Annual Reports

In Fiscal Year 2024 (FY24), the Petrie-Flom Center took on a wide range of health law policy, biotechnology, and bioethics issues, including fully funded research initiatives on artificial intelligence in health care, digital home health, and psychedelics and the law. Our work appeared in numerous high-profile peer-reviewed journals, and we provided expertise and commentary to reporters, researchers, and others on many topics. Our digital media impact continued to grow from our increased social media presence and our successful blog, Bill of Health, and its digital symposia.

We expanded our busy event schedule to include options for all our audiences: in-person, virtual, and hybrid events, with more in-person formats planned for fiscal year 2025 (FY25). Through internships, research assistants, and especially our thriving student fellowship program, we invited students into all aspects of the Center’s research work, and provided mentorship for independent research projects to help train the next generation of health law scholars.

Our Executive Director, Susannah Baruch, who joined Petrie-Flom in June 2023, had a successful and active first year, working closely with Faculty Director, I. Glenn Cohen. With the increased workload, the Petrie-Flom Center team also grew. Laura Chong took on increased responsibility for the Center’s day-to-day and long-term operations as the Financial and Administrative Director, and Lisa Gorelik joined the team as a Program Assistant to support events, communications, and finance. Following the departure of Chloe Reichel in August 2024 we have hired a new Communications Manager who will join us in December 2024.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School

Susannah Baruch, Executive Director

In Fiscal Year 2023 (FY23), the Petrie-Flom Center took on a wide range of health law policy, biotechnology, and bioethics issues, including several fully-funded research initiatives on artificial intelligence in health care, digital home health, and psychedelics and the law. We also significantly contributed to the public conversation about access to reproductive health care after the United States Supreme Court’s decision in Dobbs v. Jackson. Our work continues to be published in numerous high-profile journals, and we provide expertise and commentary on a wide range of health law policy topics.

Executive Director Carmel Shachar moved to an exciting new role as Assistant Clinical Professor of Law and Faculty Director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation at Harvard Law School (CHLPI) and our new Executive Director, Susannah Baruch, joined Petrie-Flom in June 2023.

The Petrie-Flom Center has produced significant scholarly research while also growing our digital media impact, including our successful blog, Bill of Health, and its digital symposia program. We maintain an expansive webinar schedule and with the worst of the COVID-19 pandemic behind us, we are committed to providing in-person programming and hosting impactful convenings at Harvard Law School.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School

Susannah Baruch, Executive Director

The most significant highlight of Fiscal Year (FY22) for the Petrie-Flom Center was the successful first years of two fully funded three-year signature initiatives, one on diagnostic digital health and another on the law and regulation of psychedelics. Both projects released a tremendous amount of scholarship in high profile journals such as JAMA, Nature Medicine, and Harvard Law Review Forum. Each project hosted successful public events, such as Should Alexa Diagnose Alzheimer’s? and a Macro View of Microdosing. Our psychedelics work is so unique that noted author Michael Pollan stated that there is nothing like it at any other American university.

Other areas of specific pride for the Petrie-Flom Center also include increased digital media and event presence, our maintained connection to Harvard Law School students, and the robust inclusion of the Center’s experts in policy in media coverage. We continue to grow our digital media, including our successful digital symposia program, which hosted explorations on the interplay of adoption and abortion and international pandemic lawmaking. Our blog received over a million unique visitors this year and was quoted or linked to by outlets such as the Los Angeles Times, Washington Post, and the New York Review of Books. Center affiliates were also quoted and interviewed by leading media outlets including the New York Times, Fox News, Bloomberg News, Time, and STAT. We anticipate a similar high-profile year in FY23 as health issues, especially around reproductive rights, remain front and center.

As we chart our post-pandemic approach to engaging with our multiple audiences, FY22 was a dynamic and rewarding year for the Petrie-Flom Center. We hosted our first in person event since the start of the COVID-19 pandemic, welcoming over twenty scholars for a writers’ workshop on digital at home health products. At the end of FY22, the Center quickly responded to Dobbs v. Jackson Women’s’ Whole Health, the Supreme Court case overturning Roe v. Wade. Within days of the announcement, we hosted a panel for over 800 attendees to unpack the landmark decision. Lastly, we organized several successful private working groups, such as one gathering state Medicaid leaders to discuss supporting palliative care at home. Overall, FY22 was a year of successful launches and exciting work for the Petrie-Flom Center, in terms of projects, events, structure, and communications.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School

Carmel Shachar, Executive Director

The most significant highlight of Fiscal Year (FY21) for the Petrie-Flom Center was the launch of two fully funded three-year signature initiatives, one on diagnostic digital health and another on the law and regulation of psychedelics. The Center has a history of launching research projects right before the topic becomes “hot,” such as when we launched our exploration into health artificial intelligence right before that became one of the most popular health law topics. We hope to continue that trend with our two new projects and to further build out our research portfolio in FY22.

Other areas of specific pride for the Petrie-Flom Center also include increased digital media and event presence, our maintained connection to Harvard Law School students, and the robust inclusion of the Center’s experts in policy in media coverage. Most notably, FY21 was a year in which the Center demonstrated national thought leadership, especially regarding public health law and ethics questions relating to the COVID-19 pandemic. Center affiliates published COVID-19 related scholarship in many high-profile journals, such as JAMA and NEJM. Center affiliates were also quoted and interviewed by leading media outlets including the New York Times, Washington Post, BBC, and CNN. We anticipate a similarly high-profile year in FY22 as COVID-19 continues to raise health law, policy, and ethical questions.

In light of the changes necessitated by the COVID-19 pandemic, FY21 was a dynamic and rewarding year for the Petrie-Flom Center. Building on the lessons learned in FY20, the Center was able to successfully translate our robust portfolio of events, publications, and research to virtual settings for the entirety of FY21 and grow our sponsored project portfolio. Overall, FY21 was a year of successful launches and exciting work for the Petrie-Flom Center, in terms of projects, events, structure, and communications.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School

Carmel Shachar, Executive Director

In light of the changes necessitated by the COVID-19 pandemic, Fiscal Year 2020 was a dynamic and rewarding year for the Petrie-Flom Center. Following a productive and successful Fall, the Center was able to quickly pivot their robust Spring calendar of events, publications, and fellows to virtual settings. Overall, FY20 was a year of successful launches and exciting work for the Petrie-Flom Center, in terms of projects, events, structure, and communications.

Areas of specific pride for the Petrie-Flom Center, in light of the events in spring 2020, include our increased digital media and event presence, our maintained connection to Harvard Law School students, and the robust inclusion of the Center’s experts in policy in media coverage. These will also be our areas of focus for FY21. Upcoming highlights include: the launch of our Advisory Board, the start of a fully funded three-year initiative on diagnostic digital health, and the beginning of a podcast aimed to bring the Center’s work to a general audience.

FY20 was a year of change for the Petrie-Flom Center and beyond. With our ability to agilely pivot our program and activities, the Center has continued to fulfill our core mission in a virtual setting, which we carry on into FY21.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School

Carmel Shachar, Executive Director

Fiscal Year 2019 was a year of successful launches and exciting work for the Petrie-Flom Center, in terms of projects, events, structure, and communications. FY19 marked a year of high-profile work in an important new area of biotechnology, the application of artificial intelligence in health care, as well as development of work in an increasingly important health policy topic, delivery of health care to an aging population. We also were careful about maximizing the impact of our many events, exploring a model in which we were better able to host and influence important thought leadership at several events through use of roundtables. We were equally thoughtful regarding our own structure, launching a Health Care General Counsel Roundtable, and laying the groundwork for an Advisory Board. Reflecting our commitment to changing to meet new demands, FY19 marked a year in which we focused on our communications strategy, including relaunching our successful blog and improving our digital media presence.

Faculty Director Professor I. Glenn Cohen and Executive Director Carmel Shachar continue to work closely to promote our many ongoing initiatives and launch new projects at the intersection of health law policy, biotechnology, and bioethics. This task keeps them busy, as our sponsored research portfolio is also in an exciting state of flux. Most notably, this year marked the first full year of our Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), a five-year project funded by the University of Copenhagen’s CeBIL, the Collaborative Research Program in Biomedical Innovation Law. Our work on PMAIL was especially productive due to the hard work of our Research Fellow in Precision Medicine, Artificial Intelligence, and the Law, Sara Gerke. Artificial intelligence, especially as applied to health care, is increasingly becoming an important topic in legal and ethical work, so we are proud to establish ourselves as thought leaders on this key biotechnology topic. PMAIL continues to flourish, with increasingly high-profile potential collaborators around Harvard University and in other institutions such as Stanford University and the Massachusetts Institute of Technology asking to work with the Petrie-Flom Center on projects relating to artificial intelligence in health care.

