Monday, June 9, 2014
Today, the New York Court of Appeals heard arguments on Former Mayor Michael Bloomberg’s 2012 proposed restriction on the sale of large sizes of sugary drinks by certain businesses in New York City. The New York City Department of Health and Mental Hygiene (DOHMH) and Board of Health argued before the Court to reinstate the rule, which would restrict the sale of soda and other sugary beverages larger than 16 ounces. Based on preliminary reports, they may have had a promising audience (at least, based on Chief Judge Jonathan Lippman’s questions). According to the New York Daily News, Lippman described the portion cap as a “relatively modest regulation” and “questioned why it was any different from previous efforts to ban trans fats or add fluoride to water.” Lippman further asked the attorney representing the American Beverage Association and other opponents of the ban, “Put aside the hype about what they are doing, what is so revolutionary?” This is in line with the arguments that the Board of Health and DOHMH made in their brief before the Court of Appeals. They argued that the Board has legislative authority in the area of public health, "which is demonstrated through its previous requirements of fluoridation of city water, posting calorie counts on menus, restricting trans fat use in restaurants, and banning the use of lead paint in residences." Although sometimes referred to as the Big Gulp ban, and the basis of endless fodder for late night television gags, the proposed rule actually did not actually ban any soda and did not apply to convenience stores, grocery stores, corner markets, gas stations and the like. Rather the portion cap rule limits the serving size for “non-diet soft drinks, sweetened coffee and tea, energy and sports drinks, hot chocolate, and sweetened juices, but excludes alcoholic beverages, milkshakes, fruit smoothies, mixed coffee drinks, mochas and lattes, and 100 percent fruit juices."
Sunday, June 8, 2014
Hanneke Verwey, Pieter Carstens, Informed Consent to Cosmetic Surgery – Does a Broader Duty of Disclosure Exist?, 76 J. of Contemp. Roman-Dutch Law 642 (2013).
Isabel A. Karpin, Jenni Millbank, Anita Stuhmcke, Eloise Chandler, Analysing IVF Participant Understanding of, Involvement in, and Control Over Embryo Storage and Destruction in Australia, 20 Journal of Law and Medicine 811 (2013).
Bianca Phillips, Telemedicine: Why the Law Must Change to Promote a Better Healthcare System, 11 Privacy L. Bull. (2014).
Guest Blogger Professor Erin Fuse Brown: IPAB May Be A Super-Independent Agency, But It Is Constitutional
The Ninth Circuit is scheduled to hear oral argument on June 10 in the Coons v. Lew case (9th Cir., No. 13-15324, formerly Coons v. Geithner) challenging the constitutionality of the Independent Payment Advisory Board (IPAB). The plaintiffs allege that Congress’s creation of IPAB violates the separation of powers doctrine.
The District Court upheld IPAB’s constitutionality, concluding without much explanation that Congress provided a sufficiently intelligible principle to survive a nondelegation challenge. On appeal, the plaintiffs argue that in addition to nondelegation, the court should consider a free-floating separation of powers argument that Congress violated the doctrine when it insulated IPAB from judicial review and made IPAB’s decisions and authority unrepealable. However, courts have not recognized such a free-floating separation of powers claim, and as explained below, IPAB and its proposals are repealable. Because they are challenging the degree of authority and discretion given by Congress to IPAB, the plaintiffs’ claim is at base a nondelegation claim, and the Supreme Court has only struck down a delegation of authority as lacking an intelligible principle on only two occasions, neither of which are even close to being comparable to this case. Congress provided a litany of principles to constrain the discretion of IPAB when it formulates its proposals to contain Medicare costs. Even with a conservative panel, it seems unlikely the Ninth Circuit will stretch the nondelegation doctrine so far beyond its narrow scope to invalidate IPAB on these grounds. The separation of powers challenge to IPAB is likely to fail.
HealthLawProf Blog extends a big welcome to the fourth of four guest bloggers for the month of June, Assistant Professor Erin Fuse Brown:
Erin C. Fuse Brown, is an Assistant Professor of Law at Georgia State University College of Law. She teaches Administrative Law; Health Law: Finance & Delivery; and the Health Care Transactional & Regulatory Practicum. She is a faculty member of the Center for Law, Health & Society. Her research interests are in the intersection of the business and regulation of health care delivery systems. Her recent scholarship has focused on policies affecting hospital prices for health care services and on the structural fragility of the right to health care in the Affordable Care Act. Professor Fuse Brown came to GSU from Arizona State University’s Sandra Day O’Connor College of Law, where she was a visiting assistant professor and visiting fellow in ethics and health policy with the Lincoln Center for Applied Ethics. Previously, she practiced in the health care group of the San Francisco office of Ropes & Gray LLP and clerked for Judge Alan C. Kay on the U.S. District Court in the District of Hawaii.
