NEXT MONTH (10/24): Health Care after the Election

presidential_nominees_slideHealth Care after the Election
October 24, 2016 12:00 PM
Wasserstein Hall, Milstein West AB (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Description

As we approach the 2016 presidential election and change of administration, there are many questions about the future of health policy that the 45th President and Congress will have to address starting in 2017. This event brings together health care experts from both sides of the aisle to discuss what health care will – and should – look like under the next administration.

Possible topics for discussion include:

  • The Affordable Care Act
  • Drug pricing
  • Delivery system reform
  • Innovation and research funding/NIH
  • Mental health
  • Public health

Continue reading

Monday, 9/19, HLS Health Law Workshop with Amy Sepinwall

September 19, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Challenges of Conscience in a World of Compromise”

Amy Sepinwall is Assistant Professor of Legal Studies and Business Ethics and James G. Campbell, Jr. Memorial Term Assistant Professor of Legal Studies and Business Ethics at the Wharton School at the University of Pennsylvania. Her research interests include individual and collective responsibility for corporate and financial wrongdoing, corporate constitutional rights, and gender and racial justice. Prior to joining the faculty at the Wharton School, she clerked for the Honorable Louis H. Pollak, Eastern District of Pennsylvania.

Sepinwall earned her PhD from Georgetown University and her JD from Yale Law School. She also holds MA and BA degrees from McGill University. From 2007 – 2008, she held a Charlotte Newcombe Dissertation Fellowship at the Woodrow Wilson Foundation.

Monday, 9/12, HLS Health Law Workshop with Patricia Zettler

September 12, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: Pharmaceutical Federalism

Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration. Her research focuses on the interaction between state and federal regulation of medicine and science, the challenges that innovation poses for the FDA’s regulatory scheme, and the treatment use of experimental drugs and devices outside of clinical trials. Zettler’s scholarship has appeared or is forthcoming in various legal and medical journals, including the Indiana Law Journal, San Diego Law Review, Yale Journal of Health Policy Law and Ethics, Journal of Law and the Biosciences, Boston University International Law Journal, JAMA Internal Medicine, EMBO Molecular Medicine, and Academic Medicine. Zettler teaches Torts, Health Law: Quality & Access, and Food and Drug Law.

Before joining Georgia State Law in 2015, she was a fellow at the Center for Law and the Biosciences at Stanford Law School. Prior to her fellowship, she served as an associate chief counsel in the FDA’s Office of Chief Counsel, where she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, incentives for developing antibiotics and advisory committees. Continue reading

REGISTER NOW (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 – 6:00 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?

Tentative Agenda Continue reading

NEXT WEEK (9/7): Battling Blood in the Streets Neuroscience Panel, followed by PFC Open House

2016.09.07_battling_blood_for_printBattling Blood in the Streets: How Can Neuroscience Promote Public Health and Support Public Policy to Prevent Community Violence?
September 7, 2016 4:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

 

 

IMMEDIATELY FOLLOWED BY:

15.09.07, 2016 Open House Visix2016 Petrie-Flom Center Annual Open House
September 7, 2016 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

 

 

Battling Blood in the Streets: How Can Neuroscience Promote Public Health and Support Public Policy to Prevent Community Violence?
Far too many people across the country are left dead, injured, or traumatized by community violence. Communities can be safer when neuroscience, public health strategies, and collective advocacy are aligned in practice and policy. What are the best next steps to fostering a broad science-informed advocacy movement to effectively address community violence? Continue reading

CALL FOR ABSTRACTS! 2017 Annual Conference, “Transparency in Health & Health Care: Legal & Ethical Possibilities & 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

Call for Proposals: BioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago, IL.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology, life sciences, food and drug law, and intellectual property (hence, bioip), broadly defined. A Review Committee comprised of faculty from the Boston University School of Law, Georgia State University College of Law, and the Loyola University Chicago School of Law will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience, including VAPS and Fellows, are eligible for participation in the Workshop. Those interested in participating should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at thutchinson@aslme.org by Oct 14, 2016.

