Photograph of a green cow statue in a field

Exploring the Future of Meat: Academy of Food Law & Policy 2nd Annual Conference at Georgia State University, Dec. 10, 2019

By Nicole Negowetti

Sustainably feeding a growing population with healthy diets is a pressing global challenge. The role of meat in such diets is a deeply contentious issue that has public health, animal welfare, food systems, farming, and environmental experts and advocates weighing in on the issue. As we learn more about the impacts of meat production and consumption on human and environmental health and animal welfare, meat consumption is changing. In North America, eaters are heeding recommendations to reduce, replace, or eliminate meat in their diets; however, global meat production and consumption continues to rise.

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Illustration of a pill with a sensor embedded

Ethical and legal issues of ingestible electronic sensors

This post originally appeared in Device and Materials Engineering. You can read it here.

By Sara Gerke & I. Glenn Cohen

In our new paper, we discuss the ethical challenges of ingestible electronics sensors (IESs; also called “smart pills”) and examine the legal regulation of such sensors in the United States and Europe.

IESs are increasingly being developed for improving health outcomes. One such use could facilitate monitoring and promoting medication adherence. Once swallowed, an IES connects with a wearable sensor that can detect and record valuable data, including behavioral and physiological metrics or the time of drug intake. The wearable sensor subsequently sends the collected data to a computing device (e.g., a smartphone) that processes and displays the information. There is also the option to link the display function with a cloud database for data sharing with the patient’s doctor or family.

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Photo of a stethoscope, gavel, and book

The End of Dramatic Legal Saga: French Patient Vincent Lambert has Died

By Audrey Lebret

There are few cases as publicized in France as the story of Vincent Lambert, a patient in a vegetative state whose fate deeply divided his family. On June 28, 2019, the Cour de Cassation signed the last substantial decision of the Vincent Lambert case, after six years of proceedings. The patient died on July 11, 2019.

The facts

In 2008, Vincent Lambert was involved in a traffic accident that left him in a quadriplegic state and suffering from massive brain trauma. In 2011, a medical evaluation described his state as minimally conscious. Doctors tried to establish a code of communication to which he was never responsive. Nonetheless, doctors tracked some behaviors that they interpreted as an opposition to treatments and a refusal to live (Conseil d’Etat judgement, at 20). In 2013, his doctor initiated a procedure with the agreement of Mr. Lambert’s wife in order to interrupt the treatments. That initiated a lengthy court battle.

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Image of binary and dna

Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and regulation of data sharing in the health and life sciences. Cutting-edge biomedical research strongly demands high-quality data to ensure safe and effective health products. It is often argued that greater access to individual patient data collections stored in hospitals’ medical records systems may considerably advance medical science and improve patient care. However, as public and private actors attempt to gain access to such high-quality data to train their advanced algorithms, a number of sensitive ethical and legal aspects also need to be carefully considered. Besides giving rise to safety, antitrust, trade secrets, and intellectual property issues, such practices have resulted in serious concerns with regard to patient privacy, confidentiality, and the commitments made to patients via appropriate informed consent processes.

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Why Race-Based Health Disparities Have Little to do With Genetics

By Jonathan Kahn

In a recent article in Wired, science journalist Angela Saini discusses “the disturbing return of scientific racism.” The piece is drawn from her new book, “Superior: The Return of Race Science.” Scientific racism per se might be succinctly characterized as (mis)using science to assert essential biological bases for differences among socially defined racial groups. It has been used over 200 years to justify, and indeed promote, the subordination of certain racial groups as purportedly inferior to others.

Saini does an admirable job of tracing the roots of modern scientific racism and identifying its resurgence. Her story in the Wired piece, however, focuses primarily on the more obviously pernicious manifestations of scientific racism exemplified by Bruce Lahn’s work at the University of Chicago asserting a genetic basis for cognitive differences across socially defined racial groups. Saini effectively shows how other geneticists and social scientists dismantled these claims but frames its appeal in the widely held mistaken belief that “races have natural genetic propensities.”

The dangers of scientific racism, however, manifest not only in pernicious attempts to show superiority of inferiority among races. They also emerge more subtly and complexly in the well-meaning work of biomedical professionals seeking to explore broader racial differences, particularly in the field of health disparities. Read More

Image of a pile of contraceptive pills.

