lobby Stores and Conestoga Wood Specialties Corp.…

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Choosing not to choose: improving healthcare law by acknowledging how people behave (video)

Harvard Law Today, June 18, 2014

Harvard Law Today featured Cass Sunstein's keynote address at the 2014 Petrie-Flom Center Annual Conference, "Behavioral Economics, Law, and Health Policy." Sunstein, who is the Robert Walmsley University Professor…

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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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