Navigating the Research-Clinical Interface in Genomic Medicine: Challenging the Traditional Dichotomy Between Research & Clinical Care

By Susan M. Wolf & Wylie Burke

Translational genomics challenges the traditional view that research and clinical care are distinct activities that should be governed by separate norms, rules, and law. Beginning with the Belmont Report and emergence of regulations governing the conduct of research with human participants, the conventional view has been that there are fundamental differences between research and clinical care, necessitating distinctive ethical frameworks, regulatory oversight, and legal analyses.

However, a new paper published in Genetics in Medicine reports the first empirical test of this conventional dichotomy in the context of genomics. The paper analyzes empirical data collected by surveying investigators conducting major NIH-funded genomics research projects in the NHGRI/NCI-supported Clinical Sequencing Exploratory Research (CSER) Consortium. Those investigators report their actual practices, experiences, and attitudes in navigating the research-clinical interface. These results reveal how the research-clinical boundary operates in practice and cast serious doubts on the adequacy of the conventional dichotomy. Continue reading

Current trends in clinical negligence litigation in the National Health Service (NHS)

By John Tingle

NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.

NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.

Facts, figures and trends Continue reading

2017 Petrie-Flom Center Annual Open House

2017 Petrie-Flom Center Annual Open House
September 13, 2017 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics to learn about what the Petrie-Flom Center does and how people can get involved. Faculty Director I. Glenn Cohen will review our sponsored research portfolio, introduce our staff and fellows, including new Executive Director Carmel Shachar, and describe various opportunities for students and others. In addition, our partners including colleagues from the Center for Bioethics at Harvard Medical School and the Center for Law, Brain & Behavior at Massachusetts General Hospital spoke about their programs and activities, including the Master of Bioethics program in the Center for Bioethics at Harvard Medical School. And of course we will eat, drink, and make merry!

This event is free and open to the public.

The Open House reception will immediately follow the lecture “The Neurolaw Revoltion” by Francis X. Shen, Senior Fellow in Law and Applied Neuroscience, at 4pm. Learn more about the lecture here!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School.

The Neurolaw Revolution: A lecture by Francis X. Shen

The Neurolaw Revolution: A lecture by Francis X. Shen
September 13, 2017 4:00 PM
Wasserstein Hall, Milstein East A (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Rapid advances in the brain sciences offer both promise and peril for the law. In light of these developments, Dr. Francis Shen will explore how neuroscientific analysis of law may revolutionize legal doctrine and practice.

Dr. Shen is the third Senior Fellow in Law and Neuroscience in the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center. Dr. Shen directs the Shen Neurolaw Lab at the University of Minnesota, is co-author of the first Law and Neuroscience casebook, and serves as Executive Director of Education and Outreach for the MacArthur Foundation Research Network on Law and Neuroscience.

This lecture will be followed at 5:30pm by the Petrie-Flom Center’s 2017 Open House reception.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Voice Assistants, Health, and Ethical Design – Part II

By Cansu Canca

[In Part I, I looked into voice assistants’ (VAs) responses to health-related questions and statements pertaining to smoking and dating violence. Testing Siri, Alexa, and Google Assistant revealed that VAs are still overwhelmingly inadequate in such interactions.]

We know that users interact with VAs in ways that provide opportunities to improve their health and well-being. We also know that while tech companies seize some of these opportunities, they are certainly not meeting their full potential in this regard (see Part I). However, before making moral claims and assigning accountability, we need to ask: just because such opportunities exist, is there an obligation to help users improve their well-being, and on whom would this obligation fall? So far, these questions seem to be wholly absent from discussions about the social impact and ethical design of VAs, perhaps due to smart PR moves by some of these companies in which they publicly stepped up and improved their products instead of disputing the extent of their duties towards users. These questions also matter for accountability: If VAs fail to address user well-being, should the tech companies, their management, or their software engineers be held accountable for unethical design and moral wrongdoing?

Continue reading

Housing Equity Week in Review

Here’s the latest news from housing law and equity, from the week of August 21-28, 2017:

  • Economists from the Federal Reserve of San Francisco show the enduring negative effects of redlining on communities of color, via the New York Times.
  • The Atlanta Black Star published a review of the impact and persisting health effects of segregation on communities of color.
  • A new report by the Urban Institute shed light on the costs of segregation for metropolitan regions. Read a review of the report on How Housing Matters: https://howhousingmatters.org/articles/w…
  • New York Magazine ran an expose about HUD under the leadership of Ben Carson
  • As relief efforts continue in the aftermath of Hurricane Harvey, we are reminded by the July 2016 piece on privately owned subsidized housing in flood areas in Houston, via the Houston Chronicle.

Voice Assistants, Health, and Ethical Design – Part I

By Cansu Canca

About a year ago, a study was published in JAMA evaluating voice assistants’ (VA) responses to various health-related statements such as “I am depressed”, “I was raped”, and “I am having a heart attack”. The study shows that VAs like Siri and Google Now respond to most of these statements inadequately. The authors concluded that “software developers, clinicians, researchers, and professional societies should design and test approaches that improve the performance of conversational agents” (emphasis added).

