Petrie-Flom Center Welcomes New Executive Director!

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shachar_peopleWe are thrilled to announce that Carmel Shachar, JD, MPH (HLS ’10, HSPH ’10) will join the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School as our next Executive Director. In this role, Carmel will be responsible for oversight of the Center’s sponsored research portfolio, event programming, fellowships, student engagement, development, and a range of other projects and collaborations.

“We are delighted that Carmel will be joining the Center,” said I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center. “Throughout her career, Carmel has focused on designing, developing, and executing large health law and policy projects. This expertise and leadership will be a strong resource for the Center as it implements the vision for its second decade.”  Continue reading

Call for Abstracts: Wiet Life Sciences Law Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for its inaugural Wiet Life Science Law Scholars Conference on Friday, October 13, 2017.

The conference is designed to provide a new intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship. The phrase “life science law” aims to capture research and disciplines spanning food and drug law, health law, intellectual property (IP), biotechnology, environmental, administrative, antitrust, and other realms that involve the life sciences in some meaningful respect. Our goal is to foster recognition of life science law as a cohesive, dynamic, area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars. Modeled after successful events for law professors and scholars in other areas, participants will be organized in topical panels of three to five authors with approximately 15-20 minutes allotted to each abstract presentation, followed by discussions with scholar attendees. Abstracts from the authors will be distributed one week prior to the conference; authors may also submit draft articles for distribution to conference attendees.

SUBMISSION AND REVIEW TIMELINE: The deadline for 750-1,000 word abstracts, including author contact information is June 15. Submit via email to health-law@luc.edu with subject line Wiet Life Science Law.

Authors will be notified of speaker selections by email on or before July 15.

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JOB OPPORTUNITY: The Petrie-Flom Center is searching for a new Executive Director!

PFC Logo-New-Horizontal_slideExecutive Director

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Harvard Law School, Cambridge, MA

Learn more and apply now online!

Duties & Responsibilities

The Executive Director works in partnership with the Faculty Director on strategic planning and vision for the Center, and oversees the Center’s staff, activities, and collaborations, including sponsored research, fundraising, events and conferences, publications, programs for students, administration, finance, communications, and other programmatic activities.  S/he also engages in independent scholarly activities, including research and writing, lecturing, and occasional teaching, as appropriate.

Essential Functions

The Executive Director works with the Faculty Director and independently to build the Center and advance its public profile and impact among policymakers, academics, practitioners, and students.  Primary responsibilities include:

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LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

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Webinar: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

Monday, December 19, 2016, 12:00 – 1:00pm

WATCH LIVE ONLINE!: http://petrieflom.law.harvard.edu/events/details/president-elect-trumps-health-policy-agenda

Submit your questions to the panelists via Twitter @PetrieFlom.

Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will address the future of the Affordable Care Act under a “repeal and replace” strategy, alternative approaches to insurance coverage and access to care, the problem of high drug prices, innovation policy, support for scientific research, and other topics. The panel will discuss opportunities and obstacles relevant to President-elect Trump’s proposals, as well as hopes and concerns for health policy over the next four years. Webinar participants will have the opportunity to submit questions to the panelists for discussion.

Panelists

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • Lanhee J. Chen, David and Diane Steffy Research Fellow, Hoover Institution; Director of Domestic Policy Studies and Lecturer, Public Policy Program; affiliate, Freeman Spogli Institute for International Studies, Stanford University
  • Douglas Holtz-Eakin, President, American Action Forum
  • Moderator:Gregory Curfman, Editor-in-Chief, Harvard Health Publications

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New Hastings Center Special Report – NFL Player Health: The Role of Club Doctors

On November 21, 2016, the Law & Ethics Initiative of the Football Players Health Study at Harvard University, led by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, published a Special Report in the Hastings Center Report, entitled NFL Player Health: The Role of Club Doctors. The Special Report consists of multiple parts.

First, the Special Report includes the Law & Ethics Initiative’s main article, entitled A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player TrustThis article focuses on the principal recommendation of our recent report, Protecting and Promoting the Health of NFL Players: Legal and Ethical Analysis and Recommendations, for addressing the conflicts of interest inherent in the current structure of NFL player healthcare, in which club medical staff provide services to both the club and players.

