AALS Call for Papers for a special Works-in-Progress for New Law School Teachers Program

Call for Papers
 AALS Section on Law, Medicine & Health Care
Works-in-Progress for New Law School Teachers
AALS Annual Meeting, Washington, DC
Saturday, January 3, 2015

The AALS Section on Law, Medicine and Health Care is pleased to announce a Call for Papers for a special Works-in-Progress for New Law School Teachers Program. The Section will run the Program from 5:15 to 6:30 p.m. on Saturday, January 3, at the AALS 2015 Annual Meeting in Washington, DC.

This program will bring together junior and senior health law scholars for a lively discussion of the junior scholar’s’ works-in-progress. Junior health law scholars will submit papers that they expect to submit in the spring 2015 law review submission cycle. After they briefly present their papers in a concurrent roundtable setting, senior scholars will provide oral comments and critiques. This new program presents an opportunity for the audience to hear cutting edge health law scholarship by recent members of the academy.

We will limit our selection to two or three papers.  Continue reading

Introducing New Blogger Robert Field

FieldRobert Field is joining Bill of Health as a regular contributor.

Robert I. Field, JD, MPH, PhD is a nationally known expert in health care regulation and its role in implementing public policy.  He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.  He is also a lecturer in health care management at the Wharton School of the University of Pennsylvania and a senior fellow of Penn’s Leonard Davis Institute of Health Economics.

Professor Field is the author of Mother of Invention: How the Government Created Free-Market Health Care, just released by Oxford University Press.  It presents an historical overview of four key health care sectors to demonstrate the underlying importance of government programs in creating and maintaining the health care system and to place health reform in the context of an ongoing evolutionary process.  He is also the author of Health Care Regulation in America: Complexity, Confrontation and Compromise, a comprehensive overview of health care regulation, also published by Oxford University Press.

Professor Field’s recent scholarly work has focused on health reform and is effects on the structure of the health care system, ethical issues in vaccines, and policy implications of genetic databases.  His work has appeared in the University of Pennsylvania Law Review, the Villanova Law Review, the Drexel Law Review, Health Affairs, Vaccine, and the Journal of Clinical Oncology.  He writes a blog for the Philadelphia Inquirer on health policy entitled the Field Clinic, which features 14 prominent Philadelphia health care leaders as regular contributors.

Professor Field speaks nationally on health care topics. He is frequently quoted in the press, including stories in the New York Times, Wall Street Journal, Washington Post, Boston Globe, Philadelphia Inquirer, and BusinessWeek and has discussed health policy issues on CNN, NPR, ABC, and numerous local television and radio stations.  He has also been a frequent commentator on WHYY, the NPR affiliate in Philadelphia.

Before joining the faculty of Drexel University, Professor Field founded and chaired the Department of Health Policy and Public Health at University of Sciences in Philadelphia, where he was also professor of health policy.  Previously, he led business planning and development for the primary care network of the University of Pennsylvania Health System. He has also conducted health policy research at the Institute of Medicine of the National Academy of Sciences and the Center for Law and Health Sciences at Boston University, practiced health law with the Philadelphia firm of Ballard Spahr, LLP, and directed public policy research for Cigna Corporation.

Professor Field earned a Ph.D. in psychology from Boston University, an M.P.H. from the Harvard School of Public Health, a J.D. from the Columbia Law School, where he was associate editor of the Columbia Journal of Environmental Law, and an A.B. magna cum laude from Harvard College.

Selected Publications

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Art Caplan New Op-Ed: When Does Human Life Begin?

Art Caplan has a new Op-Ed on The Council for Secular Humanism about when human life begin.

From the piece:

“When does human life begin? For those in the “personhood” movement in the United States, there is no doubt about when that happens—it is at conception, when the sperm meets the egg. The personhood movement has gained a foothold among antiabortion activists who are looking to pass laws that define embryos as people with full rights. Personhood advocates aim to outlaw all abortions, along with in vitro fertilization, embryonic stem-cell research, and emergency contraception. Granting embryos personhood would also mean that someone who killed a pregnant woman at any stage in her pregnancy would be at risk of prosecution for a double homicide. And in those states that restrict a woman’s right to utilize a living will if she is pregnant, no living will could apply from the moment of conception..”

