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Executive Summary

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:

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