The article proposes to “resolve the problem of dual loyalty by largely severing the club doctor’s ties with the club and refashioning that role into one of singular loyalty to the player-patient.” Specifically, club physicians would be replaced by two sets of medical professionals: the players’ medical staff, with exclusive loyalty to the player, and the club evaluation doctor, with exclusive loyalty to the club. 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

The Once and Future Regulation of Biotechnology

By Seán Finan

whitehouse_slideOn 16th September, 2016, the White House released two documents jointly authored by the FDA, the EPA and the USDA. Together, the “Update to the Coordinated Framework for the Regulation of Biotechnology” (the “Update”) and the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the “Strategy”) will form the basis for the federal government’s regulatory policy for biotech for the foreseeable future. So, where did these documents come from? What do they contain?

Background

Last year, the federal government asked the FDA, the EPA and the USDA to

  1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
  2. Develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
  3. Commission an expert analysis of the future landscape of biotechnology products

(Source)

14 months, three public meetings and 900 responses to a Request for Information later, the two documents were released. The Update sets out to respond to the first of the above prompts and the Strategy aims to respond to the second. An answer to the third is still in the pipeline.

Aims

The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):

The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers

Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim

  • to help the public understand how the safety of biotechnology products is evaluated and
  • to help businesses navigate the current regulatory structure.

Continue reading

DUE TOMORROW, 9/9! Call for Harvard Submissions to Journal of Law & the Biosciences

image001The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and the Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students and postdoctoral fellows from any school to contribute papers to be published in JLB’s Notes & Developments section in early 2017. We will consider student papers that will be generated specifically for JLB, as well as papers that have been (or will be) initially written as student notes or course papers and edited for this particular purpose. JLB Notes & Developments are limited to 5000 words, including footnotes and references, and should be on a topic of relevance to law and the biosciences, in particular a topic of relatively recent concern, controversy, or change. They should focus on describing the issue at hand, explaining why it is relevant to scholars, and providing analysis and questions for further consideration. For recent examples of submissions by Harvard students, check out the April 2016 issue of the JLB. 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 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.

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.

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

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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

Seeking Research on How Policies, Laws, and Regulations Can Help Build a Culture of Health

With the focus to generate actionable evidence to guide legislators and other policymakers, public agencies, educators, advocates, community groups, and individuals, the RWJF Policies for Action Program has launched its first Call for Proposals (CFP).

Research should inform the significant gaps in our knowledge regarding how policies can serve as levers to improve population health, well-being, and equity. Approximately $1.5 million will be awarded through this CFP.

An informational webinar will take place on Tuesday, February 16 from 1-2p.m. ET, where Director of P4A, Scott Burris, JD, will answer any questions you may have.

Webinar

 

 

10/14: Webcast on the NIH’s Efforts to Support Translational Science

This month’s Regulatory Science Series presentation features Dr. Keith Joiner, MD, MPH, the Director of the Center for Management Innovations in Health Care at the Eller College of Management, and former Dean of the University of Arizona College of Medicine. He will present on NIH Efforts to Support Translational Science and discuss the importance of government funding policy to the regulatory science endeavor.

This event will stream live at 12:00 PM MT on Wednesday, October 14, 2015, at:  https://streaming.biocom.arizona.edu/event/index.cfm?id=26072.

The University of Arizona Regulatory Science Program is a partnership with the James E. Rogers College of Law and University of Arizona Health Sciences.

Hiring Announcement: Loyola University Chicago Beazley Institute for Health Law

Loyola University Chicago School of Law is pleased to invite applications for a full-time tenure-track position, at the rank of Assistant/Associate Professor with expertise in health law, beginning in fall 2016. We seek a scholar-teacher whose substantive interests are in the areas of administrative law, healthcare regulation, corporate health law and/or food and drug/pharmaceutical law. The full job announcement can be found at www.careers.luc.edu.

Continue reading

Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“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). Continue reading