Thursday, September 4, 2014
The HealthLawProf Blog would like to welcome guest blogger Assistant Professor Jennifer Brobst. Here is her short bio:
Jennifer A. Brobst is an Assistant Professor and the new Director of the Center for Health Law and Policy at Southern Illinois University School of Law, which has an emphasis in rural health law and an award-winning medical-legal partnership program. She is transitioning into the role with the generous partnership and support of the former Director and founder of the Center, Prof. W. Eugene Basanta, who is retiring. Prof. Brobst comes to SIU from a clinical faculty position at North Carolina Central University School of Law, where she served for eight years as the Legal Director of the Center for Child and Family Health in Durham, North Carolina. The Center for Child and Family Health is an interdisciplinary non-profit medical-legal partnership, focusing on treatment for child traumatic stress and best practices in abuse prevention, with a consortium of psychiatry, social work and pediatric medicine faculty from Duke University, University of North Carolina at Chapel Hill, and North Carolina Central University (NCCU). She previously served as the first Clinical Supervising Attorney for the NCCU Domestic Violence Clinic, and has a strong experiential focus in nonprofit and government victims rights work. She received her B.A. from the University of Cape Town, Republic of South Africa (1991) (Social Anthropology and Archaeology), J.D. from the University of San Diego (1996), and LL.M. from Victoria University in Wellington, New Zealand (2001). Her scholarship and national presentations have focused on international comparative child abuse laws in British Commonwealth nations, American fetal homicide laws, attorney mental health and ethics, expert witness testimony, and government transparency and Sunshine laws. She is the author of the annually revised deskbook Admissibility of Evidence in North Carolina, in the North Carolina Practice Series by Thomson Reuters. Prof. Brobst teaches courses in Public Health Law, Scientific Evidence, Professional Responsibility, Criminal Law, Evidence, Domestic Violence Law, Mental Health Law, and Children and the Law.
Cross-Posted from Bill of Health
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.
On a slightly different note the final HealthKit guideline is as follows: “ Apps that provide diagnoses, treatment advice, or control hardware designed to diagnose or treat medical conditions that do not provide written regulatory approval upon request will be rejected.” If that language seems somewhat familiar it is because it tracks some of the wording of the FDA’s 2013 Guidance on Mobile Medical Applications as to apps that will be subject to medical device regulation.
It has not been a great privacy/security week for Apple. The ‘celebrity data’ brute force attack should lead us all to improve our passwords and adopt two-step verification, but the popular press narrative will continue to inaccurately suggest that Apple’s iCloud was hacked. Next week when the Apple faithful congregate in the big white box that has been constructed at the Flint Center, don’t be surprised if the rigor of Apple’s HealthKit guidelines receive particular emphasis.
Wednesday, September 3, 2014
West Virginia University College of Law is seeking candidates with outstanding credentials in the area of Healthcare Law and related courses (tenure-track/tenure). Candidates for this position should have expertise in health disparities, public health, and the Affordable Care Act, and be willing to conduct research with a team of public healthcare experts at WVU.
Please address letters to Appointments Committee Co-Chair Robert Bastress c/o Toni Sebree, West Virginia University College of Law, P.O. Box 6130, Morgantown, WV 26506-6130.
Friday, August 29, 2014
Cross-Posted from Bill of Health
On September 9 Apple is hosting its ‘Wish We Could Say More’ event. In the interim we will be deluged with usually uninformed speculation about the new iPhone, an iWatch wearable, and who knows what else. What we do know, because Apple announced it back in June, is that iOS 8, Apple’s mobile operating system will include an App called ‘Health’ (backed by a ‘HealthKit’ API) that will aggregate health and fitness data from the iPhone’s own internal sensors, 3rd party wearables, and EMRs.
What has been less than clear is how the privacy of this data is to be protected. There is some low hanging legal fruit. For example, when Apple partners with the Mayo Clinic or EMR manufacturers to make EMR data available from covered entities they are squarely within the HIPAA Privacy and Security Rules triggering the requirements for Business Associate Agreements, etc.
But what of the health data being collected by the Apple health data aggregator or other apps that lies outside of protected HIPAA space? Fitness and health data picked up by apps and stored on the phone or on an app developer’s analytic cloud fails the HIPAA applicability test, yet may be as sensitive as anything stored on a hospital server (as I have argued elsewhere). HIPAA may not apply but this is not a completely unregulated area. The FTC is more aggressively policing the health data space and is paying particular attention to deviance from stated privacy policies by app developers. The FTC also enforces a narrow and oft-forgotten part of HIPAA that applies a breach notification rule to non-covered entity PHR vendors, some of whom no doubt will be selling their wares on the app store.
As health data has migrated from conventional health care providers these gaps in our health privacy laws have become quite evident yet Congress has failed to react (Senator Schumer’s FitBit “privacy nightmare” aside). Apple now looks like it is going to fill the privacy vacuum with some serious private ordering. According to various reports from theFinancial Times and the Guardian Apple has amended its developer contracts to include strong mHealth privacy protections.
