Introducing New Blogger Mason Marks 

Mason Marks is joining Bill of Health as a regular contributor.

Mason is a Visiting Fellow at Yale Law School’s Information Society Project. His research focuses on the application of artificial intelligence to clinical decision making in healthcare. He is particularly interested in the regulation of machine learning and obstacles to its adoption by the medical community. His secondary interests include data privacy and the regulation of emerging technologies such as 3D-bioprinting, surgical robotics, and genome editing.

Mason received his J.D. from Vanderbilt Law School. He is a member of the California Bar and practices intellectual property law in the San Francisco Bay Area. He has represented clients in the biotechnology, pharmaceutical, and medical device industries. Prior to law school, he received his M.D. from Tufts University and his B.A. in biology from Amherst College.

Representative Publications:  Continue reading

Call For Abstracts, Due 10/15! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

Introducing New Blogger Leslie Griffin

We are pleased to introduce our newest contributor, Leslie Griffin, to Bill of Health.

Dr. Leslie C. Griffin is the William S. Boyd Professor of Law at the University of Nevada, Las Vegas, William S. Boyd School of Law. She holds a Ph.D. in Religious Studies from Yale University and a J.D. from Stanford Law School. She is author of the Foundation Press casebook, Practicing Bioethics Law (2015), which was co-authored with Joan H. Krause, Dan K. Moore Distinguished Professor of Law at the University of North Carolina School of Law, and Bill of Health blogger. Before becoming a law professor, Professor Griffin clerked for the Honorable Mary M. Schroeder of the U.S. Ninth Circuit Court of Appeals and was an assistant counsel in the Department of Justice’s Office of Professional Responsibility, which investigates professional misconduct by federal prosecutors. Before joining the UNLV faculty, Professor Griffin held the Larry & Joanne Doherty Chair in Legal Ethics at the University of Houston Law Center and was a tenured member of the faculty at the Santa Clara University School of Law.

Representative Publications Continue reading

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

Continue reading

Introducing New Blogger Anthony W. Orlando

Anthony W. Orlando is joining Bill of Health as a regular contributor.

Anthony is an Assistant Lecturer in the Sol Price School of Public Policy at the University of Southern California, where he is completing his PhD in Public Policy and Management. He also contributes to the Huffington Post. He hosts the podcast “Our American Discourse,” sponsored by the USC Bedrosian Center. He received his bachelor’s degree in economics from The Wharton School of the University of Pennsylvania, as well as a master’s in economic history from the London School of Economics and Political Science. He is a member of the American Society of Law, Medicine & Ethics.

Representative publications:

Please join us in welcoming Anthony!

What’s Next for the ACA?: A Lecture by Larry Levitt

What’s Next for the ACA?: A Lecture by Larry Levitt
October 3, 2017 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.

Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.

This event is free and open to the public.

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

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

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

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

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

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

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

Book Launch: Law, Religion, and Health in the United States

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

Continue reading

Call For Abstracts! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School 

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

Continue reading

What’s Next for the ACA?: A Lecture by Larry Levitt

What’s Next for the ACA?: A Lecture by Larry Levitt
October 3, 2017 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.

Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.

This event is free and open to the public.

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

Five Years of Bill of Health: Student Fellow Contributions

This month we’re celebrating five years of Bill of Health, the success of which would not have been possible without the great contributions of our Student Fellows. Each year, as part of their Fellowship, these diverse students post regularly on issues related to their areas of research and interest, and several have stayed on as regular contributors after the completion of their Fellowships. We’re excited about this year’s contributions, and thank all of our former Fellows for their excellent work!

Below is a list of the top three Student Fellow posts by year, measured by total unique page views (note: one per author selected if multiple posts; older posts have more weight based on more time online): Continue reading

Book Launch: Law, Religion, and Health in the United States

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

Continue reading

Introducing New Blogger James Love

James Love is joining Bill of Health as a regular contributor.
James Love is the Director of Knowledge Ecology International, where his research focuses on the production, management and access to knowledge resources, and aspects of competition policy. This includes work on the financing of R&D, intellectual property rights, prices for and access to new drugs, vaccines and other medical technologies, as well as related topics for other knowledge goods, including software, other copyrighted works, and data.  He previously worked for the Center for Study of Responsive Law, and before that, as Senior Economist for the Frank Russell Company. He has a MPA from Harvard University’s Kennedy School of Government and an MA from Princeton’s Woodrow Wilson School of Public and International Affairs. James will be blogging about  the policies to grant or revoke exclusive rights to make and sell medical products, as well as drug development costs.

