CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

Honing the Emerging Right to Stop Eating and Drinking

By Norman L. Cantor

A stricken medical patient has a well-established right to reject life-extending medical interventions.  A person afflicted with pulmonary disease is entitled to reject a respirator, a person with kidney dysfunction can reject dialysis, and a person with a swallowing disorder can reject artificial nutrition and hydration (ANH).  State and federal courts uniformly invoke competent patients’ interests in self-determination and bodily integrity to uphold a patient’s prerogative to shape their own medical course.  The patient’s right extends not just to intrusive machinery, but also to simplistic, non-burdensome medical intrusions like an I.V. tube or a blood transfusion.

Some patients facing fatal or seriously degenerative conditions seek to hasten their demise by voluntarily stopping eating and drinking (VSED) before the stage of decline when they are dependent on life-sustaining medical intervention.  They see SED as a way to shorten their ordeal by precipitating death by dehydration within 14 days while receiving mild palliative intervention to foreclose distress before slipping into a terminal coma. The SED process entails days of lingering incapacity and is a distasteful prospect for some patients.  But it is regarded by other patients as a relatively quick, peaceful, and humane way of ending a mortal struggle now deemed to be intolerably arduous.

Numerous medico-legal commentators, myself included,[1] have asserted that a stricken patient has “a right” to VSED.   These commentators associate a patient’s decision to cease nutrition and hydration with the established constitutional right to reject life-sustaining medical intervention.  They note that the fasting person is invoking bodily integrity – precluding any feeding spoon from penetrating their mouth or nutritional tube from being inserted into their body – as well as autonomy in shaping a response to a serious affliction.   They also observe that the proffered succor (in the form of forced feeding or artificial nutrition) demands medically skilled intervention generally subject to a competent patient’s control.

The formal legal authority is thin.  Commentators point to several lower court decisions where judges refused to authorize medical override of a fasting patient.  No high level judicial body has spoken to the precise issue. Continue reading

The Competing Identities of Neuroethics

By Brad Segal

This past week week I attended the International Neuroethics Society’s (INS) annual conference in San Diego, California. Neuroethics is multidisciplinary field that grapples with the implications of neuroscience for—and from—medicine, law, philosophy, and the social sciences. One of the many excellent panels brought together scholars from each of these four disciplines to discuss the diverse approaches to the field. The panel featured; Paul Appelbaum, a Professor of Psychiatry at Columbia University; Tom Buller, Chair of philosophy at Illinois State University; Jennifer Chandler, Professor of law at the University of Ottawa, and; Ilina Singh, Professor of Neuroscience & Society at the University of Oxford.

The panel started by considering the importance of the “competing identities” present in the field of neuroethics. As moderator Eric Racine explained, right from the start, even the term ‘neuroethics’ suggests a tension. Consider the variety of research methodologies employed in the field. For instance, a scholar trained in philosophy might approach neuroscience from a conceptual and purely analytical basis, and yet a social scientist might research the same question by collecting empirical interview data. The interplay between empirical and theoretical work was a theme that defined the discussion.

A psychiatrist by training, Dr. Applebaum spoke on the medical approach to the field. He argued that a focus on ethical issues in clinical psychiatry and neurology should be viewed as a part (but only a part) of neuroethics. Furthermore, medicine’s empirical approach to neuroethics is one (but not the only) way to advance thinking on neuroethical issues. Continue reading

Code Red

By Gregory M. Lipper

“Not Just Obamacare: Medicaid, Medicare Also On GOP’s Chopping Block,” write Jonathan Cohn and Jeffrey Young in The Huffington Post:

Donald Trump and Republican leaders in Congress have made clear they are serious about repealing Obamacare, and doing so quickly. But don’t assume their dismantling of government health insurance programs will stop there.

For about two decades now, Republicans have been talking about radically changing the government’s two largest health insurance programs, Medicaid and Medicare.

Check out the full, detailed article here.

Greg Lipper (@theglipper) is a partner at Clinton Brook & Peed and the former Senior Litigation Counsel at Americans United for Separation of Church and State.

