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

DUE AUGUST 5: Call for Apps – Petrie-Flom Center Harvard Grad Student Fellowship

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS 

The 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.

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 at Harvard to wait until after their first year to apply.

Requirements. All student fellows will have the following responsibilities: Continue reading

New Resource: BPCIA Legislative History Documents

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products.  Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole.  This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA.  In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court.  Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant.  At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act.  The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

Introducing our 2016 Summer Student Bloggers

The Petrie-Flom Center is pleased to welcome Kelly Dhru and Shailin Thomas to Bill of Health as our 2016 Summer Student Bloggers!

Kelly Dhru - photo1 (2)Kelly Amal Dhru is an incoming LLM student at the Harvard Law School, and a 2016-17 Fulbright-Nehru Master’s Fellow in Public Health Law and Bioethics from India. Previously, Kelly has completed her BCL (Distinction) and MPhil in Law from University College, University of Oxford, where thesis focused on the gap between rights and duties in the context of laws preventing cruelty to animals. Kelly holds a law degree from Gujarat National Law University, and has been the Research Director at Research Foundation for Governance in India, where she has been involved in drafting laws relating to public health, bioethics and human rights. Kelly has been a research assistant for Public Health Law at King’s College London, taught the Law of Tort, Jurisprudence and Bioethics at the University of Oxford, and Ethics and Philosophy at Ahmedabad University in India. She is a co-founder and storywriter for Lawtoons: a comic series on laws and rights, and been involved spreading awareness about public health and human rights through the use of street theatre.

Thomas Shailin PhotoShailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine.  He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology underlying social phenomena.  His interests lie at the intersection of clinical medicine and the legal forces that shape it.  Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society.  He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology.  A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut.

Harvard Grad Students Apply Now! Petrie-Flom Center Student Fellowship, 2016-2017

PFC_Logo_300x300The Center and Student Fellowship: The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 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 student research in these areas. More information on our current fellows and their work, is available on the Center’s website.

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 at Harvard to wait until after their first year to apply.

Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).

Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 5, 2016. Notifications of awards will be made by August 19, 2016.

Apply now! View the full requirements and application instructions on our website: http://petrieflom.law.harvard.edu/fellows/student-application.

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

Making Big Data Inclusive

Guest post by Sarah Elizabeth Malanga, Fellow, Regulatory Science Program, James E. Rogers College of Law, University of Arizona, based on her presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held on May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

Big Data, which is derived from a multitude of sources including, social media, “wearables,” electronic health records, and health insurances claims, is increasingly being used in health care and it can potentially improve the way medical professionals diagnose and treat illnesses.

But what happens when Big Data only captures a snapshot of the population, rather than an overall picture of the population as a whole? The sources that generate Big Data – the Internet and credit card use, electronic health records, health insurance claims – are not utilized by everyone. Certain demographics may be missing from or underrepresented in Big Data because they do not own smartphones, have access to the Internet, or visit doctors on a regular basis because they lack health insurance. These sectors of the population disproportionately include low-income individuals, minority groups such as blacks and Hispanics, and the elderly. 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

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

Monday, 4/18, HLS Health Law Workshop with Robert Cook-Deegan

April 18, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

The materials for the presentation, “Mining the Genomic Data Mountain: Legal and Policy Challenges,” can be downloaded here.

Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology (Trinity College of Arts & Sciences). He was the founding director for Genome Ethics, Law & Policy in Duke’s Institute for Genome Sciences & Policy from July 2002 through December 2012.  He is the author of The Gene Wars: Science, Politics, and the Human Genome and an author on over 250 articles.

Dr. Cook-Deegan’s areas of expertise include genomics and intellectual property, history of genomics, global health, science and health policy, and health research policy. His current research focuses on policy implications of genomics, bioethics, intellectual property, and innovation.

Monday, 4/11, HLS Health Law Workshop with Nathan Cortez

HLS Health Law Workshop: Nathan Cortez

April 11, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Presentation: “Regulation by Database”

Nathan Cortez is Associate Dean for Research and Associate Professor in Dedman School of Law at Southern Methodist University. He teaches and writes in the areas of health law, administrative law, and FDA law.  His research focuses on emerging markets in health care and biotechnology. He has become one of the world’s leading legal scholars on medical tourism, patient mobility, and cross-border health insurance.

His research also addresses mobile health technologies, how to regulate innovations that disrupt static regulatory regimes, the First Amendment restraints on FDA regulation (including FDA’s graphic tobacco warnings), immigration federalism, and alternative modes of regulation.

Academic Immersion

Editor’s Note: The Petrie-Flom Center is now accepting applications for Student Fellowships for the 2016-2017. See our website for more information about applying! 