HealthLawProf Blog is honored to welcome the third of four guest bloggers for the month of June, Associate dean and Professor Alicia Ouellette:
Alicia Ouellette, the Associate Dean for Academic Affairs and Professional Life and a Professor of Law at Albany Law School and a Professor of Bioethics in the Union Graduate College/ Mt. Sinai School of Medicine Program in Bioethics. Her research focuses on health law, disability rights, constitutional law, children’s rights, and human reproduction. Her book, Bioethics and Disability: Toward a Disability Conscious Bioethics, was published in 2011 by Cambridge University Press. She has authored numerous articles published in academic journals such as the American Journal of Law and Medicine, the Hastings Center Report, the American Journal of Bioethics, the Hastings Law Journal, the Indiana Law Journal and Oregon Law Review. Following her clerkship with the Hon. Howard A. Levine on New York’s Court of Appeals, she served as an Assistant Solicitor General for the State of New York from 1996 to 2001.
HealthLawProf Blog is excited to welcome the second of four guest bloggers for the month of June, Professor Wendy K. Mariner:
Wendy K. Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health and Professor of Law at Boston University School of Law. She co-directs the Health Law Program at the School of Law and directs the JD-MPH Dual Degree Program at the School of Public Health. Her research and teaching focuses on patient rights, risk regulation, health insurance, the Affordable Care Act, medical privacy, public health, and research with human subjects. She co-authored (with Ken Wing, George Annas & Dan Strouse) the law school casebook Public Health Law, whose second edition will be published in fall 2014. She has degrees from Wellesley College (B.A.), Columbia University School of Law (J.D.), New York University School of Law (LL.M), and Harvard School of Public Health (M.P.H.).
HealthLawProf Blog is very pleased to welcome the first of four guest bloggers for the month of June, Associate Professor Seema Mohapatra:
Seema Mohapatra is Associate Professor of Law at Barry University Dwayne O. Andreas School of Law. She teaches Health Care Law, Bioethics, Torts I and II, and Business Organizations. Her current research focuses on the standard of care and informed consent issues in prenatal genetic testing. She is also working on a project on public health and trust (in the tobacco, food labeling, and vaccination context). Her past work has focused on health disparities between in general and in various contexts such as stem cell donations and new assisted reproductive technology like egg freezing. She also serves as the Deputy Book Review Editor for the Journal of Legal Medicine. She received her Masters in Public Health in Epidemiology at Yale University and her Juris Doctor from Northwestern University School of Law. Her recent research can be found on SSRN.
Wednesday, June 4, 2014
Is “The Right to be Forgotten” a Misnomer? More on the Recent Decision of the European Court of Justice
For blog readers interested in how the "right to be forgotten" is playing out in Europe, I'm providing the following as a further description of the recent decision of the European Court of Justice (ECJ) delightfully discussed in Nic Terry's recent post.
The recent ECJ decision about the so-called “right to be forgotten” has been hailed as highly privacy protective and condemned as “censorship.” It is neither. Rather, it is a decision about the indexing practices of search engines. It concludes that search engines are data processors with independent obligations under European privacy law; that the rights of individuals to privacy and the protection of personal life must be balanced against rights to information; and that if information is inaccurate or irrelevant because of the passage of time, the balance should be struck in favor of protecting the individual. The balance may be different for web sites originally publishing the information--a question not at issue in the ECJ decision. And it may be different for public figures, also not at issue in the ECJ decision.
The actual case, Google Spain SL v. Agencia Espanola de Proteccion de Datos, was initiated with a complaint to the Spanish data protection authority brought by Mr. Costeja González against Google Spain and the newspaper La Vanguardia Ediciones. In 1998, the paper had published notice of a sale of property to satisfy social security debts. The publication was legal—indeed, was legally required as a method to obtain publicity for the sale at auction. Costeja González contended that the proceedings had been fully resolved for many years and that therefore the information about the debt should no longer be publicly available. There were two aspects of this question: whether the newspaper should continue to make the information available on its website and whether search engines should be able to pick up the link to the information from the newspaper web page. The Spanish data protection authority concluded that the newspaper should be able to continue to have the information on its web site, as it was a lawfully published record, but that operators of the search engines against the wishes of the data subject violated the dignity of the person and the fundamental right to data protection. Google sought to block the ruling in Spanish court, and the court referred the questions presented to the ECJ.
The case involved a number of issues about the interpretation of the European Union’s data protection directive, 95/46/EC. These included whether Google Spain was within the jurisdiction of Spain’s data protection authority as an “establishment” (yes) or a “use[r] of equipment” (answer unnecessary), whether search engine location and prioritization of data was “data processing” (yes), and whether an entity performing search engine functions was a “data controller” (yes).