TOMMOROW (11/16)! Book Launch: Nudging Health – Health Law and Behavioral Economics

display-nudging-healthBook Launch: Nudging Health – Health Law and Behavioral Economics
November 16, 2016 12:00 PM
Wasserstein Hall, Milstein East BC (2036)
1585 Massachusetts Ave., Cambridge, MA

In November 2016, Johns Hopkins University Press will publish Nudging Health: Health Law and Behavioral Economics, co-edited by Petrie-Flom Center Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and Christopher T. Robertson, Professor of Law and Associate Dean for Research and Innovation, James E. Rogers College of Law, the University of Arizona. This edited volume stems from the Center’s 2014 annual conference, which brought together leading experts to build on the success of the behavioral economics movement in order to further develop scholarly discussion of key issues in health law policy, bioethics, and biotechnology by addressing both broad conceptual questions and more specific policy applications.

Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics—but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Panelists will discuss some of the issues addressed in the book: Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform.

Panelists:

Continue reading

“That I Don’t Know”: The Uncertain Futures of Our Bodies in America

By Wendy S. Salkin

I. Our Bodies, Our Body Politic

On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews. Here is an excerpt from that event:

MATTHEWS: Do you believe in punishment for abortion, yes or no as a principle?
TRUMP: The answer is that there has to be some form of punishment.
MATTHEWS: For the woman.
TRUMP: Yeah, there has to be some form.
MATTHEWS: Ten cents? Ten years? What?
TRUMP: I don’t know. That I don’t know. That I don’t know.

Much has been made of the fact that President-Elect Trump claimed that women who undergo abortion procedures should face “some sort of punishment.” Considerably less has been made of the fact that our President-Elect, in a moment of epistemic humility, expressed that he did not know what he would do, though he believed something had to be done. (He later revised his position, suggesting that the performer of the abortion rather than the woman undergoing the abortion would “be held legally responsible.”)

I am worried about the futures of our bodies, as, I think, are many. That a Trump Presidency makes many feel fear is not a novel contribution. Nor will I be able to speak to the very many, and varied, ways our bodies may be compromised in and by The New America—be it through removal from the country (see especially the proposed “End Illegal Immigration Act”), removal from society (see especially the proposed “Restoring Community Safety Act”), or some other means (see especially the proposed “Repeal and Replace Obamacare Act”).

But, I am like President-Elect Trump in this way: Like him, “I don’t know.” I don’t know what to say about what will happen to our bodies or to our body politic. So instead, today, I will take this opportunity to point to one aspect of the changing face of access to reproductive technologies that has already become a battleground in the fight over women’s bodies and will, I suspect, take center stage in the debate over the right and the ability to choose in coming years. Continue reading

New Tech, New Rules: Organoids and Ethics at the CJEU

Introduction

Last week, while attending a conference, organized by the Petrie-Flom Center in conjunction with a number of other Harvard institutions, on the ethics of early embryo research and the future of the 14-day rule, I was struck by the presentations on recent developments in stem cell technology. The speakers outlined fascinating developments in human brain organoids. And, since my own cranial organoid is becoming increasingly single track, I started wondering about the potential patentability of such inventions.

An intestinal organoid grown from Lgr5+ stem cells

An intestinal organoid grown from Lgr5+ stem cells

By way of very brief explanation, a human brain organoid is a structure of cells created in vitro through the stimulation of human stem cells. A recent paper has concluded that, given the right conditions for their development, these cell cultures can grow to resemble a 20 week-old human brain in vivo in a number of important respects.

At the conference, Dr John Aach, of the Department of Genetics at Harvard Medical School highlighted the potential of these technologies to form the basis of innovative research and treatments. However, he also highlighted new ethical questions posed by them. In particular, (and I fear I may be grossly oversimplifying his much more subtle presentation) he noted that a sufficiently developed human brain organoid might have the capacity to feel pain. Such technologies might fall to be regulated alongside human embryos created for research. In most jurisdictions, developing an embryo beyond 14 days of gestation is prohibited, whether by law or soft regulation. The rule originally struck a balance between the interests of research and the demands of ethics: day 14 usually marks the appearance of the primitive streak in an embryo and presents a convenient point to place an ethical limitation on research.  Dr Aach noted, however, that a brain organoid does not fall under the traditional definition of embryo. As such, its development is not necessarily subject to the 14-day rule. And yet, the creation of a clump of cells that feels pain is clearly a cause for ethical concern. He argued that the time has come to re-examine the rule in light of technological advancements like organoids. Its replacement, he argued, should not be based on canonical limits but on the underlying moral concerns. Continue reading

Understanding Financial Toxicity

By Zack Buck

In the ongoing fight to control the cost of health care, new understanding of the phenomenon of financial toxicity could play a vital role.  Seen currently in the long-term cancer context, recent studies (here and here, and discussed here and here) have shown that individuals experiencing financial distress as a result of the cost of their care experience higher rates of mortality than those who do not.

