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. Continue reading
By David Orentlicher
[Ed Note: Cross-posted at HealthLawProfBlog.]
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.
By Deborah Cho
I’m a little late to this discussion, but I want to talk briefly about the ALS Ice Bucket Challenge and how we make our decisions on charitable giving.
I’m sure by now most readers understand the basic concept of the challenge: individuals can choose to either record a video of themselves pouring ice water over their heads or to donate money to the ALS Association (or both — the rules don’t seem to be particularly consistent in application). After the challenge is undertaken, the video is shared on social media or a message is posted announcing that the individual has donated, and then the individual “nominates” others for the challenge.
This challenge has virtually taken over the web in the past couple weeks (perhaps, as one writer commented, because it lets participants “(a) exhibit his altruism publicly and (b) show off how good he looks soaking wet.”), raising over 88 million dollars as of August 26, 2014. As expected, however, the challenge was not without its very vocal critics. Many were opposed to the narcissistic nature of the challenge, while others, more relevantly, questioned donating so much money to a charity and to fight a disease based on an internet fad. Continue reading
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.
I compared the type of information that was being conveyed to the public in major newspapers to the statements made by scientists in the scientific literature. I confirmed that information in major newspapers was statistically more likely than the scientific literature to say that adult stem cells give the same or similar results as research with embryonic stem cells. A more detailed explanation of the study along with the results is available here. Continue reading
In the wake of the Hobby Lobby decision, the US Department of Health and Human Services announced on Friday proposed rules regarding exemptions for those objecting to the contraceptive mandate. Whenever I read about conscientious objections to health care services made by providers, patients, or indeed, employers, I am reminded that all objections are not equal.
As Mark Wicclair, and others, have written, studies show that medical professionals may object to services based on clinically false information. For instance, certain pharmacists reported that they objected to emergency contraception on the mistaken belief that Plan B was the same thing as RU-486 (mifepristone, or the “abortion pill”). Similarly, a prominent general practitioner admitted to making decisions regarding the prescription of oral contraception without fully understanding the mechanisms of operation that prevent pregnancy. If medical professionals make decisions based on ignorance, one can suspect that lay employers and patients do as well.
This suggests that individuals often lack the information necessary to truly assess their stance on morally controversial services. While the law does (and should) play a role in protecting conscience, it seems unsatisfying when such protection is granted to those holding underdeveloped views, and at the expense of (and detriment to) those seeking legal medical services.
I have blogged a few times about the current backlog in Medicare’s coverage appeals process, including observations about a lawsuit by providers challenging the backlog in federal court in the District of Columbia. (See here.) Yesterday a new lawsuit was filed, this one a class action lawsuit by beneficiaries represented by the Center for Medicare Advocacy. (See their press release here.) The case is Lessler et al. v. Burwell, 3:14-CV-1230 (D.Conn.). I am blocked from accessing the complaint on PACER but am working on getting a copy.
Without access to the complaint it is dangerous to speculate, but I wonder whether this suit may be subject to many of the exhaustion-based arguments that I thought could lead to dismissal of the provider suit. But the Center for Medicare Advocacy has had success pursuing class action suits on behalf of Medicare beneficiaries before, most notably the Jimmo case that led to a significant change in the standard of qualification for skilled nursing care. (See here.)
One thing about this suit that may only be interesting to administrative law buffs is the choice of forum. This case was filed in Connecticut, not the District of Columbia (where the providers filed their suit). As I have written about elsewhere, there are pros and cons to channeling administrative law cases through DC, among them DC’s expertise in exhaustion and other administrative law issues.
I can’t say whether the Center for Medicare Advocacy chose to file in Connecticut rather than the District solely because that is their home forum, or whether they thought they’d get a more sympathetic judge/more plaintiff-friendly exhaustion doctrine. And the same goes for the providers’ choice to file in the District rather than some other state. I can say from experience, though, that the choice can really matter; DC judges’ familiarity with administrative law issues just makes them perceive these cases differently from the start. So it would not surprise me at all if there are considerations beyond mere location at play here. (Not that there’s anything wrong with that!)
Health law practice is undergoing radical restructuring in the wake of major changes in the health care system and the reorganization of the legal profession. The health care system is being transformed as the Affordable Care Act (ACA) and other factors promote the integration of clinics and hospitals, put greater emphasis on patient-centeredness, create incentives for value-based care, mandate public reporting on costs and outcomes, and provide subsidized coverage. These changes in the health care system come at a time when the legal profession is also undergoing significant transformations. In the corporate law sector, we see a major shift in the role of corporate general counsel and corresponding changes in the practice of outside corporate firms: General Counsel positions (GCs) are becoming more powerful and corporate firms are shifting from overall representation of companies to specialist niches. At the same time there is increased concern about access to justice for under-represented individuals while new programs to address unmet legal needs are emerging. Health care lawyers are caught up in this dual transformation as the nature and the setting for their practices change and they are called on to play new roles and develop new skills.