With respect to the right to be forgotten, the initial question was whether responsibilities attached only to the website publishing the information—in this case, the newspaper—or to the search engine as well. Google contended that any questions about removal should be address to the web site, the entity in the best position to determine whether publication of the material was lawful. In addition, Google contended, to require search engines to remove links to lawfully published material would violate the rights of the web site publishers and internet users. Costeja González contended that individuals should be able to approach search engines directly, and that the obligations of the search engine were independent from the obligations of the web site. On this point, the ECJ interpreted Directive 95/46/EC in light of the Charter of Fundamental Rights of the European Union Article 7 right to respect for private life and Article 8 right to the protection of personal data. The ECJ agreed with Costeja González that each data controller had obligations to determine whether its form of processing of the data was permissible under Directive 95/46/EC and the Charter. Determining the legitimacy of processing, the ECJ determined, requires balancing the rights and freedoms of the data subject with the legitimate interests of the data controller; this balance may not be the same for search engines and web page publishers. With respect to search engines, use of algorithms that search by individual name are particularly problematic for the fundamental right to privacy because of the way they permit easy assembly of structured profiles of individuals. The mere economic interests of the search engine cannot override this fundamental right. However, legitimate interests of other internet users in obtaining information about the individual must also be considered and “a fair balance should be struck between [those interests] and the data subject’s fundamental rights.” In the words of the ECJ, “Whilst it is true that the data subject’s rights protected by those articles also override, as a general rule, that interest of internet users, that balance may however depend, in specific cases, on the nature of the information in question and its sensitivity for the data subject’s private life and on the interest of the public in having that information, an interest which may vary, in particular, according to the role played by the data subject in public life.” (¶ 81) In contrast, publication of the information on the web site is both less intrusive and may be legitimate. Web site publication may also come within the exception for journalism in Directive 95/46/EC.
Finally, the ECJ analyzed the scope of the data subject’s rights against search engines. Here, the question was whether the data subject has the right to request search engines to remove links to lawfully published, true information. Costeja González contended that his interest in protecting his privacy from the publication of prejudicial information overrode the interests of the search engine and the general interest in freedom of information. The ECJ determined that under Directive 95/46/EC, information may over time become inadequate or no longer relevant. Such was the case with information about long-resolved old debts for an ordinary individual. In such cases of outmoded information, the data subject should have the right to request limits to its processing. For more public figures, however, the rights to information might override the rights of the data subject. (¶ 97)
Monday, June 2, 2014
The President’s Council of Advisors on Science and Technology (PCAST) has issued a report intended to be a technological complement to the recent White House report on big data. This PCAST report, however, is far more than a technological analysis—although as a description of technological developments it is wonderfully accessible, clear and informative. It also contains policy recommendations of sweeping significance about how technology should be used and developed. PCAST’s recommendations carry the imprimatur of scientific expertise—and lawyers interested in health policy should be alert to the normative approach of PCAST to big data.
Here, in PCAST’s own words, is the basic approach: “In light of the continuing proliferation of ways to collect and use information about people, PCAST recommends that policy focus primarily on whether specific uses of information about people affect privacy adversely. It also recommends that policy focus on outcomes, on the “what” rather than the “how,” to avoid becoming obsolete as technology advances. The policy framework should accelerate the development and commercialization of technologies that can help to contain adverse impacts on privacy, including research into new technological options. By using technology more effectively, the Nation can lead internationally in making the most of big data’s benefits while limiting the concerns it poses for privacy. Finally, PCAST calls for efforts to assure that there is enough talent available with the expertise needed to develop and use big data in a privacy-sensitive way.” In other words: assume the importance of continuing to collect and analyze big data, identify potential harms and fixes on a case-by-case basis possibly after the fact, and enlist the help of the commercial sector to develop profitable privacy technologies.
The report begins with an extremely useful (and particularly frightening if you aren’t familiar with the internet of things) description of big data possibilities, now and in the near-term future. The description emphasizes the distinction between data “born digital”—that is, created in digital form—and data “born analog”—arising from the characteristics of the physical world and then becoming accessible in digital form. Data born analog are highly likely to contain more information than just that of particular digital interest; for example, surveillance cameras record everything that is occurring in a particular location, not just acts that are the target of surveillance. But with analytics that allow data fusion, the combination of data sources may reveal new meanings, for example profiling individuals. Big data are high volume, high velocity, and high variety, an intersection that presents serious privacy challenges.
PCAST then attempts to anticipate the privacy harms that might be associated with big data collection and analysis. The harms are in the main presented as byproducts of the benefits of developments of particular types of technologies. The list is impressive, but may miss additional harms associated with the development of a big data world. Here’s a table listing developments, benefits, and harms; I’ve marked with an asterisk benefits that I’ve reconstructed from what PCAST says but that PCAST does not state explicitly.
Social networking across geographical boundaries; social and political participation on a far larger scale
Shared pipelines and the possibility of interception
Ability to store, organize, and share personal records, e.g. cloud storage of photographs.