Reflecting our commitment to health care issues that have an international impact, the Petrie-Flom Center launched the Global Health Rights Project (GHRP) in FY19. Led by Senior Fellow Alicia Ely Yamin, and in collaboration with the Global Health Education and Learning Incubator (GHELI) at Harvard University, GHRP seeks to strengthen theorization of a “right to health” under international and applicable domestic law, as well as the challenges to using human rights to advance global health justice. The Project will also explore the relationship between global economic and health governance. Yamin’s involvement with GHRP adds an important international health policy expertise to the resources available to HLS students. GHRP had a great start, with several events in FY19 and generating significant scholarship, and will bring two Mexican Supreme Court Justices to campus in Fall 2019 in addition to adding to the HLS curriculum by adding a reading group on sexual and reproductive rights.

Our other research projects also had a strong year. Our Innovative Funding Models in Translational Research Project, led by Senior Fellow Douglas Eby, brought representatives of leading research institutions such as the Broad Institute and the Dana-Farber Cancer Institute to campus in October 2018 for a sophisticated discussion of problems and opportunities created by the influx of for-profit funding and corresponding decrease of governmental funding for research. The Innovative Funding Models Project will next focus on producing a whitepaper summarizing the discussions of the working group and hosting a special event to mark the 75^th anniversary of the report that created the modern American framework for biomedical research, with Eric Lander of the Broad Institute and President Emerita of MIT Susan Hockfield tentatively committed to participating. Our Project on Law and Applied Neuroscience capped another great year with a workshop cosponsored by the Federal Judicial Center on “Science-Informed Decision Making,” which was designed to help federal criminal justice practitioners develop improved collaborative responses to individuals with mental health and substance use disorders. Our FY19 Senior Fellow on the Project, Francis X. Shen, also organized some very topical events, including panels on the Neuroscience of Hate and Trauma at the Border, while also establishing ties with the Harvard Immigration and Refugee Clinic. The Center’s strong ties in the legal and medical fields positions us to be an important leader in this field and to help influence policy to better reflect the experience of older Americans. We hope to continue to grow our law and dementia work in the coming year. Our Project on Advanced Care and Health Policy, led by Senior Fellow Mark Sterling, has helped contribute to the regulatory framework around advanced care and illness. The project hosted an important conversation on the newly announced by the U.S. Department of Health and Human Services payment models for advanced care. One of our hopes for the coming year, and a focus of planning during FY19, is to knit together our work on law and neuroscience and advanced care to look at improving the care models for patients with dementia. Considering the aging demographic of the United States, it is important to revisit the way that American delivers care for dementia patients, who are notoriously challenging and expensive for the health care system to address. We are currently searching for funders for this important work.

The Petrie-Flom Center is known for its extensive, busy, and strong events calendar and FY19 was no exception. We hosted leadership from the current Presidential Administration at our events, including the Chief Counsel of the Food and Drug Administration (and HLS alumna) at our Seventh Annual Year in P/Review and the Associate Director of Health Programs at the Office of Management and Budget at our conference, Drug Pricing Policies in the United States and Globally. The Center’s increased profile was also reflected in invitations to Center leadership and staff to join roundtables and events hosted in Washington D.C. by various federal agencies. This year we also explored an event model in which part of the day would be open to the public and part of the day would be reserved for invitation-only smaller group sessions. We used this format at events such as our collaboration with former Acting Administrator for the Centers for Medicare and Medicaid Services, Andy Slavitt, on Medicaid buy-in programs, our roundtable on American mitochondrial replacement therapy policy, and our event on payment models for advanced care. We believe this events structure allows us to serve the public by bringing them interesting programming on health law policy and bioethics issues while also directly influencing important conversations by convening key thought leaders on the subjects. We are looking forward to experimenting more with this model in FY20. Our more traditional events were also successful, with our annual conference this year focusing on consumer genetic technologies and drawing a record crowd of close to 300 attendees. The American Academy of Arts and Sciences hosted the pre-conference dinner for that event, which reflects the value that people working on biotechnology and bioethics place on the Petrie-Flom Center’s thought leadership in our field.

The Petrie-Flom Center is always looking for opportunities to strengthen the ties between HLS alumni working in health law and the HLS community, especially students. As part of our efforts to bring health care practitioners to campus, in FY19 we launched our Health Care General Counsel Roundtable, a forum for ten to fifteen leading health lawyers to come together for peer conversations and education. This Roundtable provides the opportunity for Harvard University faculty, including HLS faculty, to have small group discussions with leadership at important health care entities such as Merck Pharmaceuticals and the Memorial Sloan Kettering Cancer Center. It also provides the Petrie-Flom Center a better sense of which health law policy issues are impacting real world practice, which in turn informs our research priorities. We hope that the lessons learned in creating our Roundtable will inform our next structural project, which will be to launch an Advisory Board in FY20.

FY19 was also a year in which the Center focused on its communications strategy. To reflect our increased commitment to digital media and outreach, we changed our staffing, bringing in a Communications Manager with significant experience in digital media to replace our previous Project Coordinator. Our blog, Bill of Health, continues to be a leading forum for health law policy and bioethical perspectives from thought leaders across the country and in Europe. In particular, entries relating to the opioid epidemic and a symposium that arose from our 2019 annual conference on consumer genetic technologies have recently sparked conversations and debate. Since our major relaunch in Fall 2018, our readership has more than doubled to roughly 27,000 unique users each month. We anticipate that Bill of Health will continue to host insightful analysis from contributors at Harvard and beyond, but will build its reputation in the wider digital landscape. This refresh reflects our commitment to expanding our online presence, to allow more people to engage with us than ever before.

This year we have also been very busy in the scholarship department, publishing an array of articles in legal, medical, and bioethics journals, including in the Journal of the American Medical

Association, the Lancet, and the American Journal of Bioethics. Additionally, this was a full year for our edited volumes, as we released:

• Transparency in Health and Health Care in the United States (Cambridge University Press, June 2019).

We have also just submitted the final manuscript for Disability, Law, Health, and Bioethics, stemming from our 2018 annual conference, which will be released in the coming year. We are excited to see where our scholarship goes next, especially with our focus on artificial intelligence in health care.

Our excellent Student Fellows joined the Center from across campus and pursued projects related to the need for greater attention to scientific knowledge when shaping HIV criminalization laws, the role of face-to-face pharmaceutical advertising to doctors in the opioid epidemic, the role of public-sector research in new drug discovery, the possibility of Medicaid coverage for doula services and the potential impact on post-natal outcomes, a reconsideration of the doctrine of legal capacity as it applies to seniors, and rethinking bioethics to account for human intellectual and moral frailty. As part of our increased commitment to digital outreach, we trained our Student Fellows extensively on how to write intellectual yet accessible pieces for digital media outlets, such as our blog.

We believe great things are in store for the Center in Fiscal Year 2020. We are well positioned to continue our position as thought leaders on increasingly high-profile topics such as the use of big data and artificial intelligence in health care. We also are looking to launch the Center’s work in an increasingly important health policy topic, namely, the challenges of meeting the health care needs of our aging population. We are excited to be a venue for furthering important policy conversations through our new events model of mixing public and invitation-only sessions. We are working to build connections between legal scholars and health law practitioners, both at Harvard and beyond, through our event programming and our Health Care General Counsel Roundtable. Our commitment to refreshing our digital media presence was reflected the successful relaunch of our blog, Bill of Health, and we hope to continue to build our unique digital outreach through better use of our video archives and perhaps even podcasting in the future. To support all of these projects and programming, and to secure the future of the Center, we hope to have a successful year in fundraising and to build the Center’s base of support through an Advisory Board. The Center’s work remains strong and we are looking forward to sharing it widely through these initiatives.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School

Carmel Shachar, Executive Director

Fiscal Year 2018 was a year of exciting transitions and changes for the Petrie-Flom Center, in terms of leadership, project focus, types of events, and staffing. FY18 marked the first year of Carmel Shachar’s tenure as Executive Director. During this year the Center also launched two new initiatives and largely completed work on a third. In FY18 we also made some changes to the types of events hosted, choosing to shift to larger scale events with new partners and collaborators. We also changed our staffing, bringing in a Communications Manager with significant experience in digital media to replace our previous Project Coordinator, in part to reflect our re-commitment to a strong digital presence.

In FY18 the Center expanded its work on health law policy issues and sought to build deeper connections with health law practitioners. For example, this year marked our first event co-hosted with a law firm, Will Value-Based Care Save the Health Care System? Our partner, Ropes & Gray LLP, was integral in procuring high level industry speakers such as the Chief Medical Officer of Harvard Pilgrim Health Care and the General Counsel of Fresenius Health Care. The event brought close to two hundred scholars and health law practitioners to campus and sparked a dialog between industry and thought leaders. We hope that this event will be the first of many in which the Center facilitates a dialog between practitioners and scholars. We also anticipate that these events can serve to strengthen the ties between HLS alumni working in health law and the HLS community, especially students. Carmel is currently working to launch our Health Care General Counsel Roundtable, a forum for ten to fifteen leading health lawyers to come together for peer conversations and education. Again, the Center hopes that the Roundtable will build a bridge between the HLS campus, including students, and leaders in our field.

