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

Innovation Gaps on Life Science Frontiers

Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The  Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).

Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.

Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)

Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K

More information on  speakers, agenda and registration is available here and here.

Extended background:

Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.

To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.

This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.

 

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Colorado Supreme Court Hears Important Case Re Constitutional Issues on Dispute About Frozen Preembyros – My Take on Oral Argument

By I. Glenn Cohen

On Tuesday, January 9th, the Colorado Supreme Court heard oral argument in In Re Marriage of Rooks. (Kudos to them for live streaming and archiving!)

This is the latest of a series of cases involving disputes between ex husbands and ex wives (or in some cases unmarried former partners) regarding the disposition of cryopreserved pre-embryos. These cases, that have been percolating in a large number of states for what has now been 25 years (!) and have come out in a myriad of ways on a myriad of theories as Eli Adashi and I recently detailed in the Hastings Center Report.

One thing many of these cases have in common, though, is that the Courts have avoided reaching the fundamental federal Constitutional question I wrote about now 10 years ago in the Stanford Law Review: Does the party opposing the implantation of embryos upon dissolution of the marriage have a right not to procreate recognized by the federal Constitution? I have argued that we need to realize we are talking about possible rights (plural) not to procreate and in particular separate out:

The right to be a gestational parent The right not to be a gestational parent
The right to be a genetic parent The right not to be a genetic parent
The right to be legal parent The right not to be a legal parent.

This case demonstrates well why such a distinction is important.

Read More