“Home as one’s castle” should extent to “castle in the cloud,” not currently protected
Inferred facts about individuals
Delivery of desired or needed services, e.g. targeted marketing
Inferences may be drawn about highly sensitive facts about the individual (e.g. sexual orientation)—facts of which the individual may not even be aware (e.g. early dementia)
Services such as navigation or routes, finding people or services nearby, avoiding hazards
Stalking and tracking
Benefits of use of statistically valid algorithms
False conclusions about individuals may be drawn
Discovery of special cases that apply to individuals within a population
May allow tailoring of services to special cases—e.g. personalized medicine, instruction linked to learning styles*
Foreclosure of autonomy—individuals may not want to take the predicted path
Identification of individuals
May allow individuals to be warned or protected or otherwise benefited*
Loss of desired anonymity
PCAST intentionally omitted from this list desires that information be used fairly and that individuals know what others know about them or are doing with their information. In the view of PCAST, neither of these “harms” can be sufficiently defined to enable policy recommendations. Also omitted from this list are more overarching concerns such as effects on identity, security, stigmatization of groups, freedom of expression, or political liberty.
PCAST’s discussion of the current technologies of privacy protection is highly informative and readers with interests in this area would do well to read the report—I won’t summarize it here. The report also debunks several standard methods for privacy protection: notice and choice (a “fantasy”), de-identification (ineffective in light of the development of analytics enabling re-identification), and non-retention or deletion (hopeless given potential for copying including the creation of multiple copies at the point analog data become digital).
Instead, the report suggests several different approaches for protection against data misuse. As a successor to notice/consent, PCAST recommends the development of “privacy preference profiles,” perhaps by third parties such as the ACLU or Consumer Reports; apps or other internet entities could then indicate whether their privacy policies comport with a profile specified by the consumer. Or, the profile developers might offer the service of vetting apps. Ideally, technologies could be developed to perform the vetting automatically. PCAST also recommends developing use controls associated with data collection, use, and subsequent transmission of data or uses. Metadata might serve this purpose but there is clearly need for further development. Another suggested strategy is audit capability as a deterrent to misuse. Finally, PCAST suggests implementing the Consumer Privacy Bill of Rights through recognition of potential harmful uses of data. Emphasis should be placed on development of best practices to prevent inappropriate data use throughout the data life cycle.
Five major policy approaches (they are called recommendations, but they are far better characterized as general directions rather than specific recommendations) conclude the report. They are:
--attention should focus on uses of big data rather than collection and analysis
--policies should not be stated in terms of technical solutions but in terms of intended outcomes
--the US should strengthen privacy-related research, including relevant social science informing successful application of technologies
--the US Office of Science and Technology Policy should increase education and training efforts
--the US should take international leadership by adopting policies that stimulate the development of privacy protective technologies.
These recommendations seem remarkably anodyne after the detailed discussion of technologies that preceded them. Moreover, they are also preceded by some other, less anodyne policy observations (I found these quite troubling—for reasons I just begin to suggest parenthetically below):
--basing policy on data collection is unlikely to succeed, except in very limited contexts (such as health information) where there may be possibilities for meaningful notice and consent. (Why, I ask, is notice/consent the only way to approach collection practices? What about other sorts of restrictions on collection? Or, is the thought that getting the data is both inevitable and desirable, no matter what the context?)
--regulating at the moment individuals are particularized by analytics might be technically possible—but even so, it’s preferable to focus on harms downstream (Doesn’t this expose people to risks of harm, correctable only after the fact? Shouldn’t we consider building ways to detect and deter re-identification that could intervene before the harm occurs?)
--drafting savvy model legislation on cyber-torts might help improve the current patch-work of liability rules for privacy violations (Why not a public law approach to violations rather than placing the onus on individual litigation?)
--forbidding the government from certain classes of uses might be desirable, even if these uses remain available in the private sector (So is the government the only or even primary problem with big data use???)
Saturday, May 31, 2014
Cross-posted from Bill of Health
Privacy is never easy to think about. This week it became harder. Two pieces framed my week. First, Eben Moglen’s essay in The Guardian (based on his Columbia talks from late last year) took my breath away; glorious writing and stunning breadth combined to deliver a desperately sad (but not entirely hopeless) message about government and corporate overreaching in data collection and processing.
A wry speech posted by software developer Maciej Ceglowski also helped frame my thoughts. He wrote, “The Internet somehow contrives to remember too much and too little at the same time, and it maps poorly on our concepts of how memory should work.” There’s the problem in a nut. Ceglowski alludes to the divide between how human (offline) memory operates (it’s “fuzzy” and “memories tend to fade with time, and we remember only the more salient events”) and the online default of remembering everything. Government and Google and, for that matter, Big Data Brokers tell us that online rules now apply across the board and ‘that’s just peachy’ because we’ll have better national security, better searches, or more relevant advertising. But, that’s backwards.
Offline rules need to apply to online data. Not everything needs to be collected and some memories should degrade or disappear. That’s very hard for our silicon-based masters to comprehend. But, remarkably, just a few weeks ago that was the conclusion of the European Court of Justice. Case C‑131/12 held that unlawful data processing “may result not only from the fact that such data are inaccurate but, in particular, also from the fact that they are inadequate, irrelevant or excessive in relation to the purposes of the processing, that they are not kept up to date, or that they are kept for longer than is necessary unless they are required to be kept for historical, statistical or scientific purposes.”
