The Petrie-Flom Center Launches New Project image

Petrie-Flom Center, January 23, 2018


Learn More about the Project!

The Project on Precision Medicine, Artificial Intelligence, and the Law will seek to better understand the frontiers of big data in health care diagnostics, through interdisciplinary analysis of important health law and policy issues.

January 23, 2018 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen today announced a new collaboration, the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL).

Black-box precision medicine is an exciting new frontier in health care diagnostics, harnessing the power of big data. In black-box medicine, machine-learning algorithms and artificial intelligence examine newly available troves of health data, including genomic sequences, patient clinical care records, and the results of diagnostic tests to make predictions and recommendations about care. An algorithm may be “black-box” either because it is based on unknowable machine-learning techniques or because the relationships it draws are too complex for explicit understanding. These algorithms, and artificial intelligence techniques more broadly, represent a point where health technology may outstrip human understanding.

PMAIL will provide a comparative analysis of the law and ethics 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 harness the potential of black-box medicine. It will be a major initiative, spanning five years of study.

“We are increasingly using very complicated algorithms and cutting edge artificial intelligence to predict and guide health care, such as recommending a certain dose of insulin to a diabetic patient. Some of these new techniques help us innovate and push the boundaries of medicine but others may be based on errors and lead to sub-optimal care,” said Professor I. Glenn Cohen. “PMAIL will seek the best legal and regulatory frameworks for harnessing the potential of these techniques while also protecting patients.”

PMAIL seeks to answer important health technology questions, such as: What exactly are—or will be—the distinguishing features and added benefits of black-box medicine in comparison to traditional personalized medicine? What are the concrete scientific and legal hurdles to the further development of black-box medicine? How does the legal framework differ in the US and Europe and could we learn from each other? How much control should patients have over how their data is used to produce personalized medicine models and the use of these models in their health care?

“We are excited to support PMAIL,” said Professor Timo Minssen, head of CeBIL. “The purpose of CeBIL is to understand the biggest legal obstacles to pharmaceutical innovation and propose solutions to these roadblocks to innovation. PMAIL will help us better understand the boundaries of health care data use as it supports innovative medical care.”

Professor Nicholson Price, a project collaborator and past Petrie-Flom Center Academic Fellow, added, “Artificial intelligence and machine learning in medicine create tremendous possibilities of transforming health care for the better—but it’s so different from traditional medical technology that we need new tools to understand how it should be developed, regulated, and deployed in care settings. PMAIL aims to tackle exactly those issues and help develop those tools.”

The Project is led by I. Glenn Cohen, Faculty Director of the Petrie-Flom Center and Professor at Harvard Law School; with support from Carmel Shachar, Executive Director of the Petrie-Flom Center; Nicholson Price, Assistant Professor of Law at University of Michigan; and Timo Minssen, Head of CeBIL and Professor of Law at the University of Copenhagen. The Petrie-Flom Center will shortly hire a fellow to assist on PMAIL.

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is a leading research program dedicated to the unbiased legal and ethical analysis of pressing questions facing health policymakers, medical professionals, patients, families, and others who influence and are influenced by the health care system. 

The Center for Advanced Studies in Biomedical Innovation Law at the University of Copenhagen hosts a collaborative research program whose purpose is to address and scrutinize the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL’s overall aim is to contribute to the translation of ground-breaking biomedical research into affordable and accessible therapies.

This research is supported by a Novo Nordisk Foundation-grant for a Collaborative Research Programme (grant agreement number NNF17SA027784).

For more information, visit the Petrie-Flom Center online or contact Executive Director Carmel Shachar, Petrie-Flom Center, Harvard Law School, 617-384-5475 /

ai bioethics carmel shachar genetics health law policy i. glenn cohen innovation international precision medicine regulation research w. nicholson price ii