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Executive Summary

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.