Read the full article.

Introducing New Blogger Amanda C. Pustilnik

Amanda C. Pustilnik is joining Bill of Health as a regular contributor.

Pustilnik Amanda C. Pustilnik is an Associate Professor of Law at the University of Maryland School of Law, where she teaches Criminal Law, Evidence, and Law & Neuroscience. Her current research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Prior to joining the University of Maryland, she was a Climenko fellow and lecturer on law at Harvard Law School. Before entering the legal academy, she practiced litigation with Covington & Burling and with Sullivan & Cromwell, where she focused on white collar criminal matters. Prof. Pustilnik also clerked for the Hon. Jose A. Cabranes on the United States Court of Appeals for the Second Circuit. She graduated Yale Law School and Harvard College, and has been a visiting scholar at the University of Cambridge, Emmanuel College, in the History and Philosophy of Science department. Prof. Pustilnik has also worked at McKinsey & Company as a management consultant and is a member of the board of directors of the John Harvard Scholarships. During Spring 2015, Professor Pustilnik will be serving as a Senior Fellow in Law & Neuroscience of the Center for Law, Brain & Behavior at Massachusetts General Hospital.  This Center is a collaboration between Massachusetts General Hospital and Harvard Law School.

Selected Publications
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Suits for nursing-home neglects sound in general negligence rather than medical malpractice, and are consequently not subject to damage caps

By Alex Stein

The West Virginia Supreme Court has recently delivered a super-important malpractice decision, Manor Care, Inc. v. Douglas, — S.E.2d —- (W. Va. 2014), holding that suits for nursing-home neglects sound in general negligence, rather than medical malpractice, and are consequently not subject to damage caps. This decision is very well reasoned and I expect it to be followed in other states that cap medical-malpractice damages.  Continue reading

New Medical Tourism Website with Info for Patients

My good friends and co-authors at Simon Fraser University have a nice new website aimed at Canadians (though useful for people from all countries) considering using medical tourism about what to think about, questions to ask, steps to take, etc (Full Disclosure: I participated in a feedback session on the website). Here is a story about the website in the National Post, and here is the website itself.

Limelight v. Akamai: Implications for Medical Method Patents

By Rachel Sachs

Last month, as it wrapped up the 2014 Term, the Supreme Court decided a patent law case that could have a major impact on method patents in the medical arena. No, I’m not talking about Alice Corp. v. CLS Bank, the most Rorschach-like of the Term’s many patent opinions. I’m talking about Limelight Networks v. Akamai Technologies, Inc., in which the Supreme Court unanimously reversed the Federal Circuit’s ruling on the scintillating question of divided infringement under 35 U.S.C. § 271(b).

In Limelight, a splintered en banc decision, a majority of the Federal Circuit had overturned prior case law in ruling that liability for induced infringement of a method claim under § 271(b) was possible where no single entity had performed all the steps of that claim, but where those steps were divided between two or more parties, one of whom had induced the other(s) to infringe. (Previously, various opinions had held that induced infringement under § 271(b) required a single actor, just like direct infringement under current § 271(a) precedent.) In a unanimous opinion by Justice Alito, the Supreme Court reversed, essentially reinstating the single entity rule by holding that direct infringement under § 271(a) is required for inducement liability under § 271(b). Continue reading

Worth Reading This Week

By Nicolas Terry

Medical Malpractice: FTCA’s Trap for the Unwary

By Alex Stein

Anyone interested in medical malpractice must read the First Circuit’s decision in Sanchez v. United States, 740 F.3d 47 (1st Cir. 2014).