Recent Publications:

Welcome, James!

2017 Petrie-Flom Center Annual Open House

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

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

This event is free and open to the public.

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

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

The Neurolaw Revolution: A lecture by Francis X. Shen

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

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

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

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

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

Federal “Right to Try” Legislation – Perpetuating a Misguided Skepticism Towards the FDA

Cross-posted from the CRITical Thinking blog.

By Jeanie Kim

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

As of September 2017, 37 states have enacted RTT laws. Earlier this year, the Senate and the House introduced federal RTT bills, and on August 3, 2017, the Senate unanimously passed an amended RTT bill without an opportunity for debate. There is pressure on the House to follow suit, but it is unclear whether the House will consider the originally introduced RTT bill (“RTT 1.0”) or the Senate’s amended version (“RTT 2.0”), or even take up the legislation at all.

Despite the recent legislative backing, RTT is not a new concept. It is a variation on an age-old skepticism towards the FDA that has been around as long as the agency’s inception. At the core of RTT is the previously rejected, yet persistent argument that the FDA’s approval standards for safety and efficacy should not matter for terminally ill patients who have nothing to lose [1]. Continue reading

Introducing the 2017-2018 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2017-2018 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.

Clíodhna Ní Chéileachair is an LL.M student from Ireland at Harvard Law School, and holds a BCL degree in Law and Philosophy from University College Dublin. Prior to her masters, she worked as a teaching assistant in criminal law, company law and the philosophy of law in University College Dublin and as a paralegal in a corporate firm, with a focus on healthcare litigation and employment law. Her primary research interests are in the intersection of feminist legal theory and health law, ethics and the philosophy of law, particularly in relation to questions of consent and objectivity. For her Fellowship project, Clíodhna will study the manner in which health law and policy intersects with issues of personhood and autonomy in the context of pregnancy.

Aobo Dong is an M.T.S. candidate in Religion, Politics, and Ethics at the Harvard Divinity School. He graduated from Wesleyan University, where he majored in Social Studies and examined the alliance between American evangelicals and the GOP in his honors thesis. At Harvard, his research interests have shifted toward reconciling potential conflicts between religion and the modern human rights discourse, particularly in terms of sexuality, health, and other social-economic rights. He is also a junior fellow at the Science, Religion & Culture (SRC) program. For his Fellowship project, Aobo will investigate the legal and ethical challenges surrounding the fast-expanding healthcare cost-sharing ministries (HCSMs) that provide members with an alternative to traditional insurance models.

Gali Katznelson is a M.Be. candidate at the Center for Bioethics at Harvard Medical School. She completed a bachelor’s degree in Arts & Science at McMaster University in Ontario, Canada. Her research interests include the ethics of emerging healthcare technologies. For her Fellowship project, she will focus on physician perceptions of the use and regulations of mobile health applications.

Yusuf Lenfest is an M.T.S. candidate in Islamic Studies at the Harvard Divinity School. He pursued undergraduate and graduate education at the University of Vermont (BA) and the London School of Economics (MSc) in the fields of literature, philosophy, and comparative politics. He is trained as a jurist in the Maliki school of law, in which he is qualified to issue fatwa, and he also completed advanced training in the fields of legal theory and theology under the tutelage of renowned Mauritanian scholar Shaykh Abdallah Bin Bayyah. For his Fellowship project, Yusuf will examine bioethical issues in contemporary Islamic legal and religious thought.

Thank You for Five Great Years!

Five years ago today, the first post went up on Bill of Health. Since then, the blog has received over 980,000 unique page views from 220 countries, helping to further the discussion of issues in health law policy, biotechnology, and bioethics and to publicize opportunities in the field. Over 3,100 posts have covered everything from ethical issues with bioengineered interspecies organ transplants to potential medical malpractice concerns with artificial intelligence to fetal personhood and the Constitution to analysis of surrogacy arrangements gone awry to food safety issues in China.

As the field has changed over the past five years, so too has the blog. We’ve developed collaborations with other organizations and blogs, hosted a series of blog symposia, blogged “live” from conferences, and expanded the participation of our center’s diverse Fellows. In celebration of our anniversary, this month we will feature posts that highlight these past contributions and new posts that explore the development of issues in health law policy, biotechnology, and bioethics over the past five years.

Our most popular posts, based on total unique page views, reflect the diversity of topics Bill of Health covers: Continue reading

2017 Petrie-Flom Center Annual Open House

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

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

This event is free and open to the public.

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

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