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.

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

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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

Introducing the 2015-2016 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2015-2016 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research. Continue reading

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, 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.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!

Thank you for 3 great years!

Three years ago today, we launched the Bill of Health blog to create a one-stop-shop for readers interested in news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. We have been thrilled at the blog’s success and reach so far.

A few quick stats:

  • We have 90 contributors from 49 institutions around the globe.
  • More than 350,000 unique visitors from more than 200 countries have visited the blog since it was first launched.
  • The blog gets more than 17,000 page views per month.
  • We’ve clocked in over 2,000 blog posts covering a wide range of topics:
    • Health insurance, health care finance, health care reform
    • Reproductive health and rights
    • Pharmaceutical regulation
    • Food safety and regulation
    • Human subjects research
    • Personhood and animal rights
    • General health law, policy, and bioethics

As a sample, here are the top five most viewed posts from each academic year:

2012 – 2013

  1. The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills, by Jonathan Darrow
  2. Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?, by Jonathan Darrow
  3. Liability for Failure to Vaccinate, by Arthur Caplan
  4. Discrimination in the Doctor-Patient Relationship, by Holly F. Lynch
  5. At $28,000 a Dose, How Effective Is Acthar?, by Jonathan Darrow

2013 – 2014

  1. Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON, by Jonathan Darrow
  2. Taking China’s Food Safety Problem Seriously (I), by Ching-Fu Lin
  3. Medical Marijuana Delivery May Not Be As “Eazy” As It Seems, by Arielle Lusardi
  4. Taking China’s Food Safety Problem Seriously (II), by Ching-Fu Lin
  5. Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3, by Daniel Barth-Jones

2014 – 2015

  1. Highlights from the 21st Century Cures Act, by Rachel Sachs
  2. Savior Siblings in the United States, by Zachary Shapiro
  3. New browser app shines light on conflicts of interest, by Christine Baugh
  4. A New Cholesterol-Lowering Drug at What Price?, by Kate Greenwood
  5. Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law by Amanda C. Pustilnik

Thanks to our many contributors – and to our readers!  We look forward to many more years of growth.  And always, if you have any comments or suggestions, make sure to send them our way: petrie-flom@law.harvard.edu.  Happy reading!

Glenn and Holly 
Bill of Health Co-Editors

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Call for Abstracts: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics & Tobacco Products

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

Webinar, 5/6: Policy Surveillance and Public Health

May 6, 2015 at 12 p.m. ET

Policy surveillance is the ongoing, systematic collection, analysis, and dissemination of data about laws and policies. There is a long tradition of conducting “50 state surveys” to identify laws of public health significance, but the methods for creating these surveys are largely unscientific. Unlike this traditional legal research, policy surveillance uses systematic quantitative and qualitative coding to create scientific datasets and track policies over time. Throughout the past year the Robert Wood Johnson Foundation’s Public Health Law Research program, the Network for Public Health Law, ChangeLab Solutions and the CDC Public Health Law Program have been exploring policy surveillance through a Delphi process and within their programs. This webinar will present the findings from that Delphi study and will explore the role of policy surveillance in understanding the impact of law on public health.

Presenters include:

  • Jennifer Ibrahim, PhD, MPH, Associate Director, Public Health Law Research program, Associate Professor, College of Public Health at Temple University
  • David Presley, JD, Policy Surveillance Manager, Public Health Law Research program
  • Matthew Penn, JD, MLIS, Director, Centers for Disease Control and Prevention, Public Health Law Program
  • Donna Levin, JD, Director, Network for Public Health Law (Moderator)

Register here.

Post-Trial Access and Responsibilities (and Upcoming Conference, Sept. 18 at HLS)

By Zachary Shapiro

Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is widely available or approved for the market (or maybe longer/in other circumstances). At issue is the question of the commitment a clinical trial sponsor owes the participants of their trial (and maybe others) in the period after a clinical trial phase, but before market approval of the tested pharmaceutical (or maybe longer).