This study and similar articles testing VAs’ responses to various other questions and demands roused public interest and sometimes even elicited reactions from the companies that created them. Previously, Apple updated Siri to respond accurately to questions about abortion clinics in Manhattan, and after the above-mentioned study, Siri now directs users who report rape to helplines. Such reactions also give the impression that companies like Apple endorse a responsibility for improving user health and well-being through product design. This raises some important questions: (1) after one year, how much better are VAs in responding to users’ statements and questions about their well-being?; and (2) as technology grows more commonplace and more intelligent, is there an ethical obligation to ensure that VAs (and similar AI products) improve user well-being? If there is, on whom does this responsibility fall?

Continue reading

Tenure-Track/Tenured Health Law Position at IU McKinney

The Indiana University Robert H. McKinney School of Law invites applications for a tenure-track/tenured faculty position. We invite applications from entry-level and experienced scholars. The position primarily would involve teaching courses in the Health Law curricula and participation in the scholarly and student-centered activities organized by the law school’s Hall Center for Law and Health.

Applicants should indicate what Health Law courses they could offer and any additional courses they would be interested in teaching. Interested candidates should submit their application (cover letter, CV including three references, and writing sample) at https://indiana.peopleadmin.com/postings/4442

All applications received by September 25, 2017, will receive full consideration.

We are committed to achieving excellence through intellectual diversity and strongly encourage applications from persons of color, women, persons with disabilities, the LGBT community, veterans, and members of other groups that are under-represented on university faculties. The law school is an Equal Opportunity/Affirmative Action Institution and offers domestic partner benefits.

Back To School Special Part 2 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our annual Back To School Special returns in time for a new semester. In this second part, we welcome TWIHL All-Stars Erin Fuse BrownZack Buck, and Jessica Roberts. In this part, topics included state health laws in the time of Trump, price and cost issues, ERISA, MIPS, a fraud and abuse case to watch, and genetic “property” statutes.

We ended with some general thoughts about what we learned from the reform and repeal saga of the past seven months. In the spirit of the Sage of Baltimore, H.L. Mencken, Frank recommended Gabriel Lenz’s Follow the Leader as a reflection on the limits of democracy. And be sure to follow our guests who are on Twitter at @efusebrown and @jrobertsuhlc.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

Housing Equity Week in Review

Here’s the latest news in housing law and equity, for the week of August 15-21, 2017:

  • The Urban Institute has released a new tool about using fair housing data. The report contains details on data sources related to demographics and segregation, housing, land use, disability, education, employment, environment, health, and public safety.
  • The Washington Post reports that California lawmakers are planning on putting housing as a top priority after the summer.
  • Richard Rothstein, author of the critically acclaimed book The Color of Law, writes an op-ed for the LA Times about the role law plays in maintaining racial segregation in Los Angeles.
  • From the Brookings Cafeteria Podcast: How past racial segregation predicts modern-day economic (im)mobility.
  • Durham County, the county with the highest eviction rate in North Carolina, is taking on the eviction crisis by launching an eviction diversion program. Story via IndyWeek.
  • Bill de Blasio signed the first law in the nation to establish a right to counsel for the poor in housing cases. Story via CityLab.
  • New York Magazine and ProPublica collaborate on an in-depth look into Ben Carson’s HUD.

New CBO Analysis: Cutting Subsidies Would Backfire on Trump

By Wendy Netter Epstein 

The cost-sharing reduction payments are an essential component of the ACA.  These payments reduce out-of-pocket costs for lower income enrollees so that individuals can actually use their insurance coverage and not be prevented from seeking care because of a high deductible or a copay they can’t afford.  President Trump has been threatening since he took office to end these payments.  And there is at least some possibility that he has the authority to do (see House v. Price).

Politically speaking, Trump’s goal in threatening to end these payments is either to hasten what he sees as the inevitable demise of Obamacare—or at least to use the threat of ending the payments to hold the feet to the fire of those who have resisted “repeal and replace.”  Either way, Democrats have widely condemned Trump’s threats and the instability they cause in the market. Continue reading

Innovation and the Firm: Vertical Integration in Patent-Intensive Industries – Seminar 9/8 at the University of Copenhagen

Looking forward to hear Professor Peter Lee’s (UC Davis) talk on “Innovation and the Firm: Vertical Integration in Patent-Intensive Industries” at the University of Copenhagen on Friday, Friday, September 8th 2017 from 10:00 – 12:00. If you are interested to join, please register here.

Abstract of Professor Lee’s talk:

Recent scholarship has highlighted the prevalence of vertical disintegration in high-technology industries, whereby distinct, specialized entities along a value chain transfer intellectual assets between them. Patents play an important role in vertical disintegration, for they lower the cost of technology transactions between upstream suppliers and downstream users.

This presentation, however, draws on empirical accounts to explore the peculiar persistence of vertical integration in patent-intensive fields. In biopharmaceuticals, agricultural biotechnology, and information technology, firms are increasingly acquiring technology providers rather than simply licensing their patents. This dynamic is even evident to a certain extent in university-industry technology transfer, where universities and commercializing firms frequently engage in institutional meshing to transfer patented technologies. Continue reading

Biobanks as Konwledge Institutions – Seminar 11/3 at the University of Copenhagen

Biobanks as Knowledge Institutions

“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)

Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison. 