Our study of Transformations In Health Law Practice concentrates on two types of practice: the corporate law sector that serves business and the “access to justice” sector that assists individuals. Continue reading
By Tara Adams Ragone
Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for increased training of law enforcement in crisis intervention as well as the need for improved access to treatment for people with mental illness.
The first is a video of the fatal police shooting of Kajieme Powell in St. Louis, Missouri earlier this month. Mr. Powell was twenty-five years old and suspected of shoplifting junk food from a convenience store. The first eighty seconds of the video show Mr. Powell pacing and muttering on the sidewalk — with four pedestrians passing by without incident — before the police arrive. The police then exited their vehicles with their guns drawn, shouted at Mr. Powell to drop his weapon, and fired about twelve shots fewer than twenty seconds after they arrived on the scene.
The second is an NPR story that included an audio recording of law enforcement officials in San Antonio, Texas responding to a 911 call about a twenty-four year old group home resident named Mason, who was off of his medications, had set his blanket on fire, and was a danger to himself and others. When they arrived at the scene, the officers acknowledged that they did not use the “tough guy command voice” that they typically would in responding to a 911 call reporting suspected criminal activity. Instead, in plain clothes and without their weapons drawn, they spoke calmly with Mason, reassuring him that they wanted to get him help. They astutely noticed signs suggesting that Mason was experiencing tactile, auditory, and visual hallucinations, and with patience and skilled questioning, got him to acknowledge the hallucinations and seek psychiatric treatment.
The San Antonio officers were members of a six-person mental health squad that the city created to confront severe prison overcrowding. Continue reading
Art Caplan has a new video on Medscape laying out the principles behind rationing limited supplies of experimental ebola treatments. As he explains:
I believe the answer to the question of who should receive the drug is: people we can both learn from and potentially help the most. I believe those are the 2 values we use when trying to ration access to an experimental drug. If we do not learn whether something is safe and effective, then we have missed an opportunity, even in the middle of an epidemic, to find out whether it is worth giving out drugs that are new, untested, and unapproved. People who should be included are those who can be observed and kept under surveillance — not for a day or a week but probably for months and years. That favors people who are not in rural villages. That favors people who will have access to hospital facilities. Those criteria will drive the selection of who receives a new, unapproved drug.
Click here to see the video and read more.
Many health law profs have wondered about how state officials can turn down bucketloads of federal money, without suffering the ire of their local constituents. In states like Arizona, that frustration was spoken most vocally by the local healthcare industry and their employees, who have the most to gain from the expansion of coverage, even if the Medicaid beneficiaries are unlikely to themselves have political clout.
Well, over at the New Yorker, Sam Wang has now compiled the polling data for the gubernatorial races to ask whether “In Swing States, Is Obamacare an Asset?” This graphic tells the whole story, focusing on states where Republican incumbents who made Medicaid-expansion decisions are now up for re-election:
Although voters respond to a mix of positions and personalities, and these are only nine states, it is striking that the governors who declined federal money to cover their most vulnerable are also the most vulnerable at the polls.
In “Ethical considerations of experimental interventions in the Ebola outbreak“, published yesterday by The Lancet, Zeke Emanuel and I discuss what we take to be the key ethical questions about the use of Zmapp and other investigational agents in the current Ebola epidemic. In essence, we argue that the national and international response to the epidemic should focus on containment and strengthening health systems, rather than experimental treatments and vaccines; that experimental interventions, if they are used, should be distributed fairly and only in the context of clinical trials; and that advance planning is needed for research in future Ebola and other epidemics, as well as for making any proven interventions against Ebola accessible in affected regions.
The full article is available open access. Be sure to check out the Lancet’s new Ebola Resource Centre as well, which includes many other interesting pieces and a podcast (access here podcast) covering—among other things—our paper.
Check out the August 22nd 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.
In “Is it ethical to hire sherpas when climbing Mount Everest?,” a short piece out today in the British Medical Journal, I suggest that the question of whether it is ethical to pay sherpas to assume risks for the benefit of relatively affluent Western climbers is a variant of cases–common in medical ethics–where compensation and assumption of risk coincide. Consider offers of payment to research subjects, organ sales, and paid surrogacy. As a result, medical ethics can offer helpful frameworks for evaluating the acceptability of payment and, perhaps, suggest protections for sherpas as we look forward to the next climbing season on Everest.
I owe particular thanks to Nir Eyal, Harvard Medical School Center for Bioethics and Harvard School of Public Health Department of Global Health and Population; Richard Salisbury, University of Michigan (retired); and Paul Firth, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital.
Take a look and let me know what you think.
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.