Carmel continues to work closely with Faculty Director Professor I. Glenn Cohen to promote our many ongoing initiatives and launch new projects at the intersection of health law policy, biotechnology, and bioethics. This task keeps them busy, as our sponsored research portfolio is also in an exciting state of flux. Most notably, this year we launched our Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), a five-year project funded by the University of Copenhagen’s CeBIL, the Collaborative Research Program in Biomedical Innovation Law. PMAIL seeks to understand the frontiers of big data in health care diagnostics through interdisciplinary analysis of important health law and policy issues. By the end of PMAIL, our goal is to produce a comparative analysis of “black box” personalized medicine, explaining the shortcomings of the current innovation policy landscape in Europe and the US and providing a comprehensive examination of various policy options to better align incentives. Artificial intelligence is increasingly becoming a high-profile topic in legal and ethical work, so we are thrilled to be diving deeply into this work. Our focus for PMAIL in FY18 was hiring a Research Fellow for Precision Medicine, Sara Gerke, who will join us for three years starting in August 2018.

We also launched the Innovative Funding Models in Translational Research Project, led by Senior Fellow Douglas Eby, to explore the regulatory and ethical challenges around the increase of for-profit funding in early stage medical and scientific research. This Project will bring representatives of leading research institutions such as the Broad Institute and the Dana-Farber Cancer Institute to campus in October 2018 for a sophisticated discussion of problems and opportunities created by the influx of for-profit funding and corresponding decrease of governmental funding for research. Both projects launched in FY18 reflect the Center’s strong and unique positioning in the health law policy and bioethics landscape. Because of our close ties to the medical research community, particularly at the Longwood Medical Area, we are well placed to identify areas of legal and ethical ferment as they initially present themselves.

Our existing research projects also had a strong year. Our collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst was very productive, generating guidance and several articles, including a New England Journal of Medicine article, on the complicated issue of compensating research subjects. Through this project we also continued to publish work on social media as a research recruitment tool and prioritizing study recruitment. And our work on the Patient-Centered Outcomes Research Oversight Study mostly finished by the end of FY18, culminating in a Delphi panel to establish consensus among expert stakeholders on key recommendations for the oversight of Patient-Centered outcomes research. The results will be published in the Annals of Internal Medicine. Both of these projects reflect our commitment to supporting ethical research, including supporting the work of researchers and the voices of research subjects.

Our more policy-oriented projects also had busy years, especially in regard to events hosted on campus. Our Project on Law and Applied Neuroscience wrapped up its fourth year with a workshop cosponsored by the Federal Judicial Center on “Tailoring Justice: Science-Informed Decision Making,” which was designed to help federal criminal justice practitioners develop improved collaborative responses to individuals with mental health and substance use disorders. Our FY18 Senior Fellow on the Project, Francis X. Shen, organized a large conference on law and dementia. Considering the aging demographic of the United States, it is important to encourage legal practitioners to better understand current medical and neuroscience frameworks when it comes to capacity to consent, aging, and dementia. The Center’s strong ties in the legal and medical fields positions us to be an important leader in this field and to help influence policy to better reflect the experience of older Americans. We hope to continue to grow our law and dementia work in the coming year. Our Project on Advanced Care and Health Policy has helped contribute to the regulatory framework around advanced care and illness. The project released a whitepaper on critical pathways to improved care for serious illness that came out of a conference hosted in FY17. We also hosted a well-attended conference on shared decision-making for advanced care that we are translating into a whitepaper and several academic articles, to reach as wide an audience as possible. One of our next goals to continue to grow this project will be to create a fellowship to bring young leaders in the field of advanced care to Harvard, both from the federal and state level. Senior Fellow Mark Sterling will continue in his inaugural role for another year.

We had an extremely busy year in term of events: we hosted eleven conferences and a number of smaller panel events, as well as providing support for events hosted by partners at Harvard Law School, Harvard Medical School, and elsewhere. The topics addressed covered the gamut of health law policy and bioethical issues: Patient-Centered outcomes research, economic ordeals in health care, dementia in our elected officials and judiciary, the cost of drugs in America, and crimes of passion among other topics. A highlight of the year was our event at HLS | 200, New Technologies, New Dilemmas, featuring Atul Gawande, Eric Lander, and Judith Edersheim along with our Faculty Director I. Glenn Cohen, to discuss the impact that breakthroughs in science have, should have, and will have on our legal and regulatory systems. As mentioned above, this year we began to strengthen our offerings for the health law practitioner community, especially HLS alumni, when we had our first collaborative event with a law firm. We collaborated with the Center for Bioethics at Harvard Medical School on a number of conferences and events, including the year-long health policy and bioethics consortium and a conference on access to care in the American prison system. We also collaborated with our friends at the Berkman-Klein Center for Internet and Society at Harvard University to continue the Digital Health @ Harvard series, which we hope to build into a larger collaboration. We hosted our 6th Annual Health Law Year in P/Review, which featured panels recapping an eventful year in health care reform with perspectives from both conservative and liberal advocates from Washington D.C. This year’s annual conference, hosted in collaboration with the Harvard Law School Project on Disability, explored the framing of disability in the medical and legal fields.

This year we have also been very busy in the scholarship department, publishing an array of articles in legal, medical, and bioethics journals, including in the New England Journal of Medicine. Additionally, this was a full year for our edited volumes, as we released:

• Law, Religion, and Health in the United States (Cambridge University Press, July 2017),
• Specimen Science: Ethics and Policy Implications (MIT Press, October 2017), and
• Big Data, Health Law, and Bioethics (Cambridge University Press, March 2018).

We have also just submitted the final manuscript for Transparency in Health and Health Care, stemming from our 2017 annual conference, which will be released in the coming year. We are excited to see where our scholarship goes next, especially with our new focus on artificial intelligence in health care.

Our excellent Student Fellows joined the Center from across campus and pursued projects related to the perspectives of mental health providers on mental health apps, bioethics in the Islamic tradition, the regulation and theology of Christian health care ministries, and the rights of the fetus in Irish law. Our Bill of Health blog continues to be a leading forum for health law policy and bioethical perspectives from thought leaders across the country and in Europe. In particular, entries relating to the opioid epidemic and vaccine policy have recently sparked conversations and debate. Although it is very popular, with over 970,000 unique users visiting since 2012 and 17,000 page views per month, we are in the midst of planning a major relaunch for the blog, to be supported by our new Communications Manager. We anticipate that Bill of Health will continue to host insightful analysis from contributors at Harvard and beyond, but will build its reputation in the wider digital landscape. This refresh reflects our commitment to expanding our online presence, to allow more people to engage with us than ever before.

We believe great things are in store for the Center in Fiscal Year 2019. We are well positioned to be thought leaders on an increasingly high-profile topic, the use of big data and artificial intelligence in health care, and hope to use that project as a springboard to work more in the field of digital health. We also are looking to launch the Center’s work in several important health law policy areas, including the treatment of aging individuals with dementia and the impact of the opioid epidemic. We are excited about a potential collaboration on the topic of value-based health care with our colleagues at Harvard Business School. We are working to build connections between legal scholars and health law practitioners, both at Harvard and beyond, through our event programming and our Health Care General Counsel Roundtable. Our commitment to serving a broad audience is also reflected in our soon-to-be launched refresh of our successful blog, Bill of Health, which we believe will help amplify the work of Center staff and students. To support all of these projects and programming, and to secure the future of the Center, we hope to have a successful year in fundraising. The Center’s work remains strong and we are looking forward to sharing it widely through these initiatives.

With sincere thanks to everyone who supports our work,

I. Glenn Cohen, Faculty Director & Carmel Shachar, Executive Director

Summer 2017 marked the start of an exciting new era at the Petrie-Flom Center, as we welcomed Carmel Shachar to our Leadership team. Carmel joined the Center in June as our new Executive Director, succeeding Holly Fernandez Lynch, who served in the role since 2012. Holly, a member of the Center’s inaugural cohort of Academic Fellows in 2006, will join the Department of Medical Ethics and Health Policy at the University of Pennsylvania’s Perelman School of Medicine as Assistant Professor in Fall 2017. Carmel earned both her J.D. and M.P.H. from Harvard, was a Petrie-Flom Center student fellow in 2008–2009, and joins us from the law school’s Center for Health Law Policy and Innovation. With expertise in health policy, and in particular the regulation of access to care for vulnerable individuals, health care anti-discrimination law and policy, and the use of all-payer claims databases in health care research, Carmel is well-poised to guide the Center through a new bout of national health reform. Carmel will join Faculty Director Professor I. Glenn Cohen to continue our many ongoing initiatives and launch new projects at the intersection of health law policy, biotechnology, and bioethics.