While the provision of Post-Trial Access may seem to be an ethical “no-brainer,” there are numerous variables that make the decision of whether to provide PTA difficult. One major question is whether all arms of the trial deserve access to the therapy, even those who were on placebo or in the control arm. If the therapy tested shows less efficacy than a more or less expensive treatment modality, is there a responsibility to provide the more effective treatment, regardless of the cost? What if said therapy is far beyond the standard of care for the condition in the particular country where the trial took place? Furthermore, how long do PTA obligations extend? While the simple answer is that they end after market approval, the truth is that many drugs have long approval processes, with complicating factors that can result in significant delays. This is an even more difficult question if the trial is a multi-regional study, and takes place in a country where the sponsor does not intend to market the product.

The question of how to provide PTA also poses logistical issues, as many sponsor sites close after a clinical trial is finished. This can make provision of post-trial access extremely expensive, and perhaps unduly burdensome, especially if the trial is sponsored by a biotech start-up without the deep pockets of a large pharmaceutical company. These costs can skyrocket depending on whether we believe the sponsor should be responsible for costs that might result from improper use of the therapy, or failure of the participants to comply with proper treatment. Continue reading

Introducing the 2014-2015 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2014-2015 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.

Continue reading

Open Clinical Ethics Positions at Boston Children’s Hospital

Interested candidates should apply at www.childrenshospital.jobs.

Temporary Clinical Ethicist

The Clinical Ethicist provides formal and informal ethics consultations and collaborates with clinical teams, patients and families, managers, and consultants to address ethical issues in pediatric health care and research. Documents ethics activities. May participate in clinical ethics rounds and other educational activities.

Requires working knowledge of theories, principles and concepts typically acquired through completion of a graduate degree in ethics, bioethics, or moral philosophy; a working knowledge of health care and hospitals or clinical degree in a health professional field; and extensive experience in clinical bioethics, preferably in hospital or health delivery systems. Work requires excellent interpersonal, organizational, oral and written communication skills in order to mediate moral disagreements or concerns and develop consensus, compromises, or other ethically acceptable resolutions. Work requires sensitivity in speaking with parents, patients, staff and others in stressful circumstances, in discussing ethical decisions regarding life support, dying and death, disclosure of bad news, participation in research, organ donation and transplantation, and other potential conflicts of interest and values. Work requires demonstrated ability in multidisciplinary collaboration and the ability to initiate, prioritize, and manage multiple projects, working across multiple departmental lines of authority and accountability and under pressure to meet deadlines.

Clinical Ethicist

Provides formal and informal ethics consultations.  Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.

Work requires at least 5 years clinical inpatient experience in a staff physician or nursing role with substantial prior ethics education and experience derived from completion of an ethics fellowship or other advanced ethics training and/or significant ethics consultation experience.  Preference for a clinical degree in a health professional field and graduate level preparation in this discipline, clinical ethics fellowship completion, graduate degree in bioethics or related field, a strong understanding of acute care pediatric health care, and five or more years of experience in clinical bioethics, preferably in a pediatric hospital or health delivery system. Significant focus on inpatient pediatric ethics consultations with active collaboration with nursing, social work, medical staff, and other internal and external individuals and groups.

Continue reading

See and Share Job and Fellowship Opportunities on the Petrie-Flom Website

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Looking for new opportunities in the fields of health law, policy, and bioethics? Look no further!

This spring, we’ve added a new opportunities section to the resources on the new Petrie-Flom website. This page features opportunities in health law and bioethics including jobs, fellowships, graduate programs, seminars, calls for abstracts and submissions—and more! These opportunities are updated in real time, full posts remain active on the website until their deadline passes, and past posts are visible in our opportunities archive.

If you have opportunities that you would like to share with the Petrie-Flom community via our website and/or our biweekly e-newsletter, please contact us at petrie-flom@law.harvard.edu.