How would the denizens of online rules comply? This week Google posted a form to deal with erasure requests from EU citizens. Of course, it’s in beta (“Please note that this form is an initial effort”). Maybe making it work will require hiring some people who understand the offline sensibilities. Unfortunately vested interests and as Eric Posnerpointed out in Slate, the First Amendment, likely will conspire to deny such an offline, nuanced, balanced rule in the land of the free.
As momentous thoughts were put to paper and the EU revolution began to operationalize, what did the week bring U.S. data protection and (you thought I’d forgotten?) health privacy? Alas, not very much. The FTC published its report on the data broker industry (or more accurately on nine data brokers). Clearly the brokers subscribe to the online rule—they collect everything. And much of it, as I have argued previously, is health-related. The good news is that the agency took health data threats very seriously; a couple of years ago the attitude would have been—’well, HIPAA takes care of that.’ Not any more. The report specifically recommends, “Congress should … consider imposing important protections for sensitive information, such as certain health information, by requiring that consumer-facing sources obtain consumers’ affirmative express consent before collecting and sharing such information with data brokers.” However, although the FTC’s heart is in the right place, most of the report’s other recommendations are regulation-light, transparency and access—in this company, knives at a gunfight.
Although our offline memories seem fuzzy the more important reality is that we remember based on context and emotions, our context and emotions. Data brokers and the other powerful entities that have fallen under the gaze of Moglen, Ceglowski, and the European Court not only expropriate all our memories, but then they shape them to serve the contexts of others.
Tuesday, May 27, 2014
Guest Blogger Professor John Jacobi: Ensuring Successful ACA Follow-Through Part 3: Undocumented Immigrants
An article on the front page of Memorial Day’s New York Times highlights an emerging health access concern for undocumented persons. Hospitals – one of the few points of entry for undocumented persons to health care – are erecting barriers to care for the poor, on the grounds that the poor should be encouraged to take advantage of the programs and subsidies of the ACA. That advice is hollow for the undocumented, shut out as they are from the ACA’s benefits.
The politics of immigration at the national level drove the exclusion of undocumented persons from coverage under the ACA. As Bradford Gray and Ewout van Ginneken have noted, the United States is not the only country to restrict public funding for undocumented persons. The reasons for European restrictions sound familiar: concerns that available health care is a “magnet” for immigration, and belief that adding new users will strain the health system’s capacity. But they also point to familiar counterarguments: the human rights-based concern for the wellbeing of undocumented men, women, and children, and the pragmatic concern for sound public health measures.
In my first guest post I noted that there are many important tasks that can improve ACA implementation, and that can be accomplished by states and private actors, and without a change in federal law. Improvement of health care access for undocumented persons may be a peculiarly non-federal issue for the foreseeable future.
As the UCLA Center for Health Policy Research described in detail, undocumented persons are excluded from most of the coverage available in the ACA. The ACA left in place most exclusions from Medicaid and CHIP (except for emergency care), and excluded the undocumented from premium subsides for private coverage. The mean-spirited topper is the prohibition against undocumented persons purchasing on an exchange – even at full price.
Poor people live shorter lives, substantially shorter in certain impoverished communities. A recent New York Times article highlighted the significant gaps in life expectancy among different counties in Virginia: “Residents of Fairfax County are among the longest-lived in the country: Men have an average life expectancy of 82 years and women, 85, about the same as in Sweden. In McDowell, the averages are 64 and 73, about the same as in Iraq.”
The poor are less likely to have access to needed health care and more likely to smoke, be overweight, and to live with constant stress, which we now know is harmful to the human body. It is at this critical juncture (as well as others) that public health and human rights meet. As public health professionals focus on the social determinants of health, relatively few approach these issues through a human rights framework or in partnership with human rights advocates. Likewise, human rights activists miss opportunities to partner with, and build upon the work of, public health.
The social determinants of health implicate human rights, and visa versa. And while highly politicized debates swirl around the causes of poverty among adults, everyone ought to be able to recognize that no child chooses his or her place of birth. Yet where and to whom you are born affects access to health care, education, and ultimately life expectancy. And even within the United States, the ensuing differences can mean an additional decade or more of life. Or the opposite.
The Convention on the Rights of the Child (CRC), the most widely ratified human rights treaty in history, requires countries to “ensure to the maximum extent possible the survival and development of the child” (article 6). It also mandates that governments ensure every child is protected from harm and is able to realize his or her rights to health care, education, and an adequate standard of living necessary to enable the child to develop to his or her fullest potential.
The elephant in the room, of course, is that the United States is one of only three countries in the world (along with Somalia and newly independent South Sudan) that have yet to ratify the treaty. But this is not an article about the U.S. government’s approach to human rights treaties or the domestic politics around the CRC. Rather it is call for public health and human rights professionals to build bridges in their work, much of which has the same aims: harm reduction and the well-being of all individuals.