In a forthcoming article in the Boston College Law Review (draft here), I make the argument that, following these groundbreaking studies, a new understanding of financial toxicity could transform clinical decision-making.  Indeed, a doctor’s examination of the impact of cost on the patient before deciding to rely on an expensive drug (particularly where a cheaper clinical equivalent exists) could serve as an important tool in limiting the worst effects of expensive care.  And treating cost as a negative side effect (like any other negative side effect) may allow for an explicit awareness and consideration of cost—something too often missing from health care decision-making today.

Health Equity in Housing Book Club: “Knocking on the Door”

Q&A with Christopher Bonastia, PhD

This is the first in a series of posts we will share during our research for our housing equity project. Have a suggestion for what we should read next? Let us know.

In his 2006 book, Knocking on the Door: The Federal Government’s Attempt to Desegregate the Suburbs, Christopher Bonastia, PhD, reviews the federal government’s role in perpetuating residential segregation in the United States, and its fleeting attempts to desegregate the nation’s neighborhoods.

Dr. Bonastia discusses the active role federal agencies and courts have played in creating and perpetuating residential segregation. He points to the Home Owners’ Loan Corporation, the Federal Housing Administration, the Veterans Administration, and the US Department of Housing and Urban Development as significant players in segregation and desegregation.

Understanding the roots of segregation and policy attempts to desegregate is key to understanding housing as a social determinant of health. Empirical research has shown associations between black-white segregation and an increased black infant mortality rate, elevated rates of black mortality, black homicide rates, and other negative individual and public health outcomes. Addressing racial residential segregation is imperative when attempting to improve any of those health outcomes.

Christopher Bonastia is professor of sociology at Lehman College and the City University of New York Graduate Center, as well as associate director of the Lehman Scholars Program and Macaulay Honors College at Lehman. He is the author of Southern Stalemate: Five Years without Public Education in Prince Edward County, Virginia as well as Knocking on the Door: The Federal Government’s Attempt to Desegregate the Suburbs.

Our team read Knocking on the Door during our initial research period on housing, health equity and legal levers. Continue reading below for our interview with Dr. Bonastia about this book and ongoing research in this area.

Continue reading

Jill Fisher on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5

Our guest this week is Jill A. Fisher, Ph.D., Associate Professor of Social Medicine at UNC-Chapel Hill. Jill is a social scientist with a Ph.D. in Science and Technology Studies from Rensselaer Polytechnic Institute and expertise in medical sociology. Her research interests include social studies of the pharmaceutical industry, clinical trials, political economy, healthcare and social inequalities, and research ethics.

Our lightning round discussed Timothy Jost’s go-to piece on the election, “Day One And Beyond: What Trump’s Election Means For The ACA.” Sarah Kliff also writes on four routes to repeal.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Standards, Data Exchange and Intellectual Property Rights in Systems Biology

I am happy to announce that our recent paper on “Standards, Data Exchange and Intellectual Property Rights in Systems Biology” has been accepted for publication in the Biotechnology Journal.  The paper was co-authored by Esther Van Zimmeren from the University of Antwerp, Berthold Rutz from the European Patent Office and me. Please find a summary below:

