The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.
2017 Petrie-Flom Center Annual Open House September 13, 2017 5:30 PM HLS Pub, Wasserstein Hall, 1st floor Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Join faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics … Continue reading
The Neurolaw Revolution: A lecture by Francis X. Shen September 13, 2017 4:00 PM Wasserstein Hall, Milstein East A (2036) Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Rapid advances in the brain sciences offer both promise and peril for … Continue reading
The week of Sept. 4-11, 2017 brought more housing-related news from the southeast in the wake of Harvey and Irma, and a few new resources. The latest in housing equity and the law, below: Matthew Desmond writes a Housing State … Continue reading
September 11, 2017, 5-7 PM Hauser Hall, Room 104 Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA Download the Presentation: “Fracking Health Care: The Need to Safely De-Medicalize America and Recover Trapped Value for Its People” William M. Sage is James R. Dougherty Chair … Continue reading
by Alix Masters
Within the last decade, strides have been made in the field of global health policy to extend the reaches of palliative care universally. In 2014, the World Health Organization formally declared palliative care a global human right. This development in global health policy is a positive one when we consider the medical politics of pain relief across racial difference. Both in the United States and abroad, there is a long medical history of discriminatory practices against certain groups of people with regard to pain management—including withholding necessary pain medication altogether. Therefore, in many ways the declaration of palliative care as a human right is a necessary step in ensuring all peoples, regardless of identity, have their pain taken seriously by the medical establishment and have their comfort made a medical priority. When we consider how different cultures negotiate beliefs around death and pain relief, however, the issue of palliative care as a universal human right becomes more complex. For example, countries with strong histories of Buddhist thought and culture have traditionally opposed the ideology of palliative care. In Buddhism, suffering is considered an inextricable part of life and masking this suffering through medical intervention is looked down upon. For example, Vietnam, a country with a culture strongly imbued with Eastern Buddhist values, has a long history of rejecting palliative care and pain medications in general. Due to this, the World Health Organization’ declaration that palliative care is a universal human right could also be understood as a Western organization blatantly ignoring Buddhist cultural traditions.
By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! We talk with Lewis A. Grossman, a professor of law at American University and Of Counsel at Covington & Burling. Lewis is on sabbatical during academic year 2017-18, serving as a Law and Public Affairs (LAPA) Fellow at Princeton University. … Continue reading
The Petrie-Flom Center is pleased to welcome our new 2017-2018 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be … Continue reading
by Craig Klugman, Ph.D.
This is a time of disaster. Last week Hurricane Harvey devastated Southeast Texas, a place where I did my doctoral studies. This week we are awaiting Hurricane Irma, the strongest hurricane to head toward South Florida in 25 years. My family lays in the path of that coming storm. I first became interested in natural disaster in 1989 when my college campus was jolted by a 7.1 earthquake in Northern California.
Bioethics has a role in responding to and preparing for these natural disasters. Most every state, large city and county, and most hospitals have been working on crisis standards of care plans. In 2009 and again in 2012, the Institute of Medicine recommended governments to undertake such planning. Many of us working in bioethics have been involved in these efforts. More specifically, we have been involved with developing ethical frameworks for decision-making, policy-making, and operations during emergency planning.
I worked with Texas during its planning for pandemic flu and for the last 3 years have been part of the ethics subcommittee of Illinois’ workgroup, most recently as chair. Similar groups have produced excellent reports in many places such as Delaware, North Carolina, Michigan, Minnesota, Tennessee, Texas and Toronto. They offer guidance and justification for a varied set of guiding principles and ethical frameworks. All of them hold certain core ideals in common.
First, all of the reports agree that transparency and open communication is essential. Planning needs to involve not only government officials, but also community members.
FDA should regulate digital games, and potentially other apps, as medical devices.
Why, pray tell?
One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting. CBS has been on the story since at least 2007. In 2014, “60 minutes” suggested that a violent video game could prompt murder. Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?” And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use. They revisited the topic, with the same interviewee, in June, using the term “brain hacking.” Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.
Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new. Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?
The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.
According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):
- “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”