Selected abstracts will be announced later in Fall 2016 with the full draft papers due by April 1, 2017. The organizers will cover reasonable travel and lodging expenses for selected scholars.

For questions, please email Cynthia Ho at cho@luc.edu.

NOW AVAILABLE FOR PRE-ORDER! Nudging Health: Health Law and Behavioral Economics

This volume, edited by I. Glenn Cohen, Holly Fernandez Lynch, and Christopher T. Robertson, stems from the Petrie-Flom Center’s 2014 Annual Conference “Behavioral Economics, Law, and Health Policy.” Pre-order your copy today!

Nudging HealthBehavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver’s seatbelt isn’t fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes.

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. 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.

Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues—from the Affordable Care Act to prescription drugs.

Read the introduction on SSRN and pre-order your book now!

NOW ONLINE! Oxford Union Debating Society DNA Manipulation Debate

DNA fingerprints.The Oxford Union Debating Society at Oxford University has published full video of its DNA Manipulation Debate, filmed on May 26. The Motion under debate was, “This House Believes the Manipulation of Human DNA is an Ethical Necessity.” Oxford billed its DNA Manipulation Debate as “historic” in a year when rapid advances in gene editing and genome synthesis suddenly confront humans with the possibility of being able to write, edit, re-write, and ultimately control their own genetic destinies.

The team supporting the Motion was led by Sir Ian Wilmut, famous for cloning Dolly the Sheep and now Chair of the Scottish Centre for Regenerative Medicine at the University of Edinburgh, and included Oxford’s noted moral philosopher Julian Savulescu and Oxford student debater Lynda Troung, a fast-rising star in RNA research.

The team opposing the Motion included Dr. Norman Fost, professor emeritus of pediatrics and director of the medical ethics program at the University of Wisconsin; Professor Barbara Evans, Director of the Center for Biotechnology & Law at the University of Houston Law Center and a frequent participant in Petrie-Flom conferences; and Oxford student debater Dr. Rahul Gandhi, a young medical doctor and monk focusing on rural healthcare, who is pursuing an MBA at Oxford this year as a prelude to seeking an MPH at Harvard next year.

Continue reading

REGISTER NOW! Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but seating is limited. Register now!

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

Continue reading

Radical Redesign of Health Care and Its Implications for Policy: A Lecture by Donald Berwick, MD, Administrator of the Centers for Medicare and Medicaid Services (2010-2011)

stethoscope with puzzleSpecial Lecture to Open ASLME’s 39th Annual Health Law Professors Conference

June 2, 2016, 6:00pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Reception to follow.

Free and open to the public, but seating is limited. Please register for the lecture and reception here.

Introduction by Martha Minow, Morgan and Helen Chu Dean and Professor, Harvard Law School

Moderator: I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School

MAGAZINE- 12/17/03; Boston- Dr. Donald Berwick poses for a portrait at his Boston organization The Institute of Healthcare Improvement. Photo by Laurie Swope (DIGITAL IMAGE)

Donald Berwick, MD, is one of the United States’ leading advocates for high-quality healthcare. From July 2010 to December 2011, he served as the Administrator of the Centers for Medicare and Medicaid Services. For 22 years prior to that, he was the founding CEO – and now President Emeritus and Senior Fellow – of the Institute for Healthcare Improvement, a nonprofit dedicated to improving healthcare around the world. A pediatrician by background, he has also served on the faculties of the Harvard Medical School and the Harvard School of Public Health.

Continue reading

REGISTER NOW: Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but seating is limited. Register now!

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

Continue reading

Radical Redesign of Health Care and Its Implications for Policy: A Lecture by Donald Berwick, MD, Administrator of the Centers for Medicare and Medicaid Services (2010-2011)

stethoscope with puzzleSpecial Lecture to Open ASLME’s 39th Annual Health Law Professors Conference

June 2, 2016, 6:00pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Reception to follow.

Free and open to the public, but seating is limited. Please register for the lecture and reception here.