The Contraceptive Mandate Takes Another Hit  

By Elizabeth Sepper and John Aloysius Cogan, Jr.

Known for his national injunctions of federal legislation, district court judge Reed O’Connor is at it again. In DeOtte v. Azar [PDF], he issued a permanent injunction granting religious exemptions to two nationwide classes that object to the Affordable Care Act’s contraception mandate. Judge O’Connor’s decision is notable for both its expansion of religious exemptions—in contradiction of eight out of nine appellate courts to consider the issue—and its casual disregard for the realities of health insurance markets.

DeOtte is the latest in a series of lawsuits pitting the Religious Freedom Restoration Act, which bars the federal government from substantially burdening a person’s exercise of religion, against the ACA’s mandate that insurance plans cover FDA-approved contraceptives.

Initially, under the mandate, churches were exempt and religious non-profit employers—like hospitals and universities—received an accommodation. So long as non-profits gave notice of their objection, their plans could exclude contraception. Their employees then would receive contraception coverage through the insurance company or health plan administrator. In 2014, the Supreme Court extended the accommodation to closely held for-profit corporations in Burwell v. Hobby Lobby, Inc. Read More

When It Comes to Abortion Restrictions, State Legislatures Try Fighting Fire with Fire  

By Adrienne R. Ghorashi

After what seemed like a barrage of legislative attacks on abortion rights last monthsome states are hitting back by strengthening their laws to protect the right to an abortion. Illinois, Maine, Nevada, New Jersey, New York, Rhode Island, and Vermont have all passed legislation this year expanding access to abortion in various waysIn the current political climatewhere some fear that Roe v. Wade is in danger of being gutted or overturnedstate legislatures are a key battleground in the abortion fightLegislatures and courts alike have been testing the very limits of the constitutional protections cemented in RoeAs deference to Roe wavers in the courts, enacting proactive legislation is a strategy that advocates of abortion access are paying close attention to  Read More

Cover of the book "Transparency in health and health care in the US"

Order Now: “Transparency in Health and Health Care in the United States”

Transparency is a concept that is becoming increasingly lauded as a solution to a host of problems in the American health care system. Transparency initiatives show great promise, including empowering patients and other stakeholders to make more efficient decisions, improve resource allocation, and better regulate the health care industry.

Nevertheless, transparency is not a cure-all for the problems facing the modern health care system. The authors of this volume present a nuanced view of transparency, exploring ways in which transparency has succeeded and ways in which transparency initiatives have room for improvement. Read More

Laboratory IVF petri dish under a microscope.

Fertility Fraud: Major Developments in Texas, Idaho, and Indiana

By Jody Lyneé Madeira

Spring of 2019 brought flowers, showers…and many updates on the “fertility fraud” front.

Perhaps the biggest developments are on the legislative front. On May 5, Indiana Governor Eric Holcomb signed Senate Bill 174 into law, creating civil and criminal causes of action for fertility fraud for former patients and their offspring (and donors whose gametes were used in an unconsented-to manner).

Plaintiffs who sue in tort can be reimbursed for the costs of the fertility procedure and $10,000 in damages. The act makes it a level 6 felony to make a misrepresentation involving human reproductive material and a medical procedure, medical device, or drug. Read More

Are Wellness-Based Insurance Products Really a Win For Everyone?

By Anya Prince 

Insurers have long been in the business of selling a variety of life insurance products to their customers, but a new trend has them promoting wellness and encouraging customers to make healthy lifestyle choices through benefits programs. John Hancock’s Vitality program, for example, offers customers a free Fitbit, savings on annual life insurance premiums, and other discounts and perks for meeting fitness goals.

Other insurers are joining in this wellness game, offering their own versions of incentives and access to wearables in exchange for fitness goals. At first blush, these programs are a classic win-win situation similar to that behind workplace wellness programs. Customers/employees get free wearables. Win! Customers/employees (ideally) live longer due to healthy lifestyle choices. Win! Life insurers/employers have customers that pay premiums for more years before they die and a claim is paid out. Win!  Read More