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:

Continue reading

NEW EVENT (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

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. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

PANEL (4/3): Opiate Regulation Policies – Balancing Pain and Addiction

Opiate Regulation Policies: Balancing Pain and Addiction 

April 3, 2017 12:00 PM

Austin Hall, West Classroom (111)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA

Description

The current opiate epidemic has spurred long-overdue scrutiny on the pharmaceutical production and distribution of opiate medication, but it also raises questions of public policy and law regarding the regulation of medical access to and use of opiate medications with high potential for addiction. Expert panelists will address the challenges that arise from efforts to balance restrictions on access to opiates to limit addiction while also preserving sufficient access for legitimate medical management of pain.

Panelists

  • Monica Bharel, MD, MPH, Commissioner, Massachusetts Department of Public Health
  • David Borsook, MD, PhD, Associate Professor in Anesthesiology, Harvard Medical School; co-director, Center for Pain and the Brain at Boston Children’s Hospital, Massachusetts General Hospital, and McLean Hospital; and affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital
  • Rita Nieves, Deputy Director, Boston Public Health Commission
  • Moderator: Amanda C. Pustilnik, JDProfessor of Law, University of Maryland Carey School of Law; affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital; and 2014-2015 Senior Fellow in Law and Applied Neuroscience as 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

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

Learn More

Check out the new EdX course “The Opioid Crisis in America,” developed by faculty at Harvard Medical School, to learn more about opioid addiction, evidence-based treatment models, harm reduction approaches that law enforcement and public health officials are using to reduce opioid overdose deaths, and non-opioid alternatives for medical pain management. This online course is free and self-paced; the first session will be available online on March 27, 2017.

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.

THURSDAY, 3/23! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.

Background: Generic Drugs And Biosimilars

Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]

Read the full post here.

TOMORROW: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

NEW EVENT (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

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. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

NEW EVENT (3/23)! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

TODAY, 3/6 at 5 PM! Health Law Workshop with Khiara Bridges

March 6, 2017, 5-7 PM
Hauser Hall, Room 104

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

Presentation

Download the presentation: 

Note from the Presenter:

I am circulating the introductory chapter from my first ethnography, Reproducing Race: An Ethnography of Pregnancy as a Site of Racialization, and a book proposal for my as yet untitled second ethnography.

My first book grew out of eighteen months of ethnographic fieldwork research that I conducted in the obstetrics clinic of a public hospital in New York City. I found myself in the clinic because I was interested in studying race as a process: I wanted to explore how ideas about race are made material on the bodies of poor women during the event of pregnancy. Moreover, I was curious about the role of the law in this process of race-making.

What I did not realize back when I was writing Reproducing Race was that the book would be a prelude to my second ethnography—a book about which I am now beginning to think. This ethnography will extend the analysis began in Reproducing Race to affluent women of color. Reproducing Race revealed that poor, pregnant women of color are treated in ways that are significantly different from the ways in which wealthier pregnant women are treated. But, how much of that different treatment is an effect of race? How much of it is an effect of class? By training its focus on women of color with class privilege, my second ethnography will try to figure it all out. Thus, the central preoccupation that motivates the study is the complex relationship between race and class. How does class privilege alter the experience of race? How does one’s status as a racial minority alter the experience of class privilege?

The second ethnography is very much in its earlier stages. So, any and all feedback on this project is welcome.

About the Presenter

Continue reading

March 10: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

Should Government Officials Be Held Responsible For Failing To Protect Health?

This new post by Wendy Parmet appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

In May 2016, President Barack Obama observed that Flint, Michigan’s water crisis arose from a “culture of neglect” and the belief “that less government is the highest good no matter what.” The crisis, which developed after the city’s unelected emergency manager switched the water supply from the Detroit Water System to the highly corrosive Flint River, caused dangerously high blood lead levels in many of the city’s children, as well as an outbreak of Legionnaire’s disease. Property values plummeted and the state and federal governments were forced to spend hundreds of millions of dollars to mitigate the problem.

Now as a new President who has promised to improve the nation’s infrastructure settles into office, the question remains: Will the culture of neglect, especially regarding the health of poor people of color, continue? The answer may depend upon whether the law recognizes the protection of public health as not only a source of governmental power, but also as a duty for which officials may be held responsible. […]

Read the full post here.

TODAY, 2/13 at 5 PM! Health Law Workshop with Brandon Maher

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

Download the Presentation: “Unlocking Exchanges”

Brendan S. Maher is a Professor of Law and the Director of the independently endowed Insurance Law Center at UConn School of Law. A graduate of Stanford University and Harvard Law School, Maher is the faculty advisor for the peer-reviewed Connecticut Insurance Law Journal and a nationally recognized expert in the regulation of insurance, pensions, and health care. He is a leading authority on the meaning of both ERISA and the Affordable Care Act. Maher also teaches and studies the procedural and evidentiary aspects of civil litigation in federal courts.

