The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine

American Journal of Bioethics, September 20, 2018
Craig M. Klugman, Laura B. Dunn, Jack Schwartz, and I. Glenn Cohen (Faculty Director)

From the abstract:  Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved…

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Smart pills can transmit data to your doctors, but what about privacy?

New Scientist, September 19, 2018
I. Glenn Cohen (Faculty Director) and Alex Pearlman (Communications Manager)

From the article:  Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by the US Food and Drug Administration (FDA), in November 2017. Its roll-out…

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Limiting State Flexibility in Drug Pricing

NEJM, September 13, 2018
Nicholas Bagley and Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that…

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Are Fraud and Abuse Laws Stifling Value-Based Care?

NEJM Catalyst , September 12, 2018
Carmel Shachar (Executive Director)

From the article:  While health care delivery and financing should not be a free-for-all, designing the exemptions to explicitly conform to specific regulatory programs does not best serve the system. Even when a medical provider decides that a value-based care…

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In whose best interests: The impact of globalised medicine on on withdrawal of treatment decisions in the UK

New Law Journal, September 7, 2018
David Locke & Carmel Shachar (Executive Director)

From the paper: As a feature of the progressive globalisation of medicine, the recent, heavily litigated, trio of cases involving the withdrawal of treatment from infants (Charlie Gard, Isiah Haastrup and Alfie Evans) has highlighted what is asserted…

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The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents

Applied Health Economics and Health Policy, August 2018, Vol. 14, Issue 73
Jonathan J. Darrow (Student Fellow Alumnus), Reed F. Beall, Aaron S. Kesselheim

From the abstract:  Background Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally been…

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Revisiting the Limits of Professional Autonomy: The Intersex Rights Movement's Path to De-Medicalization

Harvard Journal of Law and Gender, Vol. 41, No. 1
Maayan Sudai (Student Fellow Alumna)

From the paper: Social movements that seek to change biomedical policy face the particularly challenging task of effectively contesting the scientific and normative basis used to justify medical professional practices in the present. Such is the case of the intersex…

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We Have to Be Smart About Artificial Intelligence in Medicine: When the technology is complicated, opaque, changing, and absolutely vital to the health of a patient, how do we make sure it works as promised?

Slate, August 15, 2018
W. Nicholson Price II (Academic Fellow Alumnus)

From the article: For millions of people suffering from diabetes, new technology enabled by artificial intelligence promises to make management much easier. Medtronic’s Guardian Connect system promises to alert users 10 to 60 minutes before they hit…

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Drug Pricing Policy: HHS Introduces Step Therapy In Medicare Advantage

Health Affairs Blog, August 14, 2018
Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Last Tuesday, the Centers for Medicare and Medicaid Services (CMS) took its latest action in the area of drug pricing. CMS gave Medicare Advantage (MA) plans the ability to use step therapy, in which a patient may be required by their…

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Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act

JAMA, August 13, 2018
Holly Fernandez Lynch (former Executive Director and Academic Fellow Alumna), Patricia J. Zettler, Ameet Sarpatwari

Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article:

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Perspective: Will Courts Allow States to Regulate Drug Prices?

NEJM, August 8, 2018
Christopher Robertson (Academic Fellow Alumnus)

From the article: Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively…

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Administering Health Innovation

Cardozo Law Review, Volume 39, Issue 6 (July 2018)
Rachel E. Sachs (Academic Fellow Alumna)

From the article: 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…

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Delinking Reimbursement

Minnesota Law Review, Vol. 102, Issue 6 (July 2018)
Rachel Sachs (Academic Fellow Alumna)

Introduction: Recently, scholars and policymakers on both sides of the aisle have become interested in the legal and regulatory structures surrounding pharmaceutical approval and reimbursement in this country. Scholars focusing on the Food and Drug Administration…

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Drug Approval in a Learning Health System

Minnesota Law Review, 2018
W. Nicholson Price

From the abstract: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA — and the health system generally — should gather information after drugs are approved to learn…

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Drug Approval in a Learning Health System

Minnesota Law Review, Forthcoming, July 30, 2018
W. Nicholson Price (Academic Fellow Alumnus)

From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn…

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Defensive Medicine: Evidence from Military Immunity

National Bureau of Economic Research Working Paper Series , July 2018
Michael D. Frakes (Former Academic Fellow) and Jonathan Gruber

From the abstract:  We estimate the extent of defensive medicine by physicians, embracing the no-liability counterfactual made possible by the structure of liability rules in the Military Heath System. Active-duty patients seeking treatment from military facilities…

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Patent term restoration for top-selling drugs in the USA

Drug Discovery Today, July 25, 2018
Reed F. Beall, Jonathan Darrow (Former Student Fellow), and Aaron S. Kesselheim

From the article:  Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost to clinical testing and regulatory review, current law provides…

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Medical Liability and Treatment Relationships

Wolters Kluwer, Fourth edition, 2018
Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley, I. Glenn Cohen (Faculty Director)

From the description:  Medical Liability and Treatment Relationships is based on Part I, “The Provider and the Patient,” of parent book Health Care Law and Ethics, and adds additional coverage of professional licensure and regulating access to drugs, and new…

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Bioethics and Public Health Law

Wolters Kluwer, Fourth edition, 2018
Mary Anne Bobinski, David Orentlicher, I. Glenn Cohen (Faculty Director), Mark A. Hall

From the description:  Financial and ethical issues are integrated into this concise and engaging treatment of Bioethics and Public Health Law. The complex relationship between patients, providers, the state, and public health institutions are explored through high-interest cases,…

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Health Care Law and Ethics

Wolters Kluwer, Ninth edition, 2018
Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley, I. Glenn Cohen (Faculty Director)

From the description:  Health Care Law and Ethics, Ninth Edition offers a relationship-oriented approach to health law—covering the essentials, as well as topical and controversial subjects. The book provides thoughtful and teachable coverage of every aspect of health care law.…

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