We are also thrilled to announce that we successfully wrapped our work on the Law and Ethics Initiative of the Football Players Health Study this academic year, publishing a 493-page comprehensive analysis of the legal and ethical responsibilities of various stakeholders capable of protecting and promoting player health and well-being. The report includes 76 recommendations for improvement and was accompanied by a conversation with relevant stakeholders in the Hastings Center Report regarding our primary recommendation to address the conflicts of interest inherent in the current structure of player medical care. In addition, we published a comparative analysis of the major professional sports leagues to assess what lessons could be imported to the NFL to improve player health, as well as an article in the University of Pennsylvania Law Review analyzing the potential for various health and performance-related tests of NFL players to violate the protections offered by disability law, privacy law, and law governing genetic testing. Additional publications from the project are forthcoming. The work has garnered national media attention from the Boston Globe, STAT News, the Washington Post, and other outlets. We are very proud of this unique project, and hope that our work will bring attention to the structural factors that influence player health.

Our other sponsored research projects also enjoyed a productive year. We continued to make progress on ways to improve recruitment to clinical trials, in collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, generating guidance and an academic article on the use of social media for recruitment, hosting a symposium on the ethics of payment to research participants, and evaluating ways to prioritize trials that might compete with one another for the same group of eligible patients. And our work on the Patient-Centered Outcomes Research Oversight Study completed its phase of qualitative interviews with thought leaders in the field, and launched its survey of Institutional Review Board chairs to better understand the key issues in the ethical review and oversight of research that engages patients in non-traditional roles.

Next year, pending final approval between the relevant entities, we are looking forward to launching a new collaborative project spearheaded by one of our former Visiting Scholars, Timo Minssen from the University of Copenhagen Faculty of Law. The project is called CeBIL, the Collaborative Research Program in Biomedical Innovation Law, and it aims to contribute to the translation of groundbreaking biomedical research into safe, effective, affordable and accessible therapies by analyzing the most significant legal challenges to pharmaceutical innovation and public health from a holistic cross-disciplinary perspective. Funded by the Novo Nordisk Foundation, CeBIL will propose new frameworks for drug development incentives and regulations that take into account patient-needs, access aspects, market complexities, and economic sustainability. Petrie-Flom will serve as a key partner in the collaboration, leading a comparative analysis of “black box” personalized medicine, explaining the shortcomings of the current innovation policy landscape in Europe and the US, and providing a comprehensive examination of various policy options to better align incentives. Former Petrie-Flom Center Academic Fellows Jeffrey Skopek and Nicholson Price will also collaborate on the project at their new respective home institutions, University of Cambridge (UK) and University of Michigan, as will Petrie-Flom Center faculty affiliate Aaron Kesselheim of Harvard Medical School.

Our Project on Law and Applied Neuroscience is going strong, wrapping up its third year with a workshop co-sponsored by the Federal Judicial Center on “Tailoring Justice: Science-Informed Decision Making,” designed to help federal criminal justice practitioners develop improved collaborative responses to individuals with mental health and substance use disorders. In Fall 2017, we look forward to welcoming our new Senior Fellow on the Project, Francis X. Shen who will visit us from the University of Minnesota Law School for the year.

The first year of our Project on Advanced Care and Health Policy has also helped facilitate the Center’s relationship with health policymakers, health care providers, and legal practitioners through a host of public events and workshops focused on mechanisms to improve care for serious illness. Senior Fellow Mark Sterling will continue in his inaugural role for another year, as we work to develop publications and additional projects out of the collaboration.

As always, we have kept our community busy with a slate of fascinating public events this year, covering the ethical involvement of patients in FDA review of new drugs, concerns surrounding concurrent surgeries, juvenile sentencing and neuroscience, health policy and the presidential election, approaches to biosimilar regulation, opiate regulation, crowdfunding medical care, gun control and responses to community violence. We were lucky enough to host William B. Schultz, former general counsel of the U.S. Department of Health and Human Services (2011-2016), for a candid lecture, and we also hosted our first ever webinar, on President Trump’s health policy agenda. We collaborated with the Harvard Medical School Center for Bioethics on a number of conferences and events, including the year-long health policy and bioethics consortium and a symposium on the ethics of early embryo research. We also collaborated with our friends at the Berkman-Klein Center to launch the Digital Health @Harvard brownbag lunch series, bringing together interested individuals from all pockets of the university doing related work in this space. We hosted our 5th Annual Health Law Year in P/Review, along with another successful online symposium at the Health Affairs blog, and this year’s annual conference focused on transparency in health and health care.

We have, of course, been active in the scholarship department, publishing an array of articles in legal, medical, and bioethics journals, in addition to several edited volumes. This year, we released Nudging Health: Health Law and Behavioral Economics (Johns Hopkins University Press), and put the finishing touches on two volumes that will be released this year: Law, Religion, and Health in the United States (Cambridge University Press, July 2017), and Specimen Science: Ethics and Policy Implications (MIT Press, October 2017). We have also just submitted the final manuscript for Big Data, Health Law and Bioethics, stemming from our 2016 annual conference, which should be released in early 2018.

Our fabulous student fellows joined the Center from across campus and pursued projects related to organ donation policy, intellectual property, health solidarity, and the neuroscience of eye witness testimony, while our student contributions to the Journal of Law and Biosciences covered gender in professional sports, amnesia and criminal responsibility, drug prices, and lab-developed genetic tests. Our Bill of Health blog is now firmly established as a leading source of intellectual and policy insight in the realm of health care and bioethics, with 15,000 unique users each month. The blog even earned a “shout out” from Steve Usdin, Washington Editor of BioCentury, as “very influential.” Bill of Health continues to host insightful analysis from contributors at Harvard and beyond, as well as online symposia on a range of cutting edge topics, including emerging infectious disease, citizen science, and employment discrimination based on health status. And our online presence is broader than ever, with more people around the world engaging with us and our content through social media than ever before.

We are excited to embark on this next chapter in Petrie-Flom history. The Center is well positioned to emerge as a thought leader in health law policy during this new turbulent phase in American health care politics. In addition to maintaining its strengths in clinical research ethics and other longstanding areas of core competency, the Center will use its bioethical expertise in projects designed to further a better understanding of ethical health care access. We are also planning to thoughtfully expand the Center’s capacity through several new initiatives. One of these will be to begin creating an advisory board, to better expand the resources that the Center can bring to the projects it explores. Another of these new initiatives will be to consider relaunching the academic fellowship as an incubator program for the next generation of health care policy leaders. We are eager to see the Center continue to grow over the next few years as it rounds out its health law policy projects in addition to its bioethics portfolio and continues to thoughtfully add to its family through bold new initiatives.

Every year, the Petrie-Flom Center seems to be more abuzz with activity – events, scholarship, sponsored research, and new collaborations – and this year was no exception. While we pride ourselves on constant forward motion, it is nice every now and then to reflect on where we have been and what we have accomplished so far. The process of writing each year’s annual report allows us to do just that, but this year, we also had the wonderful opportunity to celebrate the Center’s first decade with a banner event on the Future of Health Law and Policy, featuring commentary from prominent HLS alumni and our accomplished network of former Center fellows, who are now spread all over the country and beyond. This celebratory conference highlighted the impact the Center has had on health law, policy, and bioethics, and its extraordinary reputation as a leader in these fields (watch the short video here).

Never ones to stop moving, we also used the conference as an opportunity to unveil our plans for the Center’s second decade, during which we hope to expand our capacity to influence policymaking by establishing several new Topical Programs – Law and Bioethics; Health Care Delivery and Finance; and Medical Innovation and Law – that will provide independent expert analysis, policy recommendations, empirical research, and practical solutions to pressing issues, in the form of policy briefs, white papers, model legislation, public commentary, and real-time responses to emerging issues and opportunities. We are actively engaged in fundraising activities to help make this vision a reality.

The Center’s sponsored research portfolio made substantial progress this year. The Law and Ethics Initiative of the Football Players Health Study at Harvard is gearing up to launch a series of reports beginning in Fall 2016 through 2017 focused on structural mechanisms to improve the health of professional football players, including an extensive set of recommendations for various stakeholders to support this goal. Our work as part of Harvard Catalyst’s Regulatory Foundations, Ethics, and Law Program has made strides toward improving recruitment to clinical research by generating guidance on how to ethically utilize social media tools for recruitment, evaluating the parameters for ethical payment of research participants, and considering the need to prioritize studies that compete for the same pool of potential participants, as well as launching new projects related to recruitment to biobanking studies, among others. We also launched a new sponsored research project focused on assessing ethical and regulatory oversight issues in patient-centered research, and developing recommendations for Institutional Review Boards as they are increasingly called on to review such studies. Each of these projects will continue through the next fiscal year.

Our collaboration with the Center for Law, Brain and Behavior at Massachusetts General Hospital, the Project on Law and Applied Neuroscience, continued for its second year with a focus on neuroscience and juvenile justice. We also launched a parallel program, the Project on Advanced Care and Health Policy, with collaborators at the Coalition to Transform Advanced Care; this new Project seeks to study and foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, and to apply interdisciplinary analysis to important health law and policy issues raised by the adoption of new person-centered approaches to care for this growing population. In addition, our collaboration on the Journal of Law and the Biosciences continues, as the Journal has quickly become a leading source of cutting-edge, interdisciplinary scholarship in the field. Similarly, our collaborative, interdisciplinary blog, Bill of Health, remains a go-to source for real-time commentary and scholarly insights on range of health policy and bioethics issues, with increased attention from news media and others leading to press interviews and scholarly collaborations.