Maher is an appointed member of the Connecticut Retirement Security Board, a board created by the state legislature to develop a comprehensive proposal for the implementation of a public retirement plan. He is also the co-moderator of Connecticut’s Forum on Healthcare Innovation, a forum for scholars, investors, providers, scientists, and regulators to share ideas on optimizing health outcomes. He was the chairman of the law school’s “The Affordable Care Act Turns Five” conference, where former United States Secretary of Health and Human Services Kathleen Sebelius was the keynote speaker.

Maher regularly appears before the United States Supreme Court to litigate cases involving employee benefits, preemption, and procedure. One of his cases, LaRue v. DeWolff, Boberg & Associates, was described by The New York Times as “one of the most important rulings in years on the meaning of the federal pension law known as ERISA.” He also studies and is routinely consulted by states, medical providers, and employee organizations as to the applicability of federal law to their activities.

Maher is licensed to practice in several state and federal courts, including the U.S. Supreme Court.

A New Day For Oversight Of Human Subjects Research

This new post by Holly F. Lynch appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?

First, it is important to understand where things stood. The Common Rule was initially adopted in 1991, with each relevant agency codifying the same set of regulations (the Department of Health and Human Service’s codification is found at 45 C.F.R. Part 46). The primary functions of the Common Rule are to require that research with human subjects be approved by an Institutional Review Board (IRB) and that subjects provide informed consent to research participation, with some important exceptions on each front. (FDA has similar, but not identical requirements, for clinical investigations, which are now likely to be harmonized with the new Common Rule.) […]

Continue reading here.

REGISTER NOW (2/10)! Returning Results to Research Participants: A Health Policy and Bioethics Consortium

health-policy-and-bioethics-consortium-visixREGISTER NOW! Returning Results to Research Participants: A Health Policy and Bioethics Consortium

February 10, 2017 12:30 – 2:00 PM
Wasserstein Hall, Milstein East C (2036)
Harvard Law School, Cambridge, MA

Register Now!

Clinical investigators, public health advocates, and IRBs have been struggling to develop appropriate policies on how to return results to patients involved in research studies. These results may come in a variety of forms, ranging from aggregated study results to individual results to incidental findings. Experts disagree over the optimal timing, how researchers should consider the burden that these results can place on patients, and whether there are circumstances in which certain findings should be withheld. Is clinical utility the appropriate standard, or does mere curiosity suffice to trigger disclosure obligations? How certain must the results be, and what if there is reason to believe that the results will be difficult for participants to understand – or cause them harm?  Two experts in the field of research law and ethics will join us to engage these and other questions, and help conceive a way to move forward in the best interests of patients and the medical research enterprise. Continue reading

Digital Health @ Harvard Brown Bag Lunch Series: Free Independent Health Records, featuring Adrian Gropper, MD

January 26, 2017 12:00 PM
Berkman Klein Center for Internet and Society
23 Everett St., 2nd floor, Harvard Law School, Cambridge, MA

Register for this event

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology. The series is cosponsored by the Berkman Klein Center for Internet & Society at Harvard University and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The goal of the series is to discuss ongoing research in this research area, share new developments, identify opportunities for collaboration, and explore the digital health ecosystem more generally.

These lunches are free and open to the public, but RSVPs are required. RSVP now!

This Month

Dr. Adrian Gropper is working to put patients in charge of their health records, arguably the most valuable and most personal kinds of connected information about a person. They encompass elements of anonymous, pseudonymous, and verified identity and they interact with both regulated institutions and licensed professionals. Gropper’s research centers on self-sovereign technology for management of personal information both in control of the individual and as hosted or curated by others. The HIE of One project is a free software reference implementation and currently the only standards-based patient-centered record. The work implements a self-sovereign UMA Authorization Server and is adding blockchain identity as self-sovereign technology to enable licensed practitioners to authenticate and, for example, write a compliant prescription directly into the patient’s self-sovereign health record. Continue reading

MONDAY (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. 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. Continue reading

Final Common Rule Revisions Just Published

This morning, the Federal Register posted for public inspection the final rule revising the Federal Policy for the Protection of Human Subjects (AKA “The Common Rule”).  This has been a long, long road, beginning with an ANPRM in 2011 and a massive NPRM in 2015.  The agencies clearly wanted to slide this in before the administration change on Friday, but substantial uncertainty remains.

I’ve copied the preamble’s articulation of key changes – and key proposals that have been dropped – below the fold.  But I want to briefly address the “what now?” question.  The incoming Trump administration will have its hands full with ACA “repeal and something,” so it’s hard to imagine this regulatory change will be high on the priority list, especially with some of the most worrisome proposals having been nixed already.  But the Congressional Review Act provides Congress a streamlined process to eliminate new agency rules.  Under the Act, agencies must notify Congress of new regulations, triggering a 60 legislative day review period in which Congress can pass a resolution of disapproval for presidential signature (or veto).  So that’s a possibility here.

