human embryos under a microscope

A Lawsuit Involving an Alabama Man and a Fetus Is Particularly Threatening to Reproductive Rights

Last week Alabama passed the most restrictive abortion law in the country, criminalizing abortion of “any woman known to be pregnant,” with very limited exceptions that do not include rape or incest. But a recent case in Alabama presents an even more threatening challenge to reproductive rights.

In a new paper published in JAMA, the Journal of the American Medical Association, authors Dov FoxEli Y. Adashi, and I. Glenn Cohen, discuss a recent Alabama state court case involving a man suing an abortion clinic and the manufacturer of a pill that enabled his then-girlfriend to terminate her pregnancy at 6 weeks.

In a troubling decision, the court permitted the fetus be a co-plaintiff alongside the man in a “wrongful death” lawsuit. Read More

WATCH: I. Glenn Cohen on ‘The Second Reproductive Revolution’

Dean John F. Manning honored Prof. I. Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, on the occasion of his appointment as the James A. Attwood and Leslie Williams professor of law.

Cohen, who is one of the world’s leading experts on the intersection of bioethics and the law, delivered a talk titled “The Second Reproductive Revolution,” focusing on how technology is changing reproduction from gene editing, to uterus transplants, to embryos derived from our skin. Read More

HIPAA is the Tip of the Iceberg When it Comes to Privacy and Your Medical Data

Big data continues to reshape health. For patient privacy, however, the exponential increase in the amount of data related to patient health raises major ethical and legal challenges.

In a new paper in Nature Medicine, “Privacy in the age of medical big data,” legal and bioethical experts W. Nicholson Price and I. Glenn Cohen examine the ways in which big data challenges the protection (and the way we conceive) of health care privacy. Read More

3 Things You Should Know About the Petrie-Flom Center’s 2019 Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive, and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

We are excited, therefore, to have many major thought leaders in this space discuss these issues at the Petrie-Flom Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies,” which will take place at Harvard Law School in May. Read More

FDA scott gottlieb

How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle

I am a huge fan of FDA Commissioner Scott Gottlieb.

He is by far my favorite Trump appointee — though the competition isn’t tough, to be honest— and he is doing great things at FDA on issues such as mobile health, software, and so on.

But in his comments on the news that gene edited embryos in China had led to live births, I think he has it wrong.

“The response from the scientific community has been far too slow and far too tepid, and the credibility of the community to self-police has already been damaged,” he said to Biocentury. “Governments will now have to react, and that reaction may have to take consideration of the fact that the scientific community failed to convincingly assert, in this case, that certain conduct must simply be judged as over the line.” Read More

Machine Learning in Medicine: Addressing Ethical Challenges

Machine learning in medicine is accelerating at an incredible rate, bringing a new era of ethical and regulatory challenges to the clinic.

In a new paper published in PLOS Medicine, Effy Vayena, Alessandro Blasimme, and I. Glenn Cohen spell out these ethical challenges and offer suggestions for how Institutional Review Boards (IRBs), medical practitioners, and developers can ethically deploy machine learning in medicine (MLm). Read More

Investigating Conflicts of Interest in Patient-Centered Outcomes Research

By I. Glenn Cohen

The Patient Centered Outcomes Research Institute (PCORI) was established under the Affordable Care Act. Its goal is to fund and encourage Patient-Centered Outcomes Research (PCOR), understood as evaluating questions and outcomes that are meaningful not just to researchers, but to patients and caregivers as well.

One key way of achieving this is to involve patients as personnel in research projects as advisors, consultants, or team members involved in any aspect of research, from topic development through study design, implementation, interpretation, and dissemination.

But where do these patients come from? How representative are they of the patients who will ultimately participate in the study?

Read More

New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University: Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility.

The article, written by the Law and Ethics Initiative of the Football Players Health Study at Harvard University, examines whether the U.S. Occupational Safety and Health Administration (OSHA) should take an active role in improving health and safety in the NFL workplace.

The article concludes that while OSHA clearly has the authority to regulate the NFL, there is little to no precedent or guidance for OSHA to insert itself into the on-the-field aspects of professional sports. The small body of case law that bears on OSHA’s authority in entertainment and sports opens some doors for OSHA to issue standards for the NFL but also sets some limits on its ability to alter the nature of the game. Adding a public institution like OSHA as a party to existing labor-management discussions concerning health and safety may be the best natural evolution of the issue, the report says, mapping a pathway for OSHA to step up to this challenge. Read More

Should courts treat destroyed embryos as “lost property” or “wrongful death”?

Bill of Health contributors Glenn Cohen and Dov Fox were featured in this week’s news coverage of novel claims related to recent freezer malfunctions at two major fertility clinics. A class-action suit by one Ohio couple who lost their embryos asks the court to afford embryos standing to use and declare that life begins at conception.Friday’s article asks: “Will Fertility Clinic Disaster Redefine Personhood?” From the piece:

Roe v. Wade made it clear that an embryo or fetus is not a person under the protections of constitutional and federal law. Since then, no [Supreme Court] ju[stices] have suggested otherwise, Dov Fox, a law professor at the University of San Diego, told The Daily Beast. That doesn’t mean that wrongful death claims cannot be filed on behalf of a fetus [or that] the fetus has legal standing as a person overall, but wrongful death can be brought on its behalf—”for lack of a better legal fiction,” Fox said.

Fox added that in similar cases dealing with the loss of embryos due to hospital or clinic in the past, the courts decide that an embryo is not a person for the purposes of wrongful death cases. He pointed to two cases where embryos were damaged—one in Arizona in 2005, and one in Illinois in 2008. Both held that the wrongful death statutes do not apply to the loss of an embryo that hasn’t yet been implanted in a womb. Therefore, it would be surprising if the Ohio court ruled differently. “It would fly in the face of all existing legal precedent,” Fox said. Read More