The Center’s public events schedule was packed as always, with panel discussions, lectures, conferences, and workshops on a wide range of topics, including law and neuroscience, animal research, synthetic biology, bioenhancement, regulation of pharmaceutical products, fetal pain, research with biospecimens, advanced care policy, consumer models of health care, and non-invasive prenatal diagnosis, among others. We hosted national policymakers, including Margaret (Peggy) Hamburg, former FDA Commissioner, and Donald Berwick, former administrator of the Center for Medicare and Medicaid Services, as well as Andrew Dreyfus, President and CEO, Blue Cross Blue Shield of Massachusetts. This year’s annual conference, Big Data, Health Law, and Bioethics, sparked collaboration with the Berkman Klein Center for Internet and Society at Harvard and the Health Ethics and Policy Lab at the University of Zurich.

Many of our larger events result in publications, including edited volumes from academic presses. FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies, stemming from our 2013 annual conference, was released in Fall 2015, and Nudging Health: Health Law and Behavioral Economics, stemming from our 2014 annual conference, will be released this Fall. We are also in the midst of completing work on two additional volumes, Specimen Science: Ethics and Policy Implications and Law, Religion, and Health in the United States, for release in 2017.

Our affiliates continue to make important contributions to the teaching curriculum, with courses on health law policy and bioethics, medical innovation, and law and neuroscience. They are also prolific scholars, writing on such topics as religious freedom and health care, biospecimen research, reproductive technologies, health law policy, suicide risk, electronic health technologies, insurance, innovation law, neuroscience, research ethics, food and drug law, and more. Our departing Academic Fellow, Rachel E. Sachs, secured a phenomenal placement as a tenure-track professor at Washington University in St. Louis School of Law, and our Student Fellows developed scholarly contributions in the areas of food and drug law, genetic privacy, Medicaid policy, and intersex rights. A number of other students engaged substantively in Center projects as research assistants.

In the 2017 Fiscal Year, we look forward to continuing our core work related to sponsored research, scholarship, policy work, teaching and mentoring students, public engagement, and other collaborations, as well as making new strides toward our next phase of growth and development.

This year marks the close of the Petrie-Flom Center’s first decade of existence, and we are thrilled with what we have been able to accomplish in that time. The Center began with a focus on developing new scholars and scholarship in the fields of health law policy, biotechnology, and bioethics through fellowship programs for students and post-docs, as well as a handful of events and conferences. Since then, our goals have expanded dramatically to include not only these important academic pursuits, but also policy impact through sponsored research collaborations bridging legal, medical, and other disciplines. Most notably, we are no longer only a research program comprised solely of individuals working on their individual projects, but rather a true Center made up of collaborators working on Center-based research with high impact and visibility.

In terms of sponsored research, we have made substantial progress this year on our work leading the Law and Ethics Initiative of the Football Players Health Study at Harvard. In addition to providing guidance regarding legal and ethical issues that arise in other aspects of the study, we are drafting several reports and recommendations aimed at improving player health and well-being using the tools of law and ethics to complement clinical interventions. We have also continued our work with Harvard Catalyst’s Regulatory Foundations, Ethics, and Law Program, hosting an international conference to develop a research agenda around improving recruitment to clinical trials, developing guidance for the use of social media in recruitment efforts, and conducting empirical research regarding perceptions of offers of payment to research participants. Work on both of these projects will continue through the next fiscal year.

We have also launched a new sponsored-research collaboration with colleagues at Case Western Reserve University and Harvard Catalyst, funded by the National Human Genome Research Institute at the National Institutes of Health (NIH). This project involves a conference slated for Fall 2015 and a subsequent edited volume examining the legal, ethical, and practical issues surrounding research with human biospecimens, a critical step for advancing precision medicine.

In September 2015, we will add another sponsored project to our repertoire, this one funded by the Patient-Centered Outcomes Research Institute (PCORI). Collaborating with colleagues elsewhere at Harvard, our work on this project will focus on developing guidelines and recommendations for Institutional Review Boards, investigators, and patient advisors to employ when designing or reviewing human subjects research aspects of patient-centered outcomes research and comparative effectiveness research.

With regard to programmatic collaborations, we are proud to have another volume of the Journal of Law and Biosciences under our belt, alongside our partners at Duke and Stanford. This peer-reviewed, open access interdisciplinary journal from Oxford University Press features world-class scholarship, responsive commentary, and “Notes and Developments” from graduate students at each of the collaborating schools. The first year of our Project on Law and Applied Neuroscience was a resounding success, with a prolific senior fellow and a wide range of well-attended events on the law’s intersection with the neuroscience of pain. We look forward to welcoming a new senior fellow this fall, and turning the focus to neuroscience and juvenile justice. The Food Law Lab continues to grow, with important events and course offerings for students. And finally, we continue extensive collaboration with our friends at the Center for Bioethics at Harvard Medical School, co-organizing events and conferences, and most recently, the launch of their Master’s of Bioethics in Fall 2015.

The Center’s public events schedule was again packed and popular, from short panel discussions to conferences spanning several days. This year, we hosted events on human subjects research, FDA regulation, law and pain, the role of the family in medical decisionmaking, the Affordable Care Act, reproductive technology, medical tourism, Ebola and measles outbreaks, food law and policy, neuroscience and responsibility, and gender reassignment, to name a few. Our 2015 annual conference addressed issues at the intersection of Law, Religion, and Health, and we have several book projects in the works from prior conferences including others on FDA law and applying behavioral economics to health policy.

The Center’s biweekly Health Law Policy Workshop once again featured the interdisciplinary scholarship of leading academics, and Center affiliates made important contributions to the Law School’s health law curriculum, offering seminars on comparative professional responsibility for doctors and lawyers, the Affordable Care Act, and law and neuroscience.

Our Petrie-Flom affiliates have also fared well this year, with an impressive variety of publications and media commentary in leading outlets and collaborative volumes, covering such topics as medical tourism, the contraceptives coverage mandate, reproductive technology and freedom, blood donation regulation and organ markets, mobile health technologies, the Affordable Care Act, pharmaceutical pricing and innovation, procedural issues regarding Medicare claims, and the microbiome. Our departing Academic Fellow has returned to the Department of Justice to work on ongoing issues related to the Affordable Care Act and legal challenges to the Medicare Program, and our current Academic Fellow is poised to enter the law teaching market this fall. Although we do not plan to accept any additional Academic Fellows at this time, we are considering alternative ways to bring in promising post-doctoral and other fellows.

Our student fellowship continues to be an important component of the Center, and this year’s fellows – representing HLS, HMS, HDS, and FAS – pursued projects on concussions in college sports, funding for global aid, regulation of tissue donation and payment, neuroimaging and criminal justice, transgender health, and vaccine exemptions. We also worked with several HLS students as research assistants on our sponsored research and other projects.

The Center’s outreach has been expansive this year, reaching unprecedented numbers of interested people through our website, blog, social media outlets, and bi-weekly newsletter. In fact, Bill of Health – now entering its fourth year – has cemented its place as a leading source of commentary from health law scholars, with nearly 18,000 unique users each month.

In the 2016 Fiscal Year, we look forward to continuing our sponsored research projects, supporting our Academic Fellow on the teaching market, welcoming a new crop of student fellows and visitors, and hosting a range of exciting events and conferences. We have steadily expanded for the past three years, and currently plan to focus on stabilization and successful execution of our existing projects, as we gear up for a fundraising push to support our next phase of growth and development.

Our sincere thanks to everyone who supports our work. We look forward to what the next year – and decade – will bring!

We can easily say that this year was the Petrie-Flom Center’s best yet. We launched two new sponsored research programs – one with Harvard Catalyst to address legal and ethical issues related to clinical and translational research, and one focused on resolving some of the most pressing legal and ethical issues that impact the health and welfare of professional football players – and we dramatically expanded our staff in order to keep up, welcoming two new Senior Associates and two part-time support staff. In addition, this year marked the beginning of our collaboration with Stanford and Duke to publish the JOURNAL OF LAW AND BIOSCIENCES, a peer-reviewed, open access interdisciplinary journal from Oxford University Press featuring world-class scholarship, responsive commentary, and student-written current event highlights. We are also pleased to welcome Professor Jacob Gerson’s Food Law Lab under our umbrella as it got underway this year.

The Center unveiled an extensive new website featuring a range of resources for individuals interested in our fields, including news and announcements about our Center and its activities, a news feed of current health policy stories making headlines around the world, available job openings and other opportunities at Petrie-Flom and elsewhere, primers on key bioethics and health policy topics, and a compilation of curricular and other resources for individuals at Harvard. Our popular blog, Bill of Health, is stronger than ever with nearly two years under our belt, frequent contributions from leading scholars, about 12,000 visitors each month, and readers in nearly 200 countries around the world.