Intellectual property rights (IPRs) represent a key concern for researchers and industry in basically all high-tech sectors. IPRs regularly figure prominently in scientific journals and at scientific conferences and lead to dedicated workshops to increase the awareness and “IPR savviness” of scientists. In 2015, Biotechnology Journal published a report from an expert meeting on “Synthetic Biology & Intellectual Property Rights” organized by the Danish Agency for Science, Technology and Innovation sponsored by the European Research Area Network (ERA-Net) in Synthetic Biology (ERASynBio), in which we provided a number of recommendations for a variety of stakeholders. The current article offers some deeper reflections about the interface between IPRs, standards and data exchange in Systems Biology resulting from an Expert Meeting funded by another ERA-Net, ERASysAPP. The meeting brought together experts and stakeholders (e.g. scientists, company representatives, officials from public funding organizations) in systems biology (SysBio) from different countries.  Despite the different profiles of the stakeholders at the meeting and the variety of interests, many concerns and opinions were shared. In case particular views were expressed by a specific type of stakeholder, this will be explicitly mentioned in the text. This article reflects on a number of particularly relevant issues that were discussed at the meeting and offers some recommendations. Continue reading

CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

THIS AFTERNOON! (11/7): The Ethics of Early Embryo Research & the Future of the 14-Day Rule

egg cells flowing in a blue background

The Ethics of Early Embryo Research & the Future of the 14-Day Rule
November 7, 2016 3:00 – 6:30 PM
Austin Hall, North Classroom (100)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA
 

Description

For over 35 years, the “14-Day Rule,” prohibiting in vitro experimentation on embryos beyond 14 days, has stood as an ethical line in the sand for embryo research around the world. Throughout the arc of the rule’s existence it has not been questioned, as scientists have been unable to grow embryos in vitro either up to, or beyond, 14 days; a practical limitation that served as a backstop to the ethical rule. However, in May of this year, labs in the U.S. and the U.K. were the first to report being able to sustain human embryos in vitro for up to 13 days. This development and other advances in in vitro research involving organized, embryo-like cellular structures have raised a number of questions about the rule, its genesis, application, and future scope. This conference will convene experts in bioethics, stem cell research, embryology, and law to discuss the ethical underpinnings and future scope of the rule. Questions to be discussed include:

  • What are the historical, ethical and scientific rationales for establishing the 14-Day Rule?
  • Should the 14-Day Rule be revisited in light of recent advances?
  • Should the 14-Day Rule even apply to research involving the in vitro culture of embryo-like cellular structures?

Agenda Continue reading

Health Insurance, Veterinary Care, and the Not-So-Secret Benefits of Pets

By Shailin Thomas

Pet ownership is incredibly popular in the United States. There are almost 70 million companion dogs spread across 43 million American households.   This isn’t particularly surprising, given that study after study has shown that companion animals promote healthier, happier, longer lives for their owners. Despite pet popularity and prevalence, though, many pet owners don’t fully understand how expensive their four-legged family members can be — especially if they end up needing extensive veterinary care. Every year, millions of companion animals are euthanized because their owners lack the financial resources to pay for necessary veterinary services. Unlike in human medicine, pets in the hospital with readily curable ailments often go untreated for financial reasons.

How can we help people keep and care for their pets — capturing companion animal health benefits while also ensuring those pets receive the veterinary care they need? The answer might be found in the synergies between animal and human health — and the benefits they entail for health insurance providers.

The health benefits of companion animals have been extensively documented in both the scientific literature and the mainstream media. Pet owners have, inter alia, decreased risk of cardiovascular disease, decreased risk of anxiety and depression, decreased incidence of allergies, and increased immune system function. Some insurance companies even have materials for their customers promoting pet ownership because of these benefits. The health conditions ameliorated by animal companionship are often otherwise treated with doctor’s visits, medications, and other expensive interventions paid for in large part by insurance providers. In other words, pet ownership produces positive externalities on insurance providers by decreasing the amount they pay in traditional medical services for these ailments — and insurance companies have an interest in incentivizing animal companionship.

Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of October. The selections feature topics ranging from the failure of investigational drugs in late-stage clinical development, to the impact of Medicaid expansion on health care utilization, to impact of a bundled Medicare reimbursement policy on major adverse cardiovascular events among dialysis recipients. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Dafny LS, Ody CJ, Schmitt MA. Undermining Value-Based Purchasing – Lessons from the Pharmaceutical Industry. N Engl J Med. 2016 Oct. [Epub ahead of print]
  2. Doshi P. Is this trial misreported? Truth seeking in the burgeoning age of trial transparency. 2016;355:i5543.
  3. Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA Intern Med. 2016 Oct. [Epub ahead of print]
  4. Kesselheim AS, Avorn J. Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy. 2016 Oct. [Epub ahead of print]
  5. Sommers BD, Blendon RJ, Orav EJ, Epstein AM. Changes in Utilization and Health Among Low-Income Adults After Medicaid Expansion or Expanded Private Insurance. JAMA Intern Med. 2016;176(10):1501-9.
  6. Tominaga T, Miyazaki S, Oniyama Y, Weber AD, Kondo T. The Japanese Postmarketing Adverse Event Relief System: A confluence of regulatory science, the legal system, and clinical pharmacology. Clin Pharmacol Ther. 2016 Oct. [Epub ahead of print]
  7. Wang C, Kane R, Levenson M, Kelman J, Wernecke M, Lee JY, Kozlowski S, Dekmezian C, Zhang Z, Thompson A, Smith K, Wu YT, Wei Y, Chillarige Y, Ryan Q, Worrall C, MaCurdy TE, Graham DJ. Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare. JAMA Intern Med. 2016 Oct. [Epub ahead of print]

Monday, 11/7, HLS Health Law Workshop with Trudo Lemmens

November 7, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “While Canada Ventures into Legalized Medical Assistance in Dying, What Can It Learn from the Belgian Euthanasia Experience?”

To request a copy of the paper in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Trudo Lemmens is Professor and Scholl Chair in Health Law and Policy at the University of Toronto Faculty of Law. He holds cross appointments in the Faculty of Medicine, and the Joint Centre for Bioethics. Since joining the Faculty of Law, he has been a member of the School of Social Science of the Institute for Advanced Study in Princeton, a visiting fellow of the Royal Flemish Academy of Belgium for Science and the Arts, a visiting professor at the K.U.Leuven and the University of Otago (New Zealand), a Plumer Visiting Fellow at Oxford’s St. Anne’s College, and an academic visitor at the Faculty of Law and the HeLEX Center for Health, Law and Emerging Technologies at the University of Oxford.

Lemmens holds a Licentiate of Laws (LL.Lic.) from the KU Leuven (Belgium) and both a Master of Laws (LLM, specialization bioethics) and Doctorate of Civil Law (DCL) from McGill University. His research sits at the interface of law, ethics, and professional governance. Currently, his research focuses on the complex interaction between law, other governance tools, and ethical norms and values in the context of health care, biomedical research, health product development, and knowledge production.

Lemmens’ publications include the co-authored book Reading the Future? Legal and Ethical Challenges of Predictive Genetic Testing, the co-edited volume Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability, as well as numerous chapters and articles in national and international law, policy, science, medicine and bioethics journals. He is currently a member of the Advisory Committee on Health Research of the Pan American Health Organization and of the Board of the Ontario Mental Health Foundation.

Legal Levers for Health Equity through Housing: A New Research Project

Health equity in housing can be defined as the absence of disadvantage to individuals and communities in health outcomes, access to health and social services, and quality of health and social services based on a person’s dwelling or neighborhood.

Lack of housing access, poor housing conditions, and income or racial segregation all have been shown empirically to cause negative health outcomes. Law has a pervasive role in housing, and has for a long time. Law was instrumental in creating and maintaining segregation through mechanisms like red-lining, restrictive covenants and zoning. The Civil Rights movement brought an end to explicitly discriminatory policies, and new finance and inclusionary zoning policies helped create millions of units of affordable housing, but we still have a long way to go. As Matthew Desmond’s work shows, drastic improvements are needed in how governments enforce housing codes and balance the rights of landlords and tenants. The bottom line is that too many of our people have trouble affording decent housing in neighborhoods with the amenities for healthy living, and too many of our neighborhoods are still segregated.

Our team at the Center for Public Health Law Research has been selected as a research hub in the Robert Wood Johnson Foundation’s Policies for Action Program. For the next 20 months, we will be using empirical research and legal scholarship to analyze the housing crisis through the lens of law. We know that law shapes environments and behaviors, so we are searching for the links between laws, their intended and unintended effects on the housing market, and the health outcomes that follow. We will be bringing a focus on law and its mechanisms to a field rich in policy research. Our aim is to investigate how law influences health equity in housing, and offer recommendations about how it can be a lever for greater equity. We hope to engage the community of non-profits, advocacy groups, policy think-tanks, and social scientists who are working on identifying problems and finding solutions, as well as the community of legal scholars and litigators working on housing issues. In our recommendations we plan on both identifying steps to incrementally advance housing equity through existing law, and envisioning creative changes to the legal framework itself.