Whether or not progress is made on U.S. ratification of the CRC in the near term, opportunities exist now to use human rights frameworks to help address the root causes of child exploitation and poor health outcomes for children. Similarly human rights advocates can bolster their efforts by drawing on the significant work already done by public health professionals in identifying and addressing the social determinants of health.
The gaps in life expectancy across communities in the United States should compel us to utilize every tool we have. Both human rights and public health strategies can help address these disparities and their root causes.
- Professor Jonathan Todres
Monday, May 26, 2014
Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research.
The current approval process for clinical research of the effects of marijuana differs significantly from traditional research approval processes. If funded by the NIH, proposals to research marijuana must undergo traditional peer review; however, non-NIH-funded proposals must first be reviewed by a scientific review panel within the Department of Health and Human Services (an unusual step). Researchers must then submit an Investigational New Drug Application with the FDA and obtain DEA registration, as would be the case for any research on controlled substances. And finally, researchers must seek approval from NIDA in order to obtain a supply of research-grade marijuana. NIDA, a part of the NIH, is the sole entity responsible for overseeing the cultivation and distribution of all legal marijuana in the U.S., which is grown at the University of Mississippi.
NIDA has been widely criticized in recent years for not being receptive enough to research on marijuana and other Schedule I drugs. Researchers whose HHS-approved proposals have been denied by NIDA allege that NIDA has only been willing to approve research that studies the risks, not the benefits, of illegal drugs.
But perhaps these criticisms are about to change. This year, NIDA updated its website to clarify that it does indeed approve studies on the therapeutic benefits of marijuana. NITA identified 28 active grants that it has funded in the past few years to study marijuana’s effects on autoimmune disease, inflammation, pain, psychiatric disorder, seizures, and drug dependence; as well as a number of independently funded studies that received NIDA’s approval to obtain research-grade marijuana. It is in response to these approved studies that the DEA approved NITA’s request to dramatically increase the marijuana production quota.
If this trend continues, then perhaps the United States will finally be able to achieve the goals set out fifteen years ago in the Institute of Medicine’s 1999 report, Marijuana and Medicine: Assessment of the Science Base, which strongly recommended that clinical trials be conducted to study the medicinal effects of cannabinoid drugs.
This Huffington Post piece by Chelsea Carmona, Criminalizing Good Maternal Health Care in Tennessee, highlights the troublesome gendered dimensions of Tennessee’s new law criminalizing drug use during pregnancy. Tennessee’s bill takes effect on July 1st and is the first law of its kind in the United States. The Huffington Post piece notes gendered differences in women’s patterns of drug addiction, describes critical gaps in care for pregnant women in substance abuse programs, and summarizes concerns anticipating the disproportionate prosecution of pregnant women of color, particularly rural women.
What is perhaps most striking about Tennessee’s law is its enactment against such an overwhelming volume of dissent from diverse stakeholders in law, medicine, and social services. Implementation of the bill is especially complex when considered in the context of tort law. As noted, it remains uncertain how a doctor could navigate the duty of care owed to the pregnant woman undergoing methadone maintenance without risking her possible incarceration. Yet to forego the “gold standard” for treating opioid addiction seems to breach a medical standard of care as well. As the law’s effective date looms, the question becomes how opponents of this bill can capture the law’s inevitably troubling impact when the gender, class, and race dimensions are so systematic and pervasive.
Cross-posted from Gender and the Law Blog
This year marks the 50th anniversary of the release of the Surgeon General’s first report on the health consequences of tobacco. Since that report was published in 1964, more than 20 million Americans have died prematurely as a result of cigarette smoking. The annual total economic costs to the U.S. economy are now estimated to be $289 billion. This year’s Surgeon General’s report, The Health Consequences of Smoking--50 Years of Progress, contains some good news. The prevalence of cigarette smoking among adults has declined from 42% in 1965 to 18% in 2012 (though progress has slowed in recent years). And, perhaps more important, we know how to solve this problem; as the Surgeon General’s report details, “[t]he evidence is sufficient to conclude that there are diverse tobacco control measures of proven efficacy at the population and individual levels.
The harms of tobacco use are well known by anyone with interest in health care issues. Less well known are the harmful effects of tobacco production on the many children who work on tobacco farms in the United States today. In a report released earlier this month -- Tobacco's Hidden Children: Hazardous Child Labor in United States Tobacco Farming, Human Rights Watch found that:
Children working on tobacco farms in the United States are exposed to nicotine, toxic pesticides, and other dangers. Child tobacco workers often labor 50 or 60 hours a week in extreme heat, use dangerous tools and machinery, lift heavy loads, and climb into the rafters of barns several stories tall, risking serious injuries and falls.
The investigation also found that many children involved reported symptoms “consistent with acute nicotine poisoning.” In non-agricultural workplaces, labor laws prohibit the employment of children under 18 years old in hazardous occupations (such as excavation, manufacturing explosives, mining, and operating many types of power-driven equipment). Yet the same protections do not exist for children working on farms. As the Human Rights Watch investigation uncovered, this is not just a labor issue, but a health issue and a children’s rights issue. It merits much more attention.