Last week, the New England Journal of Medicine published a Perspectives article describing the “Immersion Day” it holds for its board members. On the Immersion Day, participants don scrubs and shadow front line employees across various parts of the hospital – this might include attending ICU rounds or observing a surgery. The day gives board members the opportunity to meet and engage with staff in a meaningful way as they go about their jobs, painting a vivid picture of the issues and concerns that arise on paper in the board room. In its third year, the program is a resounding success, garnering rave reviews from the trustees. In fact, the hospital has now created an Immersion Day for state policymakers.

Having worked as a clinician before moving into policy and research, this piece resonated deeply with me. I have found my clinical experience to be essential and formative for how I view policy questions. In addition, as I approach the end of my year as a student fellow, I realized that this piece and the concept of immersion describes my experience with the Petrie-Flom Center. Continue reading

Monday, 4/4, HLS Health Law Workshop with Nicolas Terry

HLS Health Law Workshop: Nicolas Terry

April 4, 2016 5:00 – 7:00 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Presentation: “Regulatory Disruption and Arbitrage in Healthcare Data Protection”

Nicolas P. Terry is the Hall Render Professor of Law at the Indiana University Robert H. McKinney School of Law. He serves as Executive Director of the Hall Center for Law and Health. Professor Terry teaches Torts, Products Liability, Health Information Technology, Law & Science, and Health Care Quality.

Educated at Kingston University and the University of Cambridge, Professor Terry began his academic career as a member of the law faculty of the University of Exeter in England. He has served as a Senior Fellow at Melbourne Law School and held visiting faculty positions at the law schools of Santa Clara University, the University of Missouri-Columbia, Washington University, and the University of Iowa. From 2000-08, Professor Terry served as co-director of Saint Louis University’s Center for Health Law Studies. From 2008-10, Terry served as the School of Law’s Senior Associate Dean.

Professor Terry’s research interests lie primarily at the intersection of medicine, law, and information technology. He is a permanent blogger at the HealthLawProf Blog and at Harvard Law School’s Bill of Health.  Professor Terry is also is the co-presenter of the “The Week in Health Law” podcast.

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.

PANEL (4/5): The National Security Implications of the Genetics Revolution

 

Technology Concept

The National Security Implications of the Genetics Revolution
April 5, 2016 12:00 PM
Pound Hall, Room 101
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

 

Panelists:

  • Jamie Metzl, JD ’97, Senior Fellow for Technology and National Security of the Atlantic Council. He has served on the U.S. National Security Council, State Department, and Senate Foreign Relations Committee, as Executive Vice President of the Asia Society and with the United Nations in Cambodia. A globally syndicated columnist and regular guest on national and international media, he is the author of a history of the Cambodian genocide and the novels The Depths of the Sea and Genesis Code.

Topic: The National Security Implications of the Genetics Revolution

  • George J. Annas, JD, MPH, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

Topic: Post-9/11 Uses of Public Health and Medicine by National Security Agencies 

  • Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor of Ethics, Perelman School of Medicine, University of Pennsylvania

Topic: National Security and Biology

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

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Harvard National Security & Law Association, the Harvard National Security Journal, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

The EEOC’s Role In Reshaping Wellness Programs

This new post by Kristin Madison appears on the Health Affairs Blog concludes the blog series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. In April 2015, the Equal Employment Opportunity Commission took a significant step toward resolving this uncertainty by formally proposing a ruleclarifying the applicability Americans with Disabilities Act of 1990 (ADA) to wellness programs.

In doing so, it staked out middle ground between an approach that would have sharply limited the use of incentives in wellness programs, and a more permissive approach consistent with regulations already in place under the Affordable Care Act (ACA). The proposed rule has the potential to shape, or reshape, future wellness programs. The extent to which it will do so, however, remains uncertain. […]

Read the full post here.

One Patent Law, Two Economic Sectors: Is The One-Size-Fits-All Patent Law Still Workable?

This new post by Claire Laporte appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Ever since the first patent was issued in 1790, the United States has had a single patent law to protect inventions in all fields. Over the past three decades, that law has been strained to the breaking point in covering both the life sciences and other technologies.

On the life sciences side, patents protect platform technologies as well as specific products and are important at every stage of a product’s life cycle. Many scientific breakthroughs arise from federally funded research in universities and other institutions. Under the Bayh-Dole Act, these institutions license the resulting patents to companies, often start-ups, which develop the technology until it is ready to be marketed.

During the many years of the development process, companies need to attract investment, and investors often assess the merits of the patent portfolio as an indicator of the ultimate strength of the company. Once a product is released to the market, patents still matter; each day of patent protection for a blockbuster drug is worth millions. Patent litigation in the life sciences is typically between competitors and reflects an effort by one of those competitors to maintain its exclusivity. […]

Read the full post here.