Outright provisions such as “must not sell an end-user’s health information collected through the HealthKit APIs to advertising platforms, data brokers or information resellers” are coupled with proportionality rules (long missing from U.S. privacy) such as “You and your application may not use the HealthKit APIs, or any information obtained through the HealthKit APIs, for any purpose other than providing health and/or fitness services in connection with your application (e.g. not for serving advertising).” There is even a medical research exception that is dependent on user consent (hopefully, a context specific opt-in).
‘Wish We Could Say More’ probably doesn’t refer to ‘Health,” but it may allude to the new privacy world surrounding Apple’s apps—developers are going to be severely constrained as to what more they can say and distribute with regard to patient health data. Lets hope the other platform developers (Samsung, Google, etc.) take notice or, if not, that smartphone buyers will express their desire for health privacy with their wallets.
Thursday, August 28, 2014
Reversing its previous deference to corporate speech interests, the U.S. Court of Appeals for the D.C. Circuit came down in favor of consumer protection in a July 29 decision. In American Meat Institute v. U.S. Dept. of Agriculture, the court upheld a federal government regulation requiring meat companies to disclose the countries of origin for their products. If your beef comes from Argentina or Canada, you will know that from its label.
More importantly, the court gave the Food and Drug Administration greater freedom to reduce tobacco use in the United States. In explaining its reasoning, the court repudiated the logic of an earlier decision by the court that rejected the FDA’s graphic warnings for cigarette packs. According to the meat labeling opinion, the cigarette warning decision did not allow sufficient leeway for the government to mandate warnings or other informational disclosures to consumers.
Perhaps the U.S. Supreme Court will restore the D.C. Circuit’s previous balance, but for now, the tide has turned in favor of the public’s health.
Wednesday, August 27, 2014
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch: Bioethics Fact and Fiction in Lifetime’s The Lottery
(Warning: this post discusses the pilot episode of the Lottery, a show that debuted on Lifetime in mid-July. If you want to be surprised by the basic plot elements of the show, perhaps hold off on reading this…).
I have a weakness for shows that feature bioethical inquiries in their plot lines. Orphan Black, on BBC America, highlights cloning and patenting of human genes. And now the Lottery is based in the not-too-distant future, where all women are infertile. Six years after the last child was born and after incredible amounts of time and money spent trying to find an infertility “cure,” scientists successfully create 100 embryos from donated gametes. So the decision must be made: who will carry these embryos?
Rhetoric that misconstrues scientific knowledge to garner support for political positions is troubling. For many years, my scholarship has focused on the debate surrounding embryonic stem cell research. One of the things that I have experienced is an incomplete understanding about what embryonic stem cell research is, what the starting material is, and why it might be different than adult stem cells. One reason that the public may be confused is because some of the information fed to the public is incomplete or, even, incorrect.
To understand the type of information that the public receives regarding a controversial type of research, in this case, embryonic stem cell research, I conducted an empirical study. By way of background, in 2001, an intense debate about the federal funding for stem cell research occurred. One of the arguments against federal funding for stem cell research was that there was no need for it because scientists could use adult stem cells (which didn’t have the same ethical concerns) instead of embryonic stem cells. The problem with this proposition, however, was that it had no scientific merit because the scientists had not yet conducted the studies to compare human adult and embryonic stem cells. The call for the need for these studies was loud and clear in the scientific community. But, it seemed that some in the non-scientific community already came to the conclusion that these cell types were interchangeable.
Friday, August 22, 2014
Nice article in today's New York Times describing a hospital redesign that was followed by marked improvements in patient satisfaction--and a 30 percent reduction in requests for pain medication. From my medical practice days, I remember the adage that hospitals are designed for doctors rather than patients. It's heartening to see that priorities are changing.
Kevin Outterson has posted a link to the American Health Lawyers Association guidance for health law classes and programs. Kevin worked hard with others at AHLA to turn practitioners' suggestions into a useful document. At the very least, food for thought.
Tuesday, August 19, 2014
HealthLawProf Blog would like to thank our wonderful July guest blogger Professor Leslie E. Wolf. Here is a short recap of her posts:
Professor Leslie E. Wolf posted the following: Lessons from the Facebook “Emotional Contagion” Experiment, Public Health: Victim Of Its Own Success
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch: How an Obligation to Return Research Results Is (and Should be) Changing the Investigator-Participant Relationship
Technological advances, such as whole genome or exome sequencing, are changing the nature of research protocols. With these advances, the discovery of incidental or secondary findings (“research findings”) – or other information that could affect the research participant’s health or decision-making – will become more likely and frequent. Whether there is an ethical duty to disclose the results of research to individual participants – regardless of whether the results are directly related to the central research inquiry – has consequently become a central question in human subjects research.
