REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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Reflecting on Dementia and Democracy: America’s Aging Judges and Politicians

By Gali Katznelson

This month, the Petrie-Flom Center collaborated with the Center for Law, Brain & Behavior  to host a panel entitled Dementia and Democracy: America’s Aging Judges and Politicians.” The panelists, Bruce Price, MD, Francis X. Shen, JD, PhD, and Rebecca Brendel, JD, MD, elucidated the problems, as well as potential solutions, to the challenges of America’s judiciary and elected politicians getting older. Reconciling dementia with democracy is a pressing matter. As Dr. Price explained, age is the single largest risk factor for dementia, a risk that doubles every five years after the age of 65, and America is a country with five of the nine Supreme Court Justices over the age of 67, a 71-year-old president, a 75-year-old Senate Majority Leader, and a 77-year-old House Minority Leader.

In his talk “Dementia in Judges and Elected Officials: Challenges and Solutions,” Dr. Shen defined the complex problem. While most other jobs are not retaining workers into old age, many judges and elected officials continue to serve well into their 80s. To complicate matters further, without widespread regulations or metrics to identify how dementia impedes one’s work, the media assumes the position of speculating the cognitive statuses and fates of judges and elected officials. Dr. Shen’s key point was, “Surely we can do better than speculation.”

Dr. Shen proposed several solutions to address dementia in elected officials and judges. Currently, we leave the open market and colleagues to regulate individuals, which remains a valid approach as we consider other options. Another default position is to diagnose based on publicly available data, a solution that introduces the specific ethical concerns that Dr. Brendel addressed in her talk (discussed below). There are, however, novel solutions. We could consider requiring cognitive testing and disclosure (which could be overseen by an internal review board), or we could simply impose an age limit for service. For judges, if such an age limit were imposed, we could create a rebuttable presumption in which a judge can continue to serve by completing an evaluation. Alternatively, perhaps judges can be limited to adjudicating specific cases based on their cognitive status.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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TODAY, 11/20 at 5 PM: Health Law Workshop with Thaddeus Pope

November 20, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

“From Informed Consent to Shared Decision Making: How Patient Decision Aids Can Improve Patient Safety and Reduce Medical Liability Risk.”  Download the presentation here.

Thaddeus Mason Pope is Professor of Law and Director of the Health Law Institute at the Mitchell Hamline School of Law. Pope joined Hamline University School of Law in January 2012 after serving as associate professor of law at Widener University School of Law. There, his research focused on medical futility, internal dispute resolution, tort law, public health law, and normative jurisprudence. He authors a blog on medical futility, reporting and discussing legislative, judicial, regulatory, medical, and other developments concerning end-of-life medical treatment.

Pope also taught at Albany Medical College and the University of Memphis. Prior to joining academia, he practiced at Arnold & Porter and clerked on the U.S. Court of Appeals for the Seventh Circuit. Pope earned a JD and PhD in philosophy and bioethics from Georgetown University.

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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TODAY, 11/13 at 5 PM: Health Law Workshop with Allison Hoffman

November 13, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Health Care’s Market Bureaucracy”

To request a copy of the paper in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Allison K. Hoffman joined the faculty of the University of Pennsylvania Law School in fall 2017. Hoffman’s research examines the role of regulation and the welfare state in promoting health, as well as how regulation affects conceptions of risk and responsibility. Her recent work includes “Reimagining the Risk of Long Term Care” in the Yale Journal of Health Policy Law and Ethics—an article that argues for a more capacious vision of how we think about long-term care risk—and the Oxford Handbook of U.S. Health Law (2017), a volume co-edited with I. Glenn Cohen and William M. Sage. She also contributed a chapter to this volume entitled “What Health Reform Reveals about Health Law,” which explores the Affordable Care Act as a window into the idiosyncrasies of U.S. health care law and the values that have shaped this field. Her work and commentary has been featured in top media outlets, including the New York Times, The Huffington Post, the Wall Street Journal, Reuters, Morningstar, CNBC, the New York Daily News, Marketplace by American Public Media, Jotwell, and Penn Law’s Regulatory Review (formerly RegBlog).

Hoffman received her AB summa cum laude from Dartmouth College and her JD from Yale Law School. After graduating from law school, she practiced law at Ropes & Gray LLP, where she focused on health care regulation. Previously, she provided strategic advice to corporations and nonprofit organizations as a consultant at The Boston Consulting Group and The Bridgespan Group. Prior to joining the Penn faculty, Hoffman was a faculty member at UCLA Law School. She was previously an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

TODAY, 11/6 at 5 PM: Health Law Workshop with David Studdert

November 6, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Once Ticketed, Twice Shy? Specific Deterrence from Road Traffic Laws”

David M. Studdert is Professor of Medicine and Professor of Law at Stanford University. He is a leading expert in the fields of health law and empirical legal research. His scholarship explores how the legal system influences the health and well-being of populations. A prolific scholar, he has authored more than 150 articles and book chapters, and his work appears frequently in leading international medical, law, and health policy publications.