Mr. Sanchez’s wife died in a Massachusetts hospital shortly after delivering her third child by c-section. She died from arguably preventable hemorrhaging. Mr. Sanchez and his lawyer thought that they had a 3-year window for filing medical malpractice suit in connection with that death, as prescribed by Massachusetts law, Mass. Gen. Laws Ch. 260, § 2A. Unbeknownst to them, however, the hospital was a federally qualified health center, which made the doctors who treated Mrs. Sanchez “federal employees” under the Federally Supported Health Centers Assistance Act of 1992, 42 U.S.C. § 233. As a result, Mr. Sanchez could only sue the United States under the Federal Tort Claims Act (FTCA). He wouldn’t mind doing so, but his ability to file such a suit had expired in two years pursuant to FTCA. This predicament is known as FTCA’s trap for the unwary: see here. Continue reading

Translating “ELSI” into Policy

by Guest Blogger Wylie Burke MD, PhD.

When the Human Genome Project began in 1990, the National Center for Human Genome Research – now the National Human Genome Research Institute (NHGRI) – created a research funding program for evaluation of the ethical, legal, and social implications (ELSI) of genomics. ELSI scholars study a wide range of issues, from the responsible conduct of genomic research, to implementation and outcomes of genetic testing programs, to intellectual property challenges.  But how should this research be evaluated? In particular, what impact should we expect for this kind of research? These questions are particularly challenging for those of us who work in the multidisciplinary Centers of Excellence in ELSI Research (CEERs) funded by the NHGRI, because these centers have been given a programmatic charge to consider policy-relevant questions and help to inform the policy-making process. A group of ELSI researchers, representing seven CEERs, have been deliberating these questions and recently published a paper with recommendations.

We noted, first of all, that policy-making occurs in many venues. Although discussions often focus on governmental policies, policy-making in other venues often influences genomic translation, including actions as diverse as Institutional Review Board (IRB) decisions about consent and return of results; guidelines promulgated by professional organizations; funding decisions of health insurers; and investment decisions of venture capital.   In addition, policy-making in one arena may influence the need for policies in another. For example, practice guidelines influence the use of genetic testing and may in turn influence how clinical data are accessed to evaluate test outcomes, or how IRBs decide what genetic results should be returned to research participants. Continue reading

Call for Submissions: Journal of Law and the Biosciences

JLB coverCall for Submissions: Journal of Law and the Biosciences

Deadline: Rolling.

The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.

JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.

For more information about JLB, click here. To submit a manuscript, click here.

Big Data, Predictive Analytics, Health Care, Law, and Ethics

Update: The Moore Foundation has generously paid to make my article available as open access on their website here. Today I am speaking at Health Affairs’ “Using Big Data to Transform Health Care” in DC, that will also launch its new issue devoted to the topic. I have a co-authored paper in the volume entitled “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care” that has just been released. Ironically the article is behind a paywall (while data wants to be free, I guess big data is different!) Here is the abstract.

Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.

I will also have a related paper on mobile health coming out later this summer that I will blog about when it comes out…

Art Caplan: Facebook Experiment Used Silicon Valley Trickery

Art Caplan has a new opinion piece on NBCNews about a recently published study in The Proceedings of the National Academy of Sciences, where a  Facebook scientist teamed up with two academics to subtly tweak the news feeds of nearly 700,000 Facebook users.

From the piece:

“The question of whether or not an experiment is ethical hinges upon the question of “informed consent.” Generally, this means that a subject in a study needs to have basic information about the study he’s participating in, understand the nature of the experiment and its risks and benefits, and have the ability to withhold his consent without fear of harm or retribution.

The authors of the study argue that they obtained subject consent: Their manipulation of Facebook users’ emotions was “… consistent with Facebook’s Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research.” This is nonsense; it’s not informed consent. It is an old Silicon Valley trick for systematically eliminating the legal rights of its customers.”

Read the full article.