Our bread-and-butter programs have also fared well. Each year, we host Academic Fellows (post-doctoral) who are preparing to enter the law school teaching market, several Harvard graduate student fellows and visiting scholars who are pursuing independent scholarly projects, and a number of student interns. We are also lucky to boast an impressive array of affiliated faculty from around the University. Our two departing Academic Fellows received tenure-track positions at the University of New Hampshire and the University of Cambridge, and produced world-class scholarship on innovation policy and anonymity. Several of our student fellows saw their papers published in leading outlets, and our visiting scholars made the most of their time through extensive networking, collaborative writing, and participation in Center events. And of course, our faculty leadership continued to be prolific scholars, publishing books and articles on topics ranging from medical tourism to reproductive technology to pharmaceutical patent policy and more. Center affiliates were published in leading journals, including Health Affairs; The Harvard, University of Chicago, UCLA, Fordham, and Boston College Law Reviews; The Journal of Law and Contemporary Problems; The Yale Journal of Health Policy, Law, and Ethics; The American Journal of Law and Medicine; The Journal of Law, Medicine, and Ethics; The New England Journal of Medicine; JAMA; The American Journal of Bioethics, and more. Center affiliates were also routinely sought out by the media to offer commentary and guidance on news stories in our fields, especially the mounds of litigation related to the Affordable Care Act.

The Center’s public events schedule was again packed and popular, from short panel discussions to conferences spanning several days. This year, we hosted events on behavioral economics, pharmaceutical policy, biopatent law, mental health, food law, animal ethics, reproductive rights, and health law and bioethics careers, to name a few. The edited volume from our 2012 annual conference, HUMAN SUBJECTS RESEARCH REGULATION: PERSPECTIVES ON THE FUTURE, was released by MIT Press in July 2014, and we are nearing submission of the manuscript for the volume from our 2013 conference on the Food and Drug Administration (to be published by Columbia University Press).

The Center’s biweekly Health Law Policy Workshop once again featured the interdisciplinary scholarship of leading academics, and Center affiliates made important contributions to the Law School’s health law curriculum, offering seminars on genetics and law, “ambiguous entities” in bioethics and law, and comparative professional responsibility for doctors and lawyers.

We anticipate that next year will be even better for the Center, save for the departure of our former Faculty Co-Director, Benjamin Roin, who is now at MIT Sloan. Professor Roin remains affiliated with the Center as a visiting scholar and affiliated faculty. We will launch a new collaboration with the Center for Law, Brain, and Behavior to host the Program on Law and Applied Neuroscience, and will continue our work on other sponsored research projects. Our current Academic Fellows are poised to do well on the law teaching market, we look forward to welcoming a new crop of student fellows and visitors, and our events schedule is already shaping up to feature a range of collaborations and commentary on everything from post-trial access to the legal and ethical issues faced by intersex individuals. We are nearing a contract with Johns Hopkins University Press on the book proposal stemming from our 2014 annual conference on Behavioral Economics, Law, and Health Policy, and already planning for next year’s conference on Law, Religion, and Health Care.
We look forward to building and continuing our substantial collaborations with colleagues at the Schools of Medicine, Public Health, Government, and in particular, to working with the HMS Center for Bioethics to launch a new Master’s degree in bioethics, featuring a health law and policy track run though the Petrie-Flom Center.

Our sincere thanks go out to everyone who supports our work. We can’t wait to see what the next year will bring!

Once again, we have had a great year at the Petrie-Flom Center, continuing several of our successful programs, and initiating a variety of new projects and collaborations.

As in the past, we hosted a full schedule of events relating to pressing issues in health law policy, biotechnology, and bioethics, including health care reform, the NIH public access policy, advances in HIV prevention, legal responses to human rights violations in clinical research, stem cell therapy and medical tourism, definitions of personhood, personalized medicine patenting, and informed consent in managed care settings, as well as career events for students and a celebration in honor of our colleague, Peter Barton Hutt. Our annual spring conference brought together leading academics, practitioners, and policymakers concerned with the plight of the Food and Drug Administration in the 21st Century, and we also hosted conferences, workshops, and meetings on institutional financial conflicts of interest, key developments in health law, life sciences industry compliance, evidence-based policymaking, and clinical trial data sharing. As has become tradition with our annual conferences, we are nearing completion of the edited volume from our 2012 conference on the future of human subjects regulation, to be published by MIT Press, and are in the process of seeking a publisher for a volume stemming from this year’s conference on the FDA.

The Health Law Policy and Bioethics Workshop continues to provide a forum for premier scholars from a variety of disciplines to present and develop new scholarship in the field, while exposing students to cutting-edge ideas and leading academics from around the country. Further, Petrie-Flom affiliates continue to contribute to the HLS health law curriculum through seminars and reading groups for students interested in the field.

Students also have the opportunity to engage more directly with the Center through our graduate student fellowship program, which offers substantial mentorship in the development of publishable scholarship, as well as our newly launched student internship program. The Center’s 2012-2013 student fellows tackled topics as varied as biotechnology patents, clinical research, cyber-attacks on medical devices, health worker brain drain, and research misconduct, and enjoyed success placing their articles in law journals. Our interns helped us develop several new resources for students, including compilations of related programs around Harvard and new substantive materials for our website.

Petrie-Flom faculty and Academic Fellows continue to proliferate leading scholarship and commentary, placing their work in prestigious law reviews (Journal of Empirical Legal Studies, Journal of Legal Analysis, Administrative Law Review, Minnesota Law Review, Cornell Law Review, UCLA Law Review, Fordham Law Review, Boston College Law Review, Yale Journal of Health Policy, Law, and Ethics, Journal of Law, Medicine, and Ethics); top medical, bioethics, public health, and science journals (American Journal of Bioethics, New England Journal of Medicine, British Medical Journal, Journal of the American Medical Association, Science, Hastings Center Report, Reproductive Biomedicine, Ethical Perspectives); and leading presses (Oxford University Press, MIT Press). They were also called on by nearly every major media outlet to offer their perspective on policy issues and news items, and did so through a host of interviews and Op-Eds. Their published work in the past year covered topics including human subjects research, biotechnology patents and intellectual property, reproductive technology, medical tourism, the globalization of health care, rationing and resource allocation, medical training, health care reform, stem cell research, conscientious objection, discrimination in health care, genetics, incidental research findings, evidence-based policymaking, pharmaceutical manufacturing, and anonymity.

Ongoing faculty projects include work on medical tourism, organ markets, human subjects research, resource allocation, incentivizing pharmaceutical innovation, health care reform, and the FDA. Meanwhile, the Center’s Academic Fellows are currently working on projects related to health insurance disputes, anonymity, biotechnology and surveillance/identification, intellectual property incentives, and personalized medicine. Two of our fellows will be on the entry-level law teaching market this fall.

In addition to these stable activities, the Center undertook a variety of new initiatives in the past academic year. We launched a new collaborative blog, Bill of Health, which has had nearly 85,000 unique hits since going live in September 2012 and is enjoying success as a destination for discussion of issues related to health law policy, biotechnology and bioethics. We also began the process of launching a new peer-reviewed, open access journal with Duke and Stanford Law Schools, Journal of Law and Biosciences, which will have some student contributions in the form of “new developments” and is set to launch in the next several months. And we worked with collaborators at Harvard Medical School to pursue two new sponsored research projects that should begin shortly and will allow for expansion of the Center and its policy work: a Clinical and Translational Science Award from the National Institutes of Health to reduce barriers to engagement and conduct of clinical and translational research, and a contract with the National Football League Players’ Association to advance the health and welfare of professional football players. We may also pursue additional grant funding as opportunities arise.

Our Faculty Co-Director, I. Glenn Cohen, received tenure effective July 2013 and is now a full professor of law at HLS. We look forward to his continued leadership as we maintain our current programs, further implement these new initiatives, and work to build the Center and its influence through a variety of additional projects. For example, in the coming year, we plan to cultivate a group of affiliated faculty around Harvard doing work in our areas of focus (full list below), welcome additional scholarly visitors to the Center, launch a brand new website that will endeavor to become a leading resource in the field, and embark on several new collaborations related to state-level health policy, food and drug law, and neuroscience.

This report describes the past year’s accomplishments in greater detail, and briefly outlines plans for next year’s programming and potential areas of expansion.

This has been another fantastic year for the Petrie-Flom Center and for health law, health policy, bioethics, and biotechnology at Harvard Law School.

The Affordable Care Act was a major focal point for the Center, and is likely to be next year as well, as we contemplate the impact of the Supreme Court’s ruling on the constitutionality of the law. Our affiliated faculty led public discussion of this issue, publishing commentary in a variety of news outlets from The New Republic and The New York Times to The New England Journal of Medicine. We also hosted a number of events discussing aspects of the Act, its legal status, and its current and future implementation.