In the United States, children under 18 years old are not permitted to buy tobacco products. We draw this line, as we do in many other areas of the law, because we recognize that children are entitled to special protections. The harmful consequences of tobacco use demand that we make every effort to prevent children from taking up smoking. Similarly, the dangers of tobacco production should convince us to end the practice of using children on tobacco farms.
- Professor Jonathan Todres
Friday, May 23, 2014
The Debate over Laura's Law: The Challenge of Providing Appropriate Care to Individuals with a Mental Disability
One of the cruelest features of some mental disabilities is that they create a level of fear and suspicion that can make it difficult for individuals to seek or accept treatment. The situation is even worse when there is no infra-structure of community mental health clinics that could help build relationships of trust with healthcare providers. The result is our current situation where county jails are often the largest mental health providers in their communities. (not this phenomena is all that recent--I and many others have been writing about it for over ten years).
California's Laura Laws that provide mechanisms for mandatory outpatient treatment are one way of keeping people are a way of keeping people whose only crime is having an illness out of jail. But as the current debate over their use shows, any kind of compelled treatment raises important concerns about respect for civil liberties. Yet some advocates for the mentally ill are supporting the law's implementation because it provides funds for outpatient treatment that would otherwise be unavailable.
News of efforts to provide increased services to those with severe mental disabilities is always of interest--but this policy debate in California is especially so because the arguments on both sides--for providing treatment to those not seeking it--are compelling and thoughtful.
Thursday, May 22, 2014
E. H. Morreim, Dumping the 'Anti-Dumping' Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters, 5 Minn. J. L. Sci. & Tech 211 (2014).
Nav Persaud, Thom Ringer, Trudo Lemmens, How Can Journals Respond to Threats of Libel Litigation, 11 PLOS Medicine 1 (2014).
Valerie Gutmann Koch, A Private Right of Action for Informed Consent in Research,45 Seton Hall L. R. __ (2015).
Glenn Cohen, What (If Anything) Is Wrong with Human Enhancement? What (If Anything) Is Right with It?, 49 Tulsa L. Rev 645 (2014).
Julian James Zuba Polaris, Principles Over Principals? How Innovation Affects the Agency Relationship in Medical and Legal Practice, Yale J. of Health Policy, Law, and Ethics (Forthcoming).
Tracy D Gunter, Can We Trust Consumers with Their Brains? Popular Cognitive Neuroscience, Brain Images, Self-Help and the Consumer, Indiana Health L. Rev. (Forthcoming).
Trudo Lemmens, The Markingson Case and the Ethics of Institutional Proceduralism, 11 Bioethical Inquiry 11 (2014).
Bert-Jaap Koops, The Role of Framing and Metaphor in the Therapy versus Enhancement Argument, Pisa U. Press 35 (2013).
Jenna Feldman, Medical Malpractice Liability and Accountability: Potential Legal Ramifications and Solutions for Florida ACOs, U. of Miami L. Rev. (Forthcoming).
Mahmood Moosazadeh, Mahtab Movahednia, Nima Movahednia, Mohammadreza Amiresmaili, Iraj Aghaei, Determining the Frequency of Defensive Medicine Among General Practitioners in Southeast Iran, 2 Int. J. Health Policy Manag. 119 (2014).
Donald H. Stone, The Dangers of Psychotropic Medication for Mentally Ill Children: Where is the Child's Voice in Consenting to Medication? An Empirical Study, 23 Temple Pol. & Civ. Rts. L. Rev. 121 (2013).
Jeffrey W. Sheehan, Late Fathers' Later Children: Reconceiving the Limits of Survivor's Benefits in Response to Death-Defying Reproductive Technology, 15 Vand. J. Ent. & Tech. L. 983 (2013).
Charles Maimela, Professional Medical Malpractice: Legal Liability of the Plastic Surgeon, 76 J. of Contemp. Roman-Dutch L. 589 (2013).
Jonathan R. Montgomery, Caroline Jones, Hazel Biggs, Hidden Law‐Making in the Province of Medical Jurisprudence, 77 The Modern L. Rev., 343 (2014).
Wednesday, May 21, 2014
Guest Blogger Professor John Jacobi: Ensuring Successful Reform Follow-Through, Part 2: Affordability
Health reform is an ongoing project. In my last post, I noted that the success of ACA enrollment frees up some bandwidth to grapple with other outstanding implementation tasks – tasks that are vital to supporting the goals of the Affordable Care Act. I tried to focus on issues with a short- or medium-term horizon, and which could be tackled largely by state or private-sector actors – that is, without change in federal law. In this post, I’ll talk about affordability (the first “A” in the ACA). First, the good; then, the problems; finally, some potential solutions.