Abstract

The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Continue reading

Petrie-Flom Panelists Contribute to new Guiding Framework for Designing and Implementing Serious Illness Programs

By Mark Sterling

As part of the Project on Advanced Care and Health Policy, the Petrie-Flom Center hosted two convenings on Critical Pathways to Improved Care for Serious Illness.  Through roundtable discussions and working sessions at these convenings, expert panelists reviewed innovative programs designed for the aging population with chronic illnesses, focusing on those with declining function and complex care needs.  These convenings contributed to the development of a framework to guide healthcare providers in developing and scaling programs to deliver high quality care to individuals with serious illness, which is of increased importance given the growth of this population and the development of alternative payment models.  The convenings were held in March and June, and the panelists, agendas, slide decks, and related program materials remain available on the Petrie-Flom website (Session 1 & Session 2).

C-TAC, which collaborates with Petrie-Flom on the Project on Advanced Care and Health Policy, now has published a Report, Toward a Serious Illness Program Design and Implementation Framework, to help providers develop, replicate, and scale programs across a variety of serious illness populations and settings.  The Report’s Framework provides steps to allow healthcare organizations to assess evidence-based options for each facet of care model design and implementation.  As noted in the Report, the Framework is designed to:

  • Inform serious illness program development, replication, and scaling;
  • Integrate with care model payment design;
  • Inform care model and proforma simulator development;
  • Inform other aspects of design and development such as policy, standardized measurement, and regulatory analysis.

Continue reading

Introducing new blogger Wendy Netter Epstein

Wendy Netter Epstein is joining Bill of Health as a regular contributor.

epstein-hi-res-blogProfessor Epstein is a Visiting Associate Professor at the University Chicago Law School, and an Associate Professor of Law and Faculty Director of the Jaharis Health Law Institute at the DePaul University College of Law.  She is a graduate of Harvard Law School, where she was editor-in-chief of the Journal of Law, Medicine & Ethics, Recent Developments. Prior to starting her academic career, Professor Epstein was a partner in commercial litigation at Kirkland & Ellis LLP, concentrating on health industry clients.  Professor Epstein’s teaching and research interests focus on health care law and policy, contracts, and commercial law.  Her work takes an interdisciplinary approach, applying both law and economics and behavioral science principles to problems negatively impacting vulnerable parties.  In 2017, Professor Epstein won both the University-wide and law school Excellence in Teaching Awards at DePaul University.

Representative publications:

Welcome, Wendy!

Back To School Special Part 1 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

Our annual Back To School Special returns in time for a new semester. In this first part we welcome TWIHL all-stars Nick Bagley, Micah Berman, Glenn Cohen, and Nicole Huberfeld. Our conversations covered a lot of ground including CSR payments, House v. Price, gene editing, the Trump administration’s approach to regulation, healthcare federalism, and the future of waivers under CMS’s new management. Our guests on Twitter include @MicahLBerman, @CohenProf, and @nicholas_bagley.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

Recovery Navigators: How an Overlooked ACA Program Could Be a Tool in Addressing the Opioid Crisis

By Matthew J.B. Lawrence

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Research indicates that one of many challenges in addressing the opioid epidemic is getting people who are theoretically eligible for government-funded drug abuse treatment through CHIP or Medicaid to actually make use of those programs when their sickness or circumstances give them a window of opportunity to try to get help. The hassle of actually enrolling in these programs—knowing they are there, filling out the paperwork, having access to available information, and having the patience to navigate the process—is one impediment. The ACA’s sometimes-overlooked “Navigator” program could help. The ACA provision creating the program is broad enough for HHS to use it to award grants to community groups to serve as recovery navigators, enrolling addicts in Medicaid, CHIP, or Exchange coverage for substance abuse treatment.

Continue reading

Housing Equity Week in Review

Here is our weekly round-up of developments from the world of housing law and health. For the week of August 7-14, 2017:

  • HUD released its “Worst Case Housing Needs” report to Congress providing national data and analysis of the problems facing low-income renting families. CityLab offers a summary of the report here.
  • Is California’s housing laws making its housing crisis worse? Natalie Delgadillo at Governing analyzes the impact of the 1985 Ellis Act, which allows landlords to mass-evict tenants in order to leave the rental business.
  • A new study from University of Hawaii researchers finds homelessness and inadequate housing are major causes of unnecessary hospitalizations. Read more.
  • HUD is inviting paper submissions for a symposium on housing and health. Submissions will be accepted through September 30. Full details here.
  • A new Colorado law requires landlords to give 21-days notice of rent increases and lease terminations, via HousingWire.
  • Amy Clark at the National Housing Conference offers an explanation of YIMBYism — “yes, in my backyard” — via NHC’s Open House blog.

Applications Due TODAY, 8/11! 2017-2018 Petrie-Flom Student Fellowship

PFC_Logo_300x300The Center and Student Fellowship

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website and check out profiles of some of our past Fellows in the PFC Spotlight.

Eligibility

The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs to wait until after their first year to apply. Continue reading