Justice Breyer and Wheaton College v. Burwell

By Gregory Curfman

Tom Goldstein, Publisher of SCOTUSblog, has opined on why Justice Stephen Breyer apparently joined the majority opinion in Wheaton College v. Burwell, which the Court released last Thursday. The majority granted Wheaton a temporary injunction exempting the College from the contraceptive mandate, which was spawned by the Affordable Care Act and which the College claimed violates its religious principles. The vote was 6 to 3, with Justice Scalia filing a concurrence (agreeing “in the result”) and Justices Sotomayor, Ginsburg, and Kagan issuing a forceful dissent. The opinion was unsigned, leaving ambiguous whether Justice Breyer actually did join the majority, though the numbers leave little doubt that he did.

Tom Goldstein believes that Justice Breyer joined the majority because, in doing so, he gained more than he lost. In addition to granting the College an injunction, the majority opinion also states that nothing in the opinion prohibits the government from taking steps to provide women access to contraceptive agents without a copayment. The specific language in the opinion is:

“Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provision of full contraceptive coverage under the Act.”

Thus, Tom Goldstein believes that in joining the majority, Justice Breyer accomplished the pragmatic objective of preventing the loss of contraceptive coverage for the nation’s women who are employed by nonprofit organizations.

Without comment from Justice Breyer himself, we of course cannot know why he (presumably) joined the majority in Wheaton College v. Burwell, despite the fact he dissented when the Court granted Wheaton College a brief (two-day) injunction earlier in the week. And despite the fact that he also joined Justices Ginsburg, Sotomayor, and Kagan in issuing a very strong dissent in Hobby Lobby v. Burwell. Continue reading

Informed consent in social media research

Guest post by Winston Chiong, MD, PhD

Cross-posted from Geripal

facebook research ethics

I’m simultaneously a behavioral researcher, an ethicist, and a hopeless Facebook addict, so I’ve been thinking a lot about last week’s controversial study (Kramer et al, PNAS 2014) in which researchers manipulated the emotional content of 689,003 Facebook users’ News Feeds. In summary, users who saw fewer of their friends’ posts expressing negative emotions went on to express more positive and fewer negative emotions in their own posts, while users who saw fewer posts expressing positive emotions went on to express more negative and fewer positive emotions in their posts.

This provides evidence for “emotional contagion” through online social networks—that we feel better when exposed to other people’s positive emotions, and worse when exposed to negative emotions. This finding isn’t obvious, since some have suggested that seeing other people’s positive posts might make us feel worse if our own lives seem duller or sadder in comparison.

The journal and authors clearly did not anticipate a wave of online criticism condemning the study as unethical. (Full disclosure: one of the authors is also a researcher at UCSF, though I don’t think I’ve ever met her.) In particular, the authors claimed that participants agreed to Facebook’s Data Use Policy when they created their Facebook accounts, and this constituted informed consent to research. Looking at the Common Rule governing research on human subjects, it’s clear that the requirements of informed consent (including a description of the purposes of the research, expected duration, risks/benefits, compensation for harms…) are not met just because subjects click “Agree” to this sort of blanket terms of use. There are exceptions to these requirements, and some people have suggested that the research could have qualified for a waiver of informed consent if the researchers had applied for one. I’m not so sure about that argument, and in any case the researchers hadn’t.

While the online discussion about this study has been fascinating, I think there are a few points that haven’t received as much attention as I think they deserve:  Continue reading

In the Aftermath of Hobby Lobby

By Gregory Curfman and Holly Fernandez Lynch

[A quick follow up to our recent NEJM Perspective on the case, with I. Glenn Cohen]

Immediately after Justice Samuel Alito’s announcement on June 30 of the majority opinion in Burwell v. Hobby Lobby, the Supreme Court took further actions on the contraceptive mandate, and both supporters and opponents of the opinion were furiously assessing the implications and impact of what has proved to be a wild week for women’s access to contraception.

A report from the IMS Institute last April found that 24 million more prescriptions for oral contraceptives without a copayment were written in 2013 (when the contraceptive mandate was in full effect) than in 2012 (when it was not). This translates into a savings of $483 million for women (on average $269 per person). The percentage of women with no out-of-pocket costs for contraceptives increased from 14% to 56%. What will be the impact of the Supreme Court’s decision in Hobby Lobby on these trends?