In addition, two bills have passed the House that could impact these regulations.  First, the Midnight Rules Relief Act would amend the Congressional Review Act to allow Congress to disapprove multiple rules at once.  In other words, Congress could pass a resolution of disapproval of ALL regulations that had been recently passed to get rid of them all in one fell swoop without individual consideration.  Second, the REINS (Regulations from the Executive in Need of Scrutiny) Act, if passed, would require that “major” rules get a joint resolution of Congressional approval within 70 session days to take effect – “major” is defined as having an annual impact of $100M or more, a major increase in costs, or significant adverse effects on innovation.

Point being, don’t get too comfortable with the new rule just yet.  Key changes – and things that are staying the same – are listed below (from the Fed. Reg. notice).  And I’ll be presenting on these matters at Petrie-Flom’s upcoming conference, Health Law Year in P/Review, on Monday 1/23/17.

Continue reading

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. 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.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:05am, Welcome Remarks

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

9:05 – 10:30am: The End of ObamaCare? Health Care Reform Under A New Administration

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • David Blumenthal, President, The Commonwealth Fund
  • Michael K. Gusmano, Research Scholar, The Hastings Center
  • John McDonough, Professor of the Practice of Public Health, Director of the Center for Executive and Continuing Professional Education, Harvard T. H. Chan School of Public Health
  • Abigail R. Moncrieff, Associate Professor of Law and Peter Paul Career Development Professor, Boston University School of Law
  • Moderator: Einer Elhauge, Caroll and Milton Petrie Professor of Law and Founding Faculty Director, Petrie-Flom Center, Harvard Law School

10:30 – 10:45am, Break

10:45 – 11:10am, Precision Medicine Initiative/Cancer Moonshot

11:10 – 11:35am, Common Rule Update

  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

11:35am – 12:00pm, Clinical Trial Data Sharing

  • TBD, MRCT Center at Harvard

12:00 – 12:25pm, All-Payer Claims Databases

  • Gregory D. Curfman, Editor-in-Chief, Harvard Health Publications, Harvard Medical School

12:25 – 1:00pm, Lunch

Lunch will be provided.

1:00 – 1:25pm, Defining Death, Aid in Dying, and Family Rights

  • Paul Ford, Lecturer, Harvard Medical School, Winter 2017; Director, NeuroEthics Program, Cleveland Clinic; Director of Education, Department of Bioethics, Cleveland Clinic; Associate Professor, CCF Lerner College of Medicine of CWRU

1:25 – 1:50pm, Patient Advocacy, FDA, and Right to Try

  • Jerry Avorn, Professor of Medicine, Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

1:50 – 2:15pm, Drug Pricing and Cost

  • Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School and Brigham and Women’s Hospital

2:15 – 2:40pm, Health IP

2:40 – 2:55pm, Break

2:55 – 3:20pm, Women’s Health

  • Aziza Ahmed, Professor of Law, Northeastern University School of Law

3:20 – 3:45pm, Reproductive Technology and Regulatory Oversight

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School

3:45 – 4:10pm, Legal Responses to Zika

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

4:10 – 4:35pm, Flint, Water Safety, and Public Health Infrastructure

  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs

4:35 – 5:00pm, Concussion Litigation and Legislation in Sports

  • Christopher Deubert, Senior Law and Ethics Associate, Petrie-Flom Center Law and Ethics Initiative, Football Players Health Study at Harvard University

5:00pm, Adjourn

Learn More

How did our prognosticators do in predicting health law and policy developments they expected in 2016? Check out videos of all of the presentations at the 4th Annual Health Law Year in P/Review event, held in January 2016, and find out!

Register Now!

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

The Best-Laid Plans For Health Care

This new post by Petrie-Flom’s Faculty Director I. Glenn Cohen appears on the Health Affairs Blog as the first entry in a series that will stem from our Fifth Annual Health Law Year in P/Review event to be held at Harvard Law School on Monday, January 23, 2017.

“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title of a Steinbeck novella, may become the mantra for health policy in 2017.

The Affordable Care Act (ACA) was the largest and most ambitious alteration to American health policy in a generation. By the middle of 2016, it appeared to be largely “settling into place,” and the quartet of Supreme Court encounters with the law have by now been largely resolved. The Constitutional commerce and taxation clause challenges of NFIB v. Sebelius have been decided, with the Court weakening Medicaid expansion and causing other problems, albeit not ones that threatened the vitality of the overarching statutory scheme due to preservation of the individual mandate.

The decision in King v. Burwell left funding for the insurance Exchanges intact. Controversy over the contraceptive coverage requirements stemming from the Act remains, with the Court punting on the extent to which its analysis from Burwell v. Hobby Lobby ought to apply to challenges raised by other types of objectors in Zubik v. Burwell, leaving the litigants with a strange “Can’t you guys just work this out on remand?” sort of resolution. […]

Read the full post here!

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. 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. Continue reading