Before joining the Stanford faculty, Studdert was on the faculty at the University of Melbourne (2007-13) and the Harvard School of Public Health (2000-06). He has also worked as a policy analyst at the RAND Corporation, a policy advisor to the Minister for Health in Australia, and a practicing attorney.

Studdert has received the Alice S. Hersh New Investigator Award from AcademyHealth, the leading organization for health services and health policy research in the United States. He was awarded a Federation Fellowship (2006) and a Laureate Fellowship (2011) by the Australian Research Council. He holds a law degree from University of Melbourne and a doctoral degree in health policy and public health from the Harvard School of Public Health.

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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TODAY, 10/30 at 5 PM: Health Law Workshop with Aziza Ahmed

October 30, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “‘Dead But Not Disabled’: A Feminist Legal Struggle for Recognition”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Aziza Ahmed is Professor of Law at the Northeastern University School of Law. She is an internationally renowned expert in health law, criminal law and human rights. Her scholarship examines the role of science and activism in shaping global and national law and policy with a focus on criminal laws that impact health. She teaches Property Law, Reproductive and Sexual Health and Rights, and International Health Law: Governance, Development and Rights. Professor Ahmed has been selected as a fellow with the Program in Law and Public Affairs (LAPA) at Princeton University. She will be combining her sabbatical and her fellowship to spend the 2017-2018 academic year developing her work on law, feminism and science into a book with particular emphasis on legal and policy responses to HIV.

Ahmed’s scholarship has appeared in the University of Miami Law ReviewAmerican Journal of Law and MedicineUniversity of Denver Law ReviewHarvard Journal of Law and GenderBoston University Law Review (online), and the American Journal of International Law (online), among other journals.

Prior to joining the School of Law, Ahmed was a research associate at the Harvard School of Public Health Program on International Health and Human Rights. She came to that position after a Women’s Law and Public Policy Fellowship with the International Community of Women Living with HIV/AIDS (ICW). Ahmed has also consulted with various United Nations agencies and international and domestic non-governmental organizations.

Ahmed was a member of the Technical Advisory Group on HIV and the Law convened by the United Nations Development Programme (UNDP) and has been an expert for many institutions, including the American Bar Association and UNDP. In 2016, she was appointed to serve a three-year term on the advisory board of the Northeastern University Humanities Center.

In addition to her BA and JD, Ahmed holds an MS in population and international health from the Harvard School of Public Health.

TODAY, 10/23 at 5 PM: Health Law Workshop with Belinda Bennett

October 23, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Law, Transformative Technologies and the Automation Age: Lessons from the Past for a High-Tech Future” 

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Belinda Bennett is a Visiting Scholar at the Petrie-Flom Center in fall 2017. She is Professor of Health Law and New Technologies in the School of Law at Queensland University of Technology (QUT) in Brisbane, Australia. She leads the Governance and Regulation of Health Care program within the Australian Centre for Health Law Research at QUT. Her current research addresses health law and globalisation, global public health law, and the legal and ethical challenges associated with regulation of new technologies in health care. Her publications include: M Freeman, S Hawkes and B Bennett (eds) Law and Global Health: Current Legal Issues Vol 16 (OUP, 2014); B Bennett, Health Law’s Kaleidoscope: Health Law Rights in a Global Age (Ashgate, 2008); and B Bennett, T Carney and I Karpin (eds) Brave New World of Health(Federation Press, 2008).

TODAY, 10/16 at 5 PM: Health Law Workshop with I. Glenn Cohen

October 16, 2017 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Cops, Docs, and Code: A Dialogue Between Big Data in Health Care and Predictive Policing” by I. Glenn Cohen & Harry S. Graver

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.

I. Glenn Cohen is Professor of Law and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Glenn’s current research projects relate to health information technologies, mobile health, reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, FDA law and to medical tourism – the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end of life decision-making, FDA regulation and commodification.

 

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 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!

Privacy and Confidentiality: Bill of Health at Five Years and Beyond

In honor of the occasion of the Fifth Anniversary of Bill of Health, this post reflects on the past five years of what’s generally known as “privacy” with respect to health information.  The topic is really a giant topic area, covering a vast array of questions about the security and confidentiality of health information, the collection and use of health information for public health and research, commercialization and monetization of information, whether and why we care about health privacy, and much more.  Interestingly, Bill of Health has no categorizations for core concepts in this area:  privacy, confidentiality, security, health data, HIPAA, health information technology—the closest is a symposium on the re-identification of information, held in 2013.  Yet arguably these issues may have a significant impact on patients’ willingness to access care, risks they may face from data theft or misuse, assessment of the quality of care they receive, and the ability of public health to detect emergencies.