One of the main problems with regulating dietary supplements is that they are not all the same. We probably don’t need heavy regulation for Vitamin C, except maybe in formulation/content. We know, for example, that it is water soluble, so it is hard to take too much. So, maybe Vitamin C doesn’t pose the same safety concerns as other supplements. However, a recent article in Nature, vol. 510, pages 462-4, described different scientific viewpoints about the efficacy of vitamin supplements in healthy populations. So, unless you have a Vitamin C deficiency, then there is probably little reason to take it.
As of August 5, 2014, all foods labeled “gluten-free” must meet the requirements of the gluten-free labeling final rule. The rule implements a portion of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, which directed the Secretary of Health and Human Services to issue a regulation to define the term “gluten-free.” The U.S. Food and Drug Administration (FDA) set a gluten limit of less than 20 parts per million for foods that carry the “gluten-free” label, which is the lowest level that can be reliably detected using scientifically validated analytical methods.
According to the FDA, the “final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.” Celiac disease is an immune reaction to eating gluten–a protein occurring in wheat, rye, and barley–that causes damage to the lining of the small intestine. This damage limits patients’ ability to absorb nutrients and can lead to a host of serious health problems. While there’s no cure for celiac disease, following a strict gluten-free diet can alleviate its symptoms. The new labeling requirements will surely give patients with celiac disease a powerful tool for managing their health, and has been lauded by patient advocacy organizations such as the American Celiac Disease Alliance.
Yet, folks with celiac disease won’t be the only ones keeping an eye on the new labels. While only three million Americans have celiac disease, avoiding gluten has become a food fad. Eleven-percent of households report that they buy gluten-free products, and almost a third of Americans report that they are trying to avoid gluten. Food producers feeding the growing appetite for gluten-free have put the gluten-free label on foods that never included gluten, like vegetables and yogurt. As a result, U.S. sales of foods labeled gluten-free (which may or may not have had gluten to begin with) have doubled to $23 billion in the past year from $11.5 billion four years ago.
Unfortunately, current research doesn’t support the numerous health claims that have been made about gluten-free diets. Moreover, buying gluten-free isn’t necessarily a healthier option—many gluten-free foods contain fewer vitamins, less fiber, and more sugar. It will be interesting to watch what happens to the sale of “gluten-free” foods as the gluten-free labeling final rule takes effect.
A short article in the New Yorker on my favorite topic – business models for antibiotic use and innovation.
On Friday, the Defense Advanced Research Projects Agency (DARPA) announced a challenge to the public: provide the most accurate forecast of the spread of chikungunya virus in each of the countries in the Pan American Health Organization, win $150,000. Innovation prizes like DARPA’s are increasing in popularity, with public and private entities alike issuing challenges across a variety of subjects and methodologies. DARPA isn’t the first to announce a disease forecasting prize, either – the Centers for Disease Control (CDC) recently awarded a prize for predicting the timing and intensity of last winter’s flu season. But the choices both to focus on chikungunya and to do so using a prize fund are interesting ones that deserve further discussion.
Chikungunya is a viral disease spread by infected mosquitoes, much like the better-known malaria and dengue fever. Its symptoms often resemble those of dengue, whose other common name – breakbone fever – is telling. Chikungunya is rarely fatal, but it is often temporarily disabling, until the disease has run its course. And unfortunately, also like dengue, there is no specific treatment for chikungunya, although recent Phase I trials of a candidate vaccine appear to have been successful. But perhaps most importantly for DARPA’s purposes, chikungunya is also experiencing a resurgence in the Americas, including in the United States.
The American Health Lawyers Association is the nation’s largest group of practicing health law attorneys, with awesome CLE programs.
For the past couple years, a group at AHLA has been evaluating how health law is taught at law schools, with a view to prepare students for the practice of health law. AHLA surveyed many health law practice group chairs and other leaders. With that data, a large group of AHLA members and some full time professors evaluated health law curricula nationwide. A guidance document is now out (html or pdf):
We found some significant gaps, however, between what law schools offer and what the profession hopes to see in new health lawyers. Members of the American Health Lawyers Association (AHLA) want to see more substantive classes in fraud & abuse, business, tax, life sciences, and health care reimbursement. Desired skills include working in teams, processing practical transactional skills, and effectively analyzing client-focused problems.
Two take-away slides from the AHLA survey of health law practice leaders and hiring partners:
- Søren Rud Kristensen et al, Long-Term Effect of Hospital Pay for Performance on Mortality in England, N Engl J Med
- David Hyman & Charles Silver, Double, Double Toil and Trouble: Justice-Talk and the Future of Medical Malpractice Litigation, SSRN/DePaul L.Rev.
- George Annas, Medical Marijuana, Physicians, and State Law, N Engl J Med
- Erik Wallace et al, Hospital Relationships With Direct-to-Consumer Screening Companies, JAMA