This is the first of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.
This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.
By Prof. I. Glenn Cohen and Kaitlyn Dowling
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is excited to host the Eighth Annual Health Law Year in P/Review to be held at Harvard Law School December 6, 2019. This one-day conference is free and open to the public and will convene leading experts across health law policy, health sciences, technology, and ethics to discuss major developments in the field over the past year and invites them to contemplate what 2020 may hold. This year’s event will focus on developments in health information technology, the challenge of increasing health care coverage, immigration, the 2020 election, gene editing, and drug pricing, among other topic areas.
As we come to the end of another year in health law, the event will give us both a post-mortem on the biggest trends in 2019 and also some predictions on what’s to come in 2020.
Among the topics we will discuss: Read More
By I. Glenn Cohen
As has been well reported in the media, there is a controversy brewing over nonprofit hospital chain Ascension sharing millions of patient records with Google for their project codenamed “Nightingale.” (very Batman, if you ask me!) Most of the discussion so far, and the answers have not yet become pellucid, concerns whether the hospital and Google complied with HIPAA.
This is important, don’t get me wrong, but it is important that conversation not ignore a more important question: Read More
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.
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 Fox, Eli 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
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
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
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
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