We are excited to engage the housing policy and the law community in a discussion about legal levers for health equity through housing. We also look forward to sharing our work with you as we go, here and on the Policies for Action website. Please stay tuned!

If you are interested in continuing this discussion please reach out to Abraham Gutman at Abraham.gutman@temple.edu

Russell Korobkin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5For our Diamond Podcast, our guest is Russell Korobkin, Vice Dean and Richard C. Maxwell Professor of Law at UCLA School of Law, where he teaches ContractsNegotiation and Health Care Law. Russell has published more than 50 law journal articles in the fields of behavioral law and economics, negotiation and alternative dispute resolution, contract law, the health care law and stem cell research, and has also published several books.

In the lightning round, Nic focused on the AARP’s challenge to wellness programs, and further empirical research on the Oregon experiment. Frank discussed news coverage of past guest Ameet Sarpatwari’s work, and a study on the use of scribes to promote better data gathering and analysis (and relieve physician burnout). Continue reading

TOMORROW, 11/2! The 21st-Century Advanced Illness Care Team: How Team-based Care is Moving Medicine Beyond the Clinic into the Home and Community

The 21st-Century Advanced Illness Care Team: How Team-based Care is Moving Medicine Beyond the Clinic into the Home and Community
November 2, 2016 12:00 PM
Pound Hall, Room 101
Harvard Law School, 1563 Massachusetts Ave., Cambridge, MA

Care for advanced illness is moving beyond the hospital and physician office and into the home and community. Addressing the needs of the individual with advanced illness increasingly requires an interdisciplinary team of providers, with significant policy implications.

This panel discussion will feature voices across specialties and professions addressing clinical and policy solutions.

Speakers:

  • Cheryl Sullivan, Chief Executive Officer, American Academy of Nursing
  • Sandra Schellinger, Senior Scientist, Late Life Supportive Care Research, Allina Health System
  • Brad Stuart, Chief Medical Officer, Coalition to Transform Advanced Care
  • Ravi Parikh, Clinical Fellow, Harvard Medical School, Resident in Internal Medicine, Brigham and Women’s Hospital
  • Mark Sterling, Senior Fellow, Project on Advanced Care and Health Policy at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

This event is free and open to the public. Lunch will be provided.

Part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care(C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School focused on development and spread of effective person-centered models of advanced illness care through interdisciplinary analysis of important health law and policy issues.

Organs and Overdoses (Part II): ‘Higher risk’ donors

By Brad Segal

In my last post I characterized how overdoses from the surging opioid epidemic have become the fastest-growing cause of mortality among organ donors. In this update, I raise one potential consequence with ethical and policy implications: so-called donor-derived infections. To be clear, I focus primarily on organ recipients as deaths from drug overdose, and drug addiction more broadly, should be prevented regardless of any implications for transplantation. With this in mind, consider how the population of injection drug users shoulders a heavy burden of HIV, hepatitis B (HBV) and hepatitis C (HCV) (Table 1). First I will focus on screening guidelines, and then will move on to transplantation of organs known to carry an infection. table-1

Screening guidelines can help reduce the incidence of donor-derived infections, but the lab tests recommended in any policy must balance two potential concerns. First, lab tests have a rate of false negative results. Transplants of these organs will accidentally increase donor-derived infections. The policy question, then, is whether or not transplanting organs donated by individuals with higher risk of recent disease exposure will expose an unacceptable proportion of recipients to infection. This unintentional harm could undermine a duty of non-maleficence to organ recipients. Further complicating a potential screening policy is that the basic lab tests for HIV, HBV, and HCV detect the presence of human antibodies, which work well among a low-risk population, but antibodies might not appear in the blood until weeks after infection (Table 2).Recent infections are better detected by nucleic acid amplification (NAT) testing.To mitigate risk of infection,then, transplant screening policies should require a heightened level of surveillance among donors with a history of illicit drug use. Continue reading