New Joint Project on Law and Applied Neuroscience

The MGH Center for Law, Brain and Behavior and Harvard Law School’s Petrie-Flom Center announce joint “Project on Law and Applied Neuroscience” for 2014-2016

The MGH Center for Law, Brain and Behavior and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will collaborate on a joint venture – the Project on Law and Applied Neuroscience – beginning in Fall 2014. The collaboration will include a Senior Fellow in residence, public symposia, and an HLS Law and Neuroscience Seminar.

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American, Georgetown, and Hamline Law Offer Summer 2014 Health Law Courses

American University Washington College of Law’s seventh annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and online courses focusing on: (1) pharmaceutical law, (2) bioethics, (3) health care fraud and compliance, and (4) the economics of health care reform.

The O’Neill Institute for National and Global Health Law at Georgetown University is pleased to present two programs this summer: (1) Emerging Issues in Food and Drug Law and (2) U.S. Health Reform – The Affordable Care Act.  Now in its third year, the Summer Programs will convene leading practitioners, policymakers, advocates and academics in global food and drug law and US health reform for a series of interactive lectures, panel discussions, and case studies.  Held during consecutive weeks, July 14-18 (Emerging Issues in Food and Drug Law) and July 21-25 (US Health Reform – The Affordable Care Act), interested participants may attend one or both programs.  Additional details, including schedule, speakers, online application, and program fees may be found here.  Questions may be directed to oneillsummer@law.georgetown.edu.

The Hamline University School of Law Health Law Institute is pleased to offer a variety of condensed health law courses taught by academic and industry experts in Saint Paul, MN. Courses include: (1) Health Care Compliance Institute, (2) Biotechnology Policy, (3) Elder Law, and (4) Health Care Fraud and Abuse. Courses will run from May 27th through June 28th. Additional information, including the application and course descriptions can be found here.

 

Ten Faculty Fellowships Awarded to Promote Public Health Law Education

Official Press Release:

Atlanta – Georgia State University College of Law and its Center for Law Health & Society have selected 10 faculty fellows to participate in the Future of Public Health Law Education: Faculty Fellowship Program. The program is funded by the Robert Wood Johnson Foundation to foster innovations and build a learning community among those who teach public health law at professional and graduate schools. For more information, visit law.gsu.edu/phlfellowship.

The fellows, chosen from across the country, will develop interdisciplinary courses and programs in public health law at their respective universities during the fellowship year. Their projects will strengthen interdisciplinary education in public health law and promote collaborations with public health agencies and organizations in the fellows’ communities.

The fellows are:

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Max Mehlman: 2014 McDonald Merrill Ketcham Awardee for Excellence in Law & Medicine

By Nicolas Terry Cross-posted from HealthLawProf Blog

The Hall Center for Law and Health at Indiana University McKinney School of Law is proud to welcome Professor Maxwell Mehlman to receive the McDonald Merrill Ketcham Award for Excellence in Law & Medicine for 2014. For more details please see here.

Professor Mehlman serves as Distinguished University Professor, Petersilge Prof. of Law and Director of the Law-Medicine Center, Case Western Reserve School of Law, and Professor of Biomedical Ethics, Case Western Reserve School of Medicine. His lecture is entitled “Are Physicians Fiduciaries for Their Patients?” Professor Mehlman will then join a panel discussion on the topic. The panelists are Mary Ott, M.D., M.A., Associate Professor of Pediatrics, Indiana University School of Medicine, Joshua Perry, J.D., M.T.S., Assistant Professor of Business Law and Ethics and a Life Sciences Research Fellow, Indiana University Kelley School of Business (Bloomington) and Mark Rothstein, J.D., Herbert F. Boehl Chair of Law and Medicine, University of Louisville Louis D. Brandeis School of Law, and Director of the Institute for Bioethics, Health Policy, and Law, University of Louisville School of Medicine.