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.
Tuesday, August 5, 2014
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch - FDA Announces Plans to Regulate LDTs (But What About DTC Genetic Tests?)
Oversight of direct-to-consumer (DTC) genetic tests and laboratory developed tests (LDTs) in general has garnered increasing attention in the media. Most recently, on July 31, pursuant to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA notified Congress that it intends to issue draft guidance for the oversight of LDTs – diagnostic tests (including genetic tests and tests for rare conditions) developed and performed by a single laboratory. The FDASIA requires the FDA to provide at least 60 days’ notice before publishing any draft guidance on the regulation of LDTs.
FDA’s decision to exercise its jurisdiction over LDTs as medical devices has been discussed and even expected for almost a decade. In June 2013 FDA Commissioner Margaret Hamburg called for more active FDA regulation of LDTs, stating that the Agency’s risk-based framework for regulating such tests was under development. Hamburg noted that the FDA has discretion in overseeing certain LDTs as devices. Although historically “they were relatively simple, low-risk tests performed on a few patients being evaluated by physicians at the same facility as the lab,” she explained that they now warrant oversight because they have become “more sophisticated and complex.”
HealthLawProf Blog is very pleased to welcome the second of our bloggers for the month of August, Visiting Assistant Professor Valerie Gutmann Koch. The following is her short bio:
Valerie Gutmann Koch is Visiting Assistant Professor at IIT Chicago-Kent College of Law and Lecturer in Law, Medicine, and Ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She also serves as Special Advisor to the New York State Task Force on Life and the Law, the state’s bioethics commission; she previously served as the Senior Attorney to the Task Force. Professor Koch's research interests focus on the issues arising at the intersection of law, medicine, and ethics, with a focus on emerging technologies in medicine and science and the legal challenges they pose. Previously, she practiced in the IP litigation practice at Kirkland & Ellis LLP. Professor Koch received her Juris Doctor from Harvard Law School, and she graduated magna cum laude with an A.B. from Princeton University's Woodrow Wilson School of International Affairs and Public Policy. Her recent research can be found on SSRN.
I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.
The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.
But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.