Over the past five years, Bill of Health has kept up a steady stream of commentary on privacy and privacy-related topics.  Here, I note just a few of the highlights (with apologies to those I might have missed—there were a lot!) There have been important symposia:  a 2016 set of critical commentaries on the proposed revisions of the Common Rule governing research ethics and a 2013 symposium on re-identification attacks.  There have been reports on the privacy implications of recent or proposed legislation: the 21st Century Cures Act, the 2015 proposal for a Consumer Privacy Bill of Rights, and the proposed Workplace Wellness Bill’s implications for genetic information privacy.  Many comments have addressed big data in health care and the possible implications for privacy.  Other comments have been highly speculative, such as scoping out the territory of what it might mean for Amazon to get into the health care business. There have also been reports of research about privacy attitudes, such as the survey of participants in instruments for sharing genomic data online.  But there have been major gaps, too, such as a dearth of writing about the potential privacy implications of the precision medicine and million lives initiative and only a couple of short pieces about the problem of data security.

Here are a few quick sketches of the major current themes in health privacy and data use, that I hope writers and readers and researchers and most importantly policy makers will continue to monitor over the next five years (spoiler alert: I plan to keep writing about lots of them, and I hope others will too): Continue reading

TODAY, 10/2 at 5 PM: Health Law Workshop with Alicia Ely Yamin

October 2, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Democracy, Health Systems and the Right to Health: Narratives of Charity, Markets and Citizenship”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Alicia Yamin is the Program Director of the Health and Human Rights Initiative. Prior to joining the O’Neill Institute, Alicia was a Lecturer on Law and Global Health at the Harvard TH Chan School of Public Health, and the Director of the JD /MPH Program. Alicia was also the Policy Director at the François-Xavier Bagnoud Center for Health and Human Rights at Harvard, a Global Fellow at the Centre for Law and octal transformation in Norway, and was selected as the 2015-16 Marsha Lilien Gladstein Visiting Professor of Human Rights, University of Connecticut. Trained in both law and public health at Harvard, Yamin’s 20-year career at the intersection of health and human rights has bridged academia and activism.  From 2007 to 2011, Yamin held the prestigious Joseph H. Flom Fellowship on Global Health and Human Rights at Harvard Law School.  Prior to that, she served as Director of Research and Investigations at Physicians for Human Rights, where she oversaw all of the organization’s field investigations, and was on the faculty of the Mailman School of Public Health at Columbia University. Yamin was a member of the Board of Directors of the Center for Economic and Social Rights for 15 years and the Chair from 2009-2014. Continue reading

TODAY, 9/25 at 5 PM: Health Law Workshop with Francis Shen

September 25, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “How Dangerous are Youth Sports for the Brain? A Review of the Evidence”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.  

Francis X. Shen is the third Senior Fellow 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. He is an Associate Professor at the University of Minnesota Law School, where he heads the Shen Neurolaw Lab. He also serves as Executive Director of Education and Outreach for the MacArthur Foundation Research Network on Law and Neuroscience.

Professor Shen completed his BA in economics and English at the University of Chicago in 2000, his JD at Harvard Law School in 2006, and his PhD in government and social policy at Harvard University and the Kennedy School of Government in 2008. During graduate school he was a doctoral fellow in the Harvard University Multidisciplinary Program in Inequality & Social Policy, supported by the National Science Foundation. From 2007-09, he was a teaching fellow, lecturer, and assistant director of undergraduate studies in the Harvard Department of Government and received five Certificates of Distinction for Excellence in Teaching from Harvard’s Derek Bok Center. 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

TODAY, 9/18 at 5 PM: Health Law Workshop with Jody Madeira

September 18, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Terminating the Paper Trail: Evaluating the Efficacy of a Multimedia Informed Consent Application in Reproductive Medicine”

For context, please also read: “Is Informed Consent in Reproductive Medicine in Critical Condition?”

Jody L. Madeira is Professor of Law and Louis F. Niezer Faculty Fellow at the Indiana University Maurer School of Law. Her scholarly interests primarily involve the intersection of law and emotion in criminal and family law. Madeira’s new book, Killing McVeigh: The Death Penalty and the Myth of Closure, applies collective memory to criminal prosecution and sentencing, exploring the ways in which victims’ families and survivors came to comprehend and cope with the Oklahoma City bombing through membership in community groups as well as through attendance and participation in Timothy McVeigh’s prosecution and execution. She is also actively involved in empirical research projects assessing patient decision making and informed consent in assisted reproductive technology (ART).

Additionally, Madeira investigates the effects of legal proceedings, verdicts, and sentences upon victims’ families; the role of empathy in personal injury litigation; and the impact of recent developments in capital victims’ services upon the relationship between victims’ families and the criminal justice system.

Madeira earned her JD magna cum laude from the University of Pennsylvania School of Law, where she was elected to the Order of the Coif and served as Senior Articles Editor for the University of Pennsylvania Journal of Constitutional Law. She clerked for the Hon. Richard D. Cudahy at the U.S. Court of Appeals for the Seventh Circuit. She then came to Harvard as a Climenko Fellow and Lecturer in Law, where she taught legal research and writing as well as a seminar on the cultural life of capital punishment. Madeira also recently served as a Research Associate at the Capital Punishment Research Initiative at the School of Criminal Justice, University at Albany, State University of New York.