The Center’s Annual Conference also took on a topic of substantial relevance and urgency, although one that has received far less media attention than health care reform: the regulation of human subjects research. In response to a number of signals that this issue was ripe for reconsideration, we brought together more than 80 leading thinkers on the subject to provide reflections and advice to the Department of Health and Human Services as it undertakes a revision of the main federal rules governing such research.

Other events addressed such wide-ranging issues as the ethics of embryo-destructive research, resource allocation to identified versus “statistical” persons, non-gendered parenting, and the constitutional foundations of bioethics. In addition, we were fortunate to work again with the Federal Judicial Center to provide training to federal judges, this time by focusing on health policy aspects of offender re-entry and reducing recidivism. We also partnered with the Autism Self-Advocacy Network on ethical, legal, and social implications of autism research. And our Health Law Policy Workshop continued to provide the premiere forum to develop new scholarship in this field, while exposing students to cutting-edge ideas and leading academics from around the country.

Once again this year, Center faculty and fellows have successfully placed their scholarship with a number of prestigious law reviews (at Cornell, Minnesota, Georgetown, Virginia, and Yale); top medical, bioethics, public health, and science journals (The American Journal of Transplantation, Developing World Bioethics, The American Journal of Public Health, The Hastings Center Report, The Journal of Medical Ethics, Genome Research, Genetics in Medicine, and Nature Reviews Genetics); and leading academic presses (Oxford University Press). Their published work covered everything from regulating reproduction and medical tourism, to organ sale and unethical research with human subjects, to ethical issues in genetic research and conflicts of interest in biomedical academic-industry relationships.

Ongoing faculty projects include work on medical tourism, patent settlements between innovators and generics, human enhancement, patent law, and pharmaceutical innovation. Meanwhile, the Center’s Academic Fellows are currently working on projects focused on anonymity in various legal domains, reproductive ethics, and several issues related to human subjects research. We look forward to supporting these fellows
on the academic job market this fall, and to welcoming a new fellow this summer.

Finally, our student fellows continue to produce top-notch scholarship, with papers on diverse subjects including the commercialization of health technology, the organization and regulation of surrogacy brokerages, conflicts of interest in pharmaceutical marketing, distracted driving laws, and genetically modified crops.

We are expecting another outstanding year in 2012 -2013. On November 2, 2012, we will host a major event on Institutional Financial Conflicts of Interest in Research Universities, featuring among others NIH Director Francis Collins and former Harvard President Derek Bok. With the help of our new Executive Director, Holly Fernandez Lynch, we plan to launch several new initiatives that we hope will further extend the great work done by our students, faculty, and university.

This report describes this year’s accomplishments in greater detail, and briefly outlines plans for next year’s programming and potential areas of expansion.

2010-2011 has been another successful year for the Center, as we further advanced our position as the preeminent academic institution examining how law intersects with health care, bioethics, and biotechnology. That success was, however, tinged with sadness by the news of Joe Flom’s passing. The Center is the realization of the vision that Joe and the Petrie Foundation set out for the Law School, and we remain grateful for his foresight and generosity. We are proud to carry forward the mantle of his name.

Our academic fellowship program, offering two years of support and mentorship for post- graduates, continues its remarkable record as a pipeline to top academic positions in health law. After turning down several other offers, our outgoing fellows ultimately accepted professor appointments at the law schools at Cornell and the University of Illinois, adding to the Center’s prior placements at Harvard, UC Berkeley, UCLA, Boston University, and the University of Arizona. Our current academic fellows are working on papers in topics such as rethinking conflicts of interest policies in academic medicine and reforming human subjects protection, and we are excited to welcome in two additional fellows beginning this summer.

Our fellows and faculty published or have forthcoming award-winning work not only in the leading law reviews, but also in medicine (The New England Journal of Medicine), science (Nature, Cell), economics (The American Economic Review), and bioethics (The American Journal of Bioethics, The Hastings Center Report).

Our student fellows continue to produce impressive work on a broad range of issues in health law, bioethics, and biotechnology. The intensive mentorship from Petrie-Flom affiliated faculty and from our academic fellows continues to pay dividends in improving the quality of these students’ work and enabling them to publish while still enrolled students.

We held three important closed-door meetings this year. A one-day conference on the repeal of the McCarran-Ferguson Act, which exempts insurance companies (including health insurance companies) from several elements of federal antitrust regulation. The conference brought together academics working in business schools, law schools, and economics departments from around the country in discussions with practicing antitrust and health care lawyers and advocacy groups.

We also collaborated with the Federal Judicial Center, the American Association for the Advancement of Science, the Federal Judicial Center, the National Center for State Courts, the American Bar Association Judicial Division, and the Dana Foundation to host a two- day training session for approximately 40 federal and state judges on the most recent research in neuroscience and what impact it may or may not have for the law.

Our annual conference continued the tradition of bringing together leading thinkers from a across the globe, this time to wrestle with one of the most challenging issues in health law, bioethics, and biotechnology: its globalization. The Globalization of Health Care: Legal and Ethical Challenges brought together experts from practice and academia, working in fields that included law, philosophy, medicine, public health, government, anthropology, and geography, which produced an event that crossed borders and paradigms to gain insight on the vexing questions emerging from this rapidly changing field. The conference tied together the manifestation of this globalization in four related subject areas – medical tourism, medical migration (the physician “brain drain”), telemedicine, pharmaceutical research and development – and integrated them with a philosophical discussion of issues of justice and equity relating to the globalization of health care and the public health governance issues involved. Oxford University Press will publish a volume of the conference papers edited by Petrie-Flom Faculty Co-Director, I. Glenn Cohen.

Health care reform continued to take center-stage in our programming for the public. A public debated entitled “Is the Obama Health Care Reform Constitutional?” received significant media attention, and brought together the leading constitutional law experts (Larry Tribe, Charles Fried, Randy Barnett) to debate the likely fate of the Affordable Care Act. A separate panel united advocates and analysts to examine possible changes to health care payment reform. An event with Massachusetts Senator Richard Moore discussed Massachusetts health care reform process and its outcomes to try to extract lessons applicable to federal reform program efforts underway. A panel on racial disparities brought together lawyers, doctors, and economists to examine complex issues surrounding equities in health care delivery across racial and socio-economic divides.

The Center’s public bioethics-oriented programming this year included a discussion of fetal and neonatal research and the legislation governing it, a panel on female circumcision that brought together doctors, academics, and human rights advocates, a panel on the treatment of children with disabilities, and an event focused on autism and its treatment in the psychiatric community that considered the views of advocates, scientists, psychiatrists, and lawyers. Our pharmaceutical/biotechnology programming included a session on challenges to pharmaceutical patents in the developing world, a panel discussion with leading FDA lawyers inside and outside of the agency on the regulation of biosimilars, emergency preparedness, and other current controversies in food and drug law, and a meeting with FDA Commissioner Margaret Hamburg during which students were able to ask the Commissioner questions about the most pressing issues in the field, which lead to a candid discussion about the day-to-day challenges the Agency faces to fulfill the obligations of its mandate to protect consumers, and how this mandate has evolved to grapple effectively with the rapid changes in technology that impact and augment the Agency’s responsibilities.

This report describes these accomplishments in greater detail, and briefly outlines plans for next year’s programming.

2009-2010 has been another successful year for the Center, as we further consolidated our position as the preeminent academic institution examining how law intersects with health care, bioethics, and biotechnology.

Our academic fellowship program, offering two years of support and mentorship for post- graduates, continues its remarkable record as a pipeline to top academic positions. Our outgoing fellows published highly-lauded work on the interplay between health insurance mandates and health care fragmentation and how to avoid biased experts as part of medical malpractice trials. These papers were published respectively in the American Journal of Law and Medicine and the New York University Law Review. After turning down several other offers, they ultimately accepted professor positions at the law schools at UCLA and the University of Arizona, adding to the Center’s prior placements at Harvard, UC Berkeley, and Boston University. Our current academic fellows are working on papers in topics such as reforming the Patent and Trademark Office, and the effects on medical malpractice rules on obstetrics and other medical practices.

Our student fellows continue to produce impressive work on a broad range of issues in health law, bioethics, and biotechnology. The intensive mentorship from Petrie-Flom affiliated faculty and from our academic fellows continues to pay dividends in improving the quality of these students’ work, and we are pleased to have played a part in the placement of two of our former student fellows in positions at Duke Law School and the MIT economics department.

Our founding director, Einer Elhauge, published an edited volume with Oxford University Press this year entitled The Fragmentation of U.S. Health Care: Causes and Solutions, with papers stemming from a conference the Center convened two years ago, and which is both relevant and important in plotting the course forward.

