- James C. Robinson, Biomedical Innovation In The Era Of Health Care Spending Constraints, Health Affairs
- Susan M. Wolf et al, Forty Years of Work on End-of-Life Care — From Patients’ Rights to Systemic Reform, NEJM
- Leslie P. Francis, Patient Registries: Patient Consent When Children Become Adults, SSRN/SLU JHLP
- Eric S. Lander, Cutting the Gordian Helix — Regulating Genomic Testing in the Era of Precision Medicine, NEJM
- Lawrence O. Gostin, Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak, JAMA
Category: Health Law Policy
Youth Sports at a Crossroads (and Project Play Summit streaming today 2/25)
By: Christine Baugh
Youth sports participation comes with a variety of health and social benefits. The position statement put out by the American Medical Society for Sports Medicine (AMSSM) indicates that over 27 million individuals age 8-17 participate in team sports in the United States, and over 60 million participate in some form of organized athletic activity. These youth and adolescent athletes benefit from better overall health as well as increased socialization and self-esteem. However, a recent report by the Aspen Institute’s Project Play Initiative indicates that there has been a significant decline in sports participation in recent years.
One factor influencing the decrease in participation may be parental concerns. A recent survey of parents conducted jointly by ESPNw and the Aspen Institute characterized these concerns finding a large percentage of parents were worried about the risk of injury, behavior of coaches, cost, time commitment, and the emphasis on winning over having fun. Concussions and head injuries were the most worrisome injury for parents in this study. Despite this concern, very few parents reported keeping their child from participating in sports due to this risk. The AMSSM position statement characterizes the preoccupation with specialization and competition within sports at such a young age as a risk factor for injury and burnout. Read More
‘The Week in Health Law’ Podcast
Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.
Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.
This week, a special treat, as we are joined by Nicole Huberfeld to discuss Medicaid expansion (as well as Google health searches and bending the safety curve).
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale
NEXT WEEK (3/4): The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility
The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility
Wednesday, March 4, 2015
12:00 PM
Wasserstein Hall, Room 3019
Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA 02138
Do criminal penalties have any deterrent effect on drug addicts – people who already are willing to throw away their jobs, relationships, or even lives for their “fix”? What does brain science tell us about addicts’ capacities to exert self control and to be held criminally responsible? This panel discussion brings together a leading neuroscientist of addiction, a criminal law scholar, and a former judge to ask whether the law should reconsider aspects of responsibility and punishment in light of new science about self-control.
Panelists:
- Joshua Buckholtz, Assistant Professor, Harvard University Department of Psychology
- Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience, Petrie-Flom Center/Center for Law Brain and Behavior, and Associate Professor of Law at the University of Maryland School of Law
- Judge Nancy Gertner, Senior Lecturer on Law, Harvard Law School
Part of the Project on Law and Applied Neuroscience.
Doctors Conducting Peer Review Can Recover Compensatory and Punitive Damages for Confidentiality Violations
By Alex Stein
The Supreme Court of New Mexico has recently delivered an important decision protecting peer reviewers’ statutory entitlement to confidentiality. Yedidag v. Roswell Clinic Corp., — P.3d —- (N.M. 2015), 2015 WL 691333. The Court ruled that peer reviewers can sue violators of their confidentiality right and recover compensatory and even punitive damages. This ruling applied the common law criteria for identifying statutory violations as a breach of contract. Based on those criteria, the Court categorized peer reviewers as members of the class protected by the peer review statute, who deserve remedies for violations of their confidentiality right. The Court also estimated that the criminal penalty imposed by the statute on the right’s violators was too lenient to discourage violations. The Court projected that allowing peer reviewers to sue violators will compensate for the resulting shortfall in deterrence. As a conceptual matter, the Court decided that peer reviewers’ confidentiality entitlement is a “mandatory rule of law incorporated into physician-reviewer employment contracts.” Read More
Monday 2/23: HLS Health Law Workshop with Amy Kapczynski
HLS Health Law Workshop: Amy Kapczynski
February 23, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]
Professor Kapczynski’s presentation, “Order Without Intellectual Property Law: The Flu Network as a Case Study in Open Science,” is available upon request. Please contact Jennifer Minnich (jminnich@law.harvard.edu) if you would like a copy.
Amy Kapczynski is an Associate Professor of Law at Yale Law School and director of the Global Health Justice Partnership. She joined the Yale Law faculty in January 2012. Her areas of research including information policy, intellectual property law, international law, and global health. Prior to coming to Yale, she taught at the University of California, Berkeley, School of Law. She also served as a law clerk to Justices Sandra Day O’Connor and Stephen G. Breyer at the U.S. Supreme Court, and to Judge Guido Calabresi on the U.S. Court of Appeals for the Second Circuit. She received her A.B. from Princeton University, M. Phil. from Cambridge University, M.A. from Queen Mary and Westfield College at University of London, and J.D. from Yale Law School.
In Regulating E-Cigarettes, No Easy Fix For The FDA
This new post by Wendy Parmet appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.
Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.
By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.
Read the full post here.
Check out the latest news from the Petrie-Flom Center!
Check out the February 20th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
Featured in this edition:
FREE REGISTRATION!
Families Matter: Ethically, Legally, and Clinically
March 18 – 20, 2015
Harvard Medical School
Boston, MA
We often talk, in bioethics, about individual autonomy. Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children? What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members? What weight should be given to family interests in decisions about a child’s health care? How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring? Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter. Read More
Problems with fMRI as a tool of lie detection
by Zachary Shapiro
Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.
Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings.[1] In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.
Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community.[2] Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.
Dying: Closing the Gap between What We Know & What We Do
By Susan M. Wolf, JD (University of Minnesota), Nancy Berlinger, PhD (The Hastings Center), and Bruce Jennings, MA (Center for Humans and Nature)
Time is running out on fixing the way we die. As readers of this blog know, the courts first declared a right to refuse unwanted life-sustaining treatment in the 1976 Quinlan case. Nearly 4 decades later, too many people are still burdened with treatments they don’t want, can’t get support for care at home, and are dying without good relief of pain and suffering. So it was no surprise that the highest court in Canada finally threw in the towel. In its Feb. 6 opinion in Carter v. Canada, the court found people still “suffering intolerably as a result of a grievous and irremediable medical condition.” The court thus recognized a right to physician aid in dying. Canada now has a year to set up a system that will permit the practice while protecting the vulnerable from abuse.
Regardless of your views on physician aid in dying, too large a gap remains between what we know is high-quality care at the end of life and what we actually do to care for dying people. The Feb. 12 issue of the New England Journal of Medicine included four articles on the problem, including our analysis of “Forty Years of Work on End-of-Life Care: From Patients’ Rights to Systemic Reform.” Read More
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