Almost five million new Medicaid enrollees, of course, have affordable care. There are indications that Medicaid expansion will gradually come, in some form, in many red states, including Indiana, which is proposing what sounds like a mash-up of the Basic Health Plan and an 1115 waiver. Beyond Medicaid, several affordability provisions support access in private insurance:
- Modified community rating, with 3:1 ratio limit.
- Abolition of most annual/lifetime limits on coverage.
- Annual out-of-pocket limit of $6,350/individual and $12,700/family (2014).
- Actuarial value requirements for QHPs.
- No cost-sharing for preventive care.
Low-income purchasers on the exchanges have additional protections:
- Premium support, limiting the effective cost of coverage for people at or below 400% of FPL to 2% to 9.5% of income.
- Further reductions in out-of-pocket caps by two-thirds for those at or below 200% of FPL, by one-half for those at or below 300% of FPL, and by one-third for those at or below 400% of FPL.
- Reductions in cost sharing (point-of-care copayments and deductibles) for those below 250% of FPL, raising the actuarial value of their coverage to as high as 94%.
This protection is real and substantial – a tremendous improvement from the pre-ACA days when, as chronicled by Melissa Jacoby, Teresa Sullivan, Elizabeth Warren and others, medical debt played a large part in personal bankruptcy filings, and, significantly, the majority of those filing with medical debt were insured.
Tuesday, May 20, 2014
The ABA/AHLA program on Antitrust in Health Care this week included extensive analyses of recent challenges to provider mergers and other aspects of concentration and market power. Douglas Ross (Davis Wright Tremaine), Roxane Busey (Baker & McKenzie), and I presented a “Year in Review” analysis of significant case law and regulatory developments affecting competition in the health care sector (including a Jaryndyce v. Jaryndyce award to the case that seems to keep popping up in every annual program we do: this year’s winner by acclamation was the West Penn/UPMC/Highmark saga). Several items that may be of particular interest:
Dan Kessler discussed his empirical study, published in this month’s issue of Health Affairs, concerning the price and spending effects of hospital-physician integration. The key finding of the paper is that increases in the market share of hospitals that own physician practices leads to higher prices and spending. As discussed in my last post, antitrust authorities are paying closer attention to hospital acquisitions of physician practices, something they have ignored in the past. However, the FTC’s recent successful challenge to such an acquisition did not take on the important issue of the vertical aspects of the consolidation at issue. Another finding (though far less robust) by Kessler and his co-authors indicated that increases in market share of hospitals that had joint ventures with physicians (such as PHOs) have lower rates of admission, a result that supports the potential efficacy of ACOs.
How will exchanges affect competition? Some 23 states have seen co-ops enter their markets through the exchanges and there is some evidence that the exchange may facilitate new entry. Recall that during the run up to the ACA many called for adding a public option insurance plan to each health care exchange. The argument was that the individual insurance markets around the country were so concentrated throughout the country that consumers would not benefit from competitive markets in the exchanges. Congress chose not to add the public plans presumably on the assumption that the incentives of serving millions of new customers would incentive new entry. How has that worked out? A recent Kaiser Family Foundation study provided interesting results. It found significantly increased competition in two big states that organized their own exchanges. In New York, the Herfindahl Index (the measure commonly used to assess concentration in antitrust cases) for the individual insurance market declined from 1641 to 1197. In California, the HHI declined from 3052 to 2418. Interestingly, both states have adopted an “active purchaser” approach to their exchanges; that is, the exchanges negotiate up front with plans before they are allowed to sell their products on the exchange. Less encouraging was the result in some other states. Connecticut’s individual insurance market has less competition in its exchanges than it had prior to the ACA. Further some rural states or parts thereof have only one insurer participating in their exchanges.
Many medical providers learn about the law the way kids learn about sex – whispers with friends, internet message boards, and media depictions of the most dramatic and unrealistic kind. And while both medical schools and junior high schools offer some type of formal education, it is quite limited, especially as compared to the information these students collect through other, less reputable, sources. As a result, many medical providers go into practice with a dark cloud over their heads – the “scared straight” model of legal education, if you will.
We’ve heard a lot about the practice of defensive medicine – ordering more tests and procedures than are medically necessary in an effort to protect oneself from potential liability. But fear of liability manifests itself in other, less dramatic, ways as well – for example, in overly-restrictive interpretations of HIPAA requirements that make it difficult for patients and their care providers to access needed medical information. In reality, however, much of the fear of liability experienced by medical professionals is unfounded.
Every physician is afraid of being sued, and rightly so. According to a 2011 study in the New England Journal of Medicine, between 75% and 99% of physicians had faced a malpractice claim by the time they reached the age of 65. With rates like these, physicians must accept the fact that under our current system of litigation, someday, somehow, they are likely to be on the receiving end of lawsuit. Other professions, like engineering and architecture, face this problem as well. And without diminishing the incredible inconvenience, expense, and (perhaps most significantly) stress and mental anguish that result from being named in a lawsuit, I think it’s important that medical providers have a more realistic perspective of how likely lawsuits against them are to succeed.