Speaking of health reform, in our programming for the public, the Center capitalized on this exciting moment in health care history. Our program included events on the relationship between being under- and uninsured and going bankrupt or experiencing home foreclosure; an address from one member of Obama’s Domestic Policy Council and Director of the Office of National AIDS Policy on the then-evolving health reform plans on HIV/AIDS and disability rights issues; and an examination of comparative models for health reform. In the pharmaceutical and biotechnology sphere we convened leading thinkers to discuss the use of medical prize funds as alternative rewards for medical innovation; and the then-pending legislation on intellectual property protection for follow- on biologics. Our bioethics oriented programming included events on the new politics surrounding regulation of stem cell research, and how developments in neuroscience and evolutionary biology should impact our thinking about law and morality.

We also held four important closed-door events. The first brought together economists, philosophers, lawyers, and policy-makers to develop consensus on an appropriate set of metrics and tools for evaluating the impact of innovation on global health. The second focused on best practices and emerging legal and ethical issues in conducting multi- regional clinical trials and gathered high-level executives from the major pharmaceutical and biotech firms, academics from schools including Harvard, Duke, Toronto, Tufts, Penn, Johns Hopkins, foreign experts from Brazil, India, Malawi, the U.K., and the Czech Republic, and representatives of many government and private-public partnerships, including the National Institutes of Health and the Gates Foundation. The third event was a training program for approximately 40 federal judges to learn about the most recent research in neuroscience and what impacts they may or may not have on the legal cases they see in their courtrooms. Finally, our annual conference, this year entitled Moral Biology?? What (if anything) Can Advances in the Mind Sciences and Evolutionary Biology Tell Us about the Law and Morality, brought together a prestigious group of leading scholars in law, psychology, neurology, evolutionary biology, economics, and philosophy to discuss what implications developments in the mind sciences and evolutionary biology should have on moral and legal analysis of responsibility, punishment, addiction, cooperation, and racism

This report describes these accomplishments in greater detail, and briefly outlines plans for next year’s programming.

The 2008-2009 academic year marked the third year of the Petrie-Flom Center. Under the leadership of Visiting Faculty Director, Anup Malani, the Center’s curricular and public events programming brought together a highly diverse group of students, scholars and practitioners in the fields of health law, health policy, bioethics and biotechnology to further the Center’s mission of generating quality research in these rapidly changing fields.

Given the potentially dramatic changes to these fields with the 2008 presidential elections, this year’s programming addressed a wide array of pressing health care topics. The Center’s public events tackled issues ranging from the role of dignity in medical decision making, to the competing healthcare reform proposals of the 2008 presidential candidates. The year culminated with a conference on the legal and economic challenges to research and development in the pharmaceutical industry. All of the Center’s events featured participation from nationally-recognized scholars and prominent industry practitioners, as well as enthusiastic participation from members of the Law School and greater Harvard University community.

The centerpieces of the Center’s curricular activities were the Health Law Policy Workshop and the first annual Colloquium of Student Research in Health Law. Responding to increasing interest from faculty and students across the University, Prof. Malani convened the Health Law Policy Workshop weekly for two semesters (rather than just one). Researchers from a wide variety of disciplines were invited to present their findings to an audience of peers and students from across Harvard University. The cross-disciplinary nature demonstrated the many different approaches scholars employ to grapple with the complex problems of our healthcare system. The Student Colloquium likewise received an enthusiastic response. This one day conference showcased health law research papers by a dozen students from across Harvard University. Students who presented their research gained valuable experience presenting their findings, and important feedback from faculty and fellows of the Center. Our hope is that the large audience of students was inspired to pursue their own research projects and present them at next year’s Colloquium.

Finally, with respect to our aim of developing new law and policy scholars specializing health law, the Center extended its track record of successful placements. Our Academic Fellows on the entry-level law professors’ market landed tenure track positions at the University of California Berkeley’s Boalt Law School and at the Boston University Law School. The Center continued to address the demand for health scholarship from existing professors. A greater number of Law School professors applied for and received grants to conduct summer research, and they represented specialists from a wider variety of fields of specialty than ever before, including bankruptcy, torts, patent law, and disability law.

This report describes these accomplishments in greater detail.

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics is pleased to submit the report of activities 2007-2008 academic year. This year has seen the completion of our first full cycle of the Academic Fellowship Program and witnessed astounding accomplishments not only in this initiative, but across the full range of our activities. The appointment to the Harvard Law School faculty of the only two Petrie-Flom Academic Fellows on the entry-level law professor’s job market, Glenn Cohen and Benjamin Roin has been the dramatic highlight of the year’s successes. Our primary focus has been on using the academic fellowship program to develop a new generation of schol ars interested in issues of health law policy, biotechnology and bioethics. Indeed, we expect that the scholars, affiliates and partners of the Center will contribute to the legacy of our programs for many years to come, as their careers grow and th ey are asked to lead the nation with their expert insights on a field that needs serious consideration. With the current and predicted growth and changes to healthcare facing our soci ety, the Center’s role will only increase in importance and prominence in the coming decades. Already the Center has served as a model for the foundi ng of similar centers at Georgetown and other law schools, and we were recently approached by a Ko rean university seeking a model for how to organize its own center.

We also have considerable su ccess to report with respect to our goals to elevate the level of rigorous scholarship in health la w. Our workshop continues to offer a forum for rigorous analysis of cutting-edge schol arship, and has connected leading scholars at all of Harvard’s major health centered schools and other universities from across the country. Many of the works presented at those sessions have been published in journals such as the New England Journa l of Medicine and the Georgetown and Michigan Law Reviews. Also we have accomplished the goal of promoting high- level scholarship by inducing existing Harvard faculty to use their expertise to focus on long-neglected issues fall ing with the Center’s ma ndate. Our senior fellow, Professor Frances Kamm, one of the world’ s leading philosophers, has spent the year writing a book on bioethics, a nd providing invaluable mentorship to our fellows. Since the establishment of the Petrie-Flom Center, the faculty summer grants program has helped induce many Harvard Law Sc hool faculty members to write new, important research in the long unaddressed issues related to health and law. This year we have had an unprecedented eight applic ations for these grants, a remarkable transformation from before the Center existed.

Increasingly, students are engaging with the Center through our programmatic and curricular initiatives with enthusiasm and a level of academic maturity that is unparalleled by other specialized areas of instruction at the Law School. Recently, the Center hosted an open house for stude nts admitted to Harvard Law School who were visiting to decide whethe r to matriculate. As a resu lt of their interactions with our fellows and faculty, several students being courted by other leading law schools made the decision to attend Harvard. Add itionally, this year’s class of student fellows produced exceptionally sophisticated scholarship in their independent writing projects. We expect many of them will continue their pursuit of health law and perhaps be future candidates for post- graduate fellowships at the Center.

The involvement of these constituents in the Center’s work, in addition to the participation of broad communities of indivi duals interested in our work through our events and conference programming describe d in further detail below, helps the Center enjoy a well regarded and firmly es tablished reputation as one of the nation’s leading institutions for the development a nd discourse of legal, policy and ethical issues related to h ealthcare and society.

We are enthusiastic to submit this report chronicling the Petrie-Flom Center’s first operational year of activities. While we will not be at full staffing until the rest of our crew of fellows join in September, the many achievements the Center has experienced thus far are widespread, and excitement about our mission is palpable. The Center has attracted attention at Harvard and beyond, engaging leading intellectuals from all across the country in fields at the intersection of health and law. Through the Center’s variety of programs and initiatives, we have demonstrated significant success toward our mission to foster the development of a new generation of promising scholars who will play a key role in defining the growth of the field of health law.

The most notable and exciting advances of the Center’s first year have been those made in our research and fellowship programs. The Center has succeeded in developing, fostering, and establishing a home to a community of the finest scholars dedicated to research in the fields of health law. Without the support from the Center, many of its affiliated scholars would not have focused their work on issues of health law policy and bioethics as much as they have. These programs have thus been very successful in achieving its goal of getting top minds to focus on this field, where they otherwise might not have.

By definition, the nature of the Center’s work is interdisciplinary and cuts across traditional academic disciplines, engaging the attention of scholars and practitioners to explore and define the complex challenges at the intersection of health and law. Driven by the Center’s programmatic component and participation in activities undertaken in collaboration with a number of Harvard University programs and student groups, we have established strong links to programs and individuals throughout the university. The interdisciplinary nature of the fields addressed by the Center’s core initiatives necessitates strong links and wide reaching collaboration with colleagues in various fields from within Harvard Law School and from across the University. The workshop, conferences and events program in this first year has helped to establish the Center as a local hub of intellectual debate and a source of information about critical issues concerning health law, policy, biotechnology and ethics. We expect that our future programming will continue to serve this role, and will expand to draw even wider national attention to the Center’s leading role as a forum for non-partisan, intellectual debate about these issues.

This report chronicles the first year of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School. The final months of the Petrie-Flom Center’s start-up year were highlighted by our move into new offices and the arrival of our first post-graduate fellows. We enter 2006-07 poised to begin the first real year of programming and operations that will mark the next phase of our development.https://petrieflom.law.harvard.edu/wp-content/uploads/2024/11/pfcannualreport06.pdf