The Hobby Lobby opinion is quite clear that the contraceptive mandate, spawned by the Affordable Care Act, may not be enforced against closely held, for-profit companies with religious objections to paying for contraceptives coverage. In other words, such companies will not face the hefty fines for noncompliance that would otherwise be imposed by the Department of Health and Human Services.

Nonprofit Organizations

The opinion does not, however, apply to religious-affiliated, nonprofit organizations, such as Catholic schools or religious charities. For such organizations that object to paying for contraceptives coverage, the applicable regulation provided an accommodation by which the entities themselves were off the hook, but instead their insurers (or in the case of self-insured organizations, a third party administrator) would be required to provide free contraceptives coverage without cost to either the employee or the employer.  In order to be eligible for this accommodation, the nonprofit entity must complete a form designating its objection and provide a copy to its health insurance issuer or a third party administrator. A number of nonprofits filed lawsuits asking that they be exempt from even this requirement, on the grounds that they were still being required to violate their religious beliefs by deputizing someone else to provide the objectionable services. One such group, the Little Sisters of the Poor in Colorado, a group of nuns who perform charity work, was granted an injunction by the Supreme Court last January.

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Medicare Coverage for Sex Change Therapy: What’s Next

Last month Medicare’s policy on coverage for sex change therapy changed somewhat. (See Matt’s earlier post here.) Specifically, Medicare’s Departmental Appeals Board invalidated the long-standing National Coverage Determination that dubbed sex change therapy to be non-covered, per se.

Co-blogger Elizabeth Guo and I have done some further digging on this issue and put together two posts answering some questions left open by Medicare’s decision and the news coverage surrounding it.  In this post we discuss next steps: what the change in coverage policy means for Medicare beneficiaries who want coverage for sex change therapy, and what, if any, additional developments are likely to follow.  In a companion post, we will be discussing the somewhat unusual process that was used to make this policy change.

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Religious Freedom and Access to Health Care

SCOTUSfrontCheck out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman.  We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space.  We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.

Take a look and let us know what you think!

Open Clinical Ethics Positions at Boston Children’s Hospital

Interested candidates should apply at www.childrenshospital.jobs.

 Temporary Clinical Ethicist

The Clinical Ethicist provides formal and informal ethics consultations and collaborates with clinical teams, patients and families, managers, and consultants to address ethical issues in pediatric health care and research. Documents ethics activities. May participate in clinical ethics rounds and other educational activities.

Requires working knowledge of theories, principles and concepts typically acquired through completion of a graduate degree in ethics, bioethics, or moral philosophy; a working knowledge of health care and hospitals or clinical degree in a health professional field; and extensive experience in clinical bioethics, preferably in hospital or health delivery systems. Work requires excellent interpersonal, organizational, oral and written communication skills in order to mediate moral disagreements or concerns and develop consensus, compromises, or other ethically acceptable resolutions. Work requires sensitivity in speaking with parents, patients, staff and others in stressful circumstances, in discussing ethical decisions regarding life support, dying and death, disclosure of bad news, participation in research, organ donation and transplantation, and other potential conflicts of interest and values. Work requires demonstrated ability in multidisciplinary collaboration and the ability to initiate, prioritize, and manage multiple projects, working across multiple departmental lines of authority and accountability and under pressure to meet deadlines.

 Clinical Ethicist

Provides formal and informal ethics consultations.  Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.

Work requires at least 5 years clinical inpatient experience in a staff physician or nursing role with substantial prior ethics education and experience derived from completion of an ethics fellowship or other advanced ethics training and/or significant ethics consultation experience.  Preference for a clinical degree in a health professional field and graduate level preparation in this discipline, clinical ethics fellowship completion, graduate degree in bioethics or related field, a strong understanding of acute care pediatric health care, and five or more years of experience in clinical bioethics, preferably in a pediatric hospital or health delivery system. Significant focus on inpatient pediatric ethics consultations with active collaboration with nursing, social work, medical staff, and other internal and external individuals and groups.

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