Introduction by Martha Minow, Morgan and Helen Chu Dean and Professor, Harvard Law School

Moderator: I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School

MAGAZINE- 12/17/03; Boston- Dr. Donald Berwick poses for a portrait at his Boston organization The Institute of Healthcare Improvement. Photo by Laurie Swope (DIGITAL IMAGE)

Donald Berwick, MD, is one of the United States’ leading advocates for high-quality healthcare. From July 2010 to December 2011, he served as the Administrator of the Centers for Medicare and Medicaid Services. For 22 years prior to that, he was the founding CEO – and now President Emeritus and Senior Fellow – of the Institute for Healthcare Improvement, a nonprofit dedicated to improving healthcare around the world. A pediatrician by background, he has also served on the faculties of the Harvard Medical School and the Harvard School of Public Health.

Continue reading

BioData World Congress USA, Sept 14-15 in Boston

BioData Congress Americas 2016

BioData World Congress USA 2016
September 14-15, 2016

Hyatt Regency, Boston, MA

BioData World Congress USA is the world’s leading event for individuals working with Big Data in precision medicine.

The two day conference will feature case study applications of Big Data and Genomics to drive precision medicine into the clinic through the assembly of the multidisciplinary cohort involved in the delivery of the Precision Medicine

The event will cover a range of different topics including:

  • How to manage data generated in bioinformatics
  • How to utilise NGS to develop more targeted therapeutics
  • How to practically apply genomic data in precision medicine
  • Utilizing the Cloud for collaborative research
  • Developing secure information systems
  • Ethical considerations in the sharing of genomic data
  • How to transition big data into the clinic
  • How to access open source technologies in LS research
  • How to apply big data analytics to mine information

Click here for more information, including how to register.

Call for Proposals: Innovations in Life Sciences and Stakeholder and Agency Responses

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder and agency responses for presentation at our Tenth Annual Health Law Symposium. The Symposium will take place at Loyola University Chicago School of Law on Friday, October 28, 2016 at 9:30am.

The Symposium will explore recent innovations in life sciences and responses by regulatory agencies including FDA, FTC, and DOJ as well as stakeholder responses and recommended next steps for policy and regulatory reforms.

A range of topics will be considered, including but not limited to gene editing, mobile health,
cybersecurity, personalized/precision medicine, 3-D printing technologies, Cancer Moonshot 2020, biosimilars and interchangeable biologics, and vaccine development and incentives (e.g., Zika).

Submission Information: Those interested in participating, please send a 1000-word abstract to  health-law at luc.edu by May 31, 2016. Authors will be notified of decisions no later than June 15, 2016. If your abstract is selected, a full paper will be due by January 6, 2017.

Covered expenses: Hotel, travel, ground transportation, three provided meals.

Questions: E-mail questions to health-law@luc.edu Continue reading

REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading

Health Care Politics in the US South

by Emma Sandoe

Courtesy of Vanderbilt Center for Medicine, Health, and Society http://www.vanderbilt.edu/mhs/the-politi…

This month I attended the Politics of Health Care in the US South conference held at Vanderbilt. This conference was cosponsored by the Anna Julia Cooper Center at Wake Forest. Instead of a lengthy conference summary, I’ll attempt to capture some of the key lessons I learned to better understand the politics of the South.

What is the South?

There is no other region of the country with such a strong personal identification and complex emotional reaction as the South. Californians don’t identify as “Westerners;” “New Englander” inspires connotations of sleepy scenes of snow and hot chocolate; and while you may get a rare character that strongly identifies as a “Midwesterner,” there is a clear difference in the passion that a Minnesotan speaks of their homeland compared to a Tennessean. But despite the fact that the words “the South” strikes passion in its residents, historical and modern important moments in our nations conversation on race, and a specific cultural identity, there is really no common definition of the geographic South. Modern politics make the inclusion of Maryland and DC counter to our understanding of the deep red political vote. Texas and Florida have their own unique identities and their vast populations often skew any analysis of the region. Each unique issue in the South first requires a definition of what geographic region you are discussing.

Continue reading

The Petrie-Flom Center & Coalition to Transform Advanced Care Launch “The Project on Advanced Care and Health Policy”

The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.

March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.

This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care.  Continue reading

TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.