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch: Ventilator Allocation in a Pandemic
In 2014, the New York State Task Force on Life and the Law, the state’s bioethics commission, will release its updated Allocation of Ventilators in an Influenza Pandemic, which enunciate a comprehensive clinical and ethical framework to guide distribution of ventilators in the event of a severe public health emergency using objective medical criteria, with the ultimate goal of saving the most lives. These guidelines are the product of seven years of hard work by the Task Force and its staff and were developed by incorporating comments, critiques, feedback, and values from numerous stakeholders. They draw upon the expertise of multiple workgroups and committees with special knowledge in scarce resource allocation, pediatric and neonatal medicine, ethics, law, and policy. The 2014 version of these guidelines will not only include an updated clinical protocol for allocation of ventilators to adults; they will also include first of their kind protocols for allocation of ventilators to two important and previously unaddressed segments of the population: pediatric patients and neonates.
Guest Blogger Associate Dean and Associate Professor Joanna K. Sax: The Regulation of Dietary Supplements
How have the massive amounts of dietary supplements on the market evaded significant regulatory oversight for so long? Dietary supplements are regulated as food, which means that for practical purposes the FDA only has the ability to pull them off the shelves upon a showing that they are harmful.
Many consumers use dietary supplements for the same purposes that someone may use a non-prescription drug. Some consumers actually feel safer using a dietary supplement because it is labeled as “natural,” rather than using an FDA approved over-the-counter drug. This doesn’t and shouldn’t make sense. Many natural things are harmful – would you eat any wild mushroom? Tobacco in in cigarettes is natural. Just because something is natural doesn’t mean that it is safe. Conversely, just because something isn’t “natural” in a drug doesn’t mean it is unsafe.
Thursday, August 14, 2014
Biolaw section of the Association of American Law Schools (AALS)
Monday, January 5, 2015, 10:30 a.m. to 12:15 p.m.
The 2014 west African outbreak of the Ebola virus is the most severe epidemic attributed to this pathogen since 1976, when international health officials began keeping records on Ebola. As of August 2014, the total number of suspected cases has approached 2,000, and the number of suspected deaths has exceeded 1,000. The World Health Organization has designated the health crisis as one of international concern. The law has a strong stake in containing this outbreak and preventing future episodes of this kind.
The Biolaw section of the AALS invites papers addressing issues of law and policy arising from the Ebola outbreak. Such issues may include (but by no means are limited to) the following:
- Why was the international legal and public health community so slow to recognize the 2014 Ebola outbreak? Human beings are supremely attuned to threats posed by other humans (such as war or terrorism), but far less prepared for threats deemed "natural" or "environmental." How should law accommodate and/or offset this biological predisposition?
Wednesday, August 13, 2014
It probably depends on who you ask. Proponents of fracking laud the energy independence, creation of jobs, environmentally friendly nature of natural gas, national security and economic benefits. Opponents to fracking have concerns about the impact to the environment, public health issues, and water use. Each side dismisses the other side’s arguments.
Perhaps a primer on hydraulic fracturing, known as fracking, is helpful. Fracking is the process of creating long vertical wells below the earth’s surface and then horizontal wells that break open the shale and allow the natural gas to be released and captured. Fracking uses millions of gallons of water to create these wells. A proprietary mix of chemicals in the water is used to create the fissures in the shale. Since the shale is far below the surface, proponents of fracking were able to convince Congress to exempt the industry from the Safe Water Drinking Act, which is now affectionately called the Halliburton Loophole.
The problem with assessing proponents and opponents positions on fracking is the lack of scientific data. While it may be true that the fracking wells are far below the surface, leaks in the fracking wells could impact the aquifers. The EPA is conducting a large scale drinking water impact study, with results that are eagerly anticipated to be released later this year. It could be that, for example, drinking water is/has been contaminated, but that with new regulations and novel innovations, these wells could be made safe such that drinking water is not contaminated. But, we don’t know if there is a problem without the scientific studies and if there is a problem, we need to determine if science/innovation can address the problem.
Tuesday, August 12, 2014
Theodore M. Hammett, Son H. Phan, Julia Gaggin, Patricia Case, Nicholas Zaller, Alexandra Lutnick, Alex H. Kral, Ekaterina V. Fedorova, Robert Heimer, Will Small, Robin A. Pollini, Leo Beletsky, Carl Latkin, Don C. Des Jarlais, Pharmacies as Providers of Expanded Health Services for People Who Inject Drugs: A Review of Laws, Policies, and Barriers in Six Countries, 14 BMC Health Services Res. (2014).
Cathryn Miller-Wilson, Medical-Legal Partnerships: Origins and Ethical Lessons, 93.3 Neb. L. Rev. (Forthcoming 2015).
E. H. Morreim, In-House Conflict Resolution Processes: Health Lawyers as Problem-Solvers, 25 The Health Lawyer 10 (2014).
Jonathan D. Kahn, Privatizing Biomedical Citizenship: Risk, Duty, and Potential in Circle of Pharmaceutical Life, 15 Minn. J. of Law, Sci. & Tech. 791 (2014).
From the ASLME Insider:
The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP New Scholars Workshop on May 7, 2015 at Boston University School of Law.
The Workshop will offer a unique opportunity for three new scholars (in their first decade of teaching) to present their draft scholarship for in-depth critique and commentary by respected senior scholars in the field.