Month: September 2014

The FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

The Petrie-Flom Center Staff Leave a comment

By Rachel Sachs

[Note: I am very pleased to have had the opportunity to write a response to a recent commentary posted on the Hastings Center Bioethics Forum about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs), an issue I have previously written about for this blog. My response, which is posted here at the Bioethics Forum, is cross-posted below.]

Wendy Chung’s commentary last month about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs) is heavily critical of the agency’s plans. Professor Chung argues that the FDA’s involvement in this space will have two primary negative consequences: it will stifle innovation and it will harm patient care.

But the FDA’s proposal seems designed to address precisely these two consequences. The proposal could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA’s disclosure to Congress is critical to a full policy discussion of the situation.  Read More

9/18/14: Post-Trial Responsibilities Conference

The Petrie-Flom Center Staff Leave a comment

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave.

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website. 

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

Is “My Patient’s Agent” Always Justified?

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Kelsey Berry

Is a physician always justified in acting as his or her patient’s agent?

This question is familiar to clinical and population-level bioethicists alike, though I hesitate to say that it is age-old. There are a variety of ways to approach a response to this question, as evidenced by extensive treatment of this topic in the philosophical and bioethics literature (which I will not survey here). One popular approach involves raising candidate circumstances that may justify deviations from the principal-agent relationship that obtains between physicians and patients* – for instance, ethicists might consider whether a physician is justified in deviating from acting as his or her patient’s agent under circumstances in which (a) the action that is in the best interest of the patient conflicts with the action that in the best interest of the population health, (b) the action that is in the best interests of the patient requires inefficient use of community resources on some criteria, or (c) what the patient perceives to be in his or her best interests conflicts with what the physician recommends, etc. This list is woefully inexhaustive, but it highlights a theme in this thread of argumentation. In each scenario, we’re invited to accept the initial assumption that the physician is justified, if not all of the time, at least most of the time, in acting as his or her patient’s agent. Then we are led to consider whether the candidate circumstances raised qualify as an exception to this rule.

The often-unarticulated premise, that the physician is typically justified in acting as his or her patient’s agent, is not without philosophical support from several prominent theories. We also have pragmatic reasons to begin with this premise, for there are few specific actors (to whom we can easily point) that compete with the patient for a principal-agent relationship of the type that obtains between a physician and his or her patient. Of course, other patients under care are obvious contenders, as are other potential patients. Though adjudicating between a physician’s obligations to both existing and potential patients raises interesting issues, the conflicts these principal-agent relationships give rise to still trade on the basic assumption that the physician has reason to maintain the basic fiduciary relationship in most circumstances. Read More

Parental Consent for Youth Contact Sports Participation

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As we enter into the fall sports season, it’s unlikely that a week will go by where we don’t hear the current buzzword in sports community: concussion. Whether in reference to an acute player injury, an untimely death, new or ongoing litigation, or rule changes in sport, the athletic community and the public are increasingly aware of the impacts of these brain injuries. Although much of the media attention is directed toward college and professional athletes, youth and high school athletes significantly outnumber their older counterparts and it is thought that they take longer to recover from these injuries.

A recent publication by Mannings and colleagues surveyed 369 parents of 5-15 year old full-contact football players in order to assess the parents’ understanding of concussion (1). Although the study does have limitations, its finding could have important implications. The parents surveyed were often missing critical information about concussions. For example, less than half of parents correctly identified that concussion is a mild traumatic brain injury. Additionally, none of the parents surveyed correctly identified all of the symptoms of concussion queried in the study. Although it is mandated by statute in the majority of states (2) that parents and/or athletes are provided with information about concussions prior to sports participation, the extent to which the information provided (normally in the form of an information sheet) is read, understood, or retained is not well understood.

Sports participation is associated with a myriad of positive physical, psychological, and social outcomes. However, it also comes with the risk of injury, including concussion. For youth and adolescents, parents play a critical role. Most often, children and adolescents rely on parental consent to participate in sports. Given parents’ role as decision-makers, and the finding of Mannings and colleagues, an important ethical issue that needs to be addressed is what level of knowledge should be required for parents to provide informed consent for their child to participate in inherently risky activities such as contact sports?

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Getting Granular with Apple’s mHealth Guidelines

The Petrie-Flom Center Staff Leave a comment

By Nicolas Terry

In a post last week I compared Apple’s new mHealth App store rules with our classic regulatory models. I noted that the ‘Health’ data aggregation app and other apps using the ‘HealthKit’ API that collected, stored or processed health data would seldom be subject to the HIPAA Privacy and Security rules. There will be exceptions, for example, apps linked to EMR data held by covered entities. Equally, the FTC will patrol the space looking for violations of privacy policies and most EMR and PHR apps will be subject to federal notification of breach regulations.

Apple has now publicly released its app store review guidelines for HealthKit and they make for an interesting read. First, it is disappointing that Apple has taken its cue from our dysfunctional health privacy laws and concentrated its regulation on data use, rather than collection. A prohibition on collecting user data other than for the primary purpose of the app would have been welcome. Second, apps using the framework cannot store user data in iCloud (which does not offer a BAA), begging the question where it will be acceptable for such data to be stored. Amazon Web Services? Third, while last week’s leaks are confirmed and there is a strong prohibition on using HealthKit data for advertising or other data-mining purposes, the official text has a squirrelly coda; “other than improving health, medical, and fitness management, or for the purpose of medical research.” This needs to be clarified, as does the choice architecture. Read More

Introducing David Orentlicher

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Orentlicher-ProfileWe’re excited to introduce David Orentlicher as a regular contributor to Bill of Health.

David is Samuel R. Rosen Professor and co-director of the Hall Center for Law and Health at Indiana University Robert H. McKinney School of Law, where he specializes in health care law and constitutional law. He also serves as President-elect of the American Society of Law, Medicine & Ethics. A graduate of Harvard Law School and Harvard Medical School, he previously has taught as a visiting or adjunct professor at Princeton University, University of Chicago Law School, and Northwestern University Medical School. He also was director of the American Medical Association’s division of medical ethics for 6½ years. For six years, he served in the Indiana House of Representatives and drew on his experiences with partisan conflict in publishing Two Presidents Are Better Than One: The Case for a Bipartisan Executive (NYU Press 2013).

Representative Works:  Read More

Harvard Effective Altruism: Nick Bostrom, September 4 at 8 PM

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[This message is from the students at Harvard Effective Altruism.]

Welcome back to school, altruists! I’m happy to announce our first talk of the semester – from philosopher Nick Bostrom. See you there!

Harvard College Effective Altruism presents:
Superintelligence: Paths, Dangers, Strategies
with Nick Bostrom
Director of the Future of Humanity Institute at Oxford University

What happens when machines surpass humans in general intelligence? Will artificial agents save or destroy us? Professor Bostrom will explore these questions, laying the foundation for understanding the future of humanity and intelligent life. Q&A will follow the talk. Copies of Bostrom’s new book – Superintelligence: Paths, Dangers, Strategies – will be available for purchase. RSVP on Facebook.

Thursday, September 4
8 pm
Emerson 105