The International Regulators’ Roundtable on Artificial Intelligence Technologies in Health Care

This is a past event

Notice of Cancelation

In light of developments with COVID-19, we have made the decision to cancel the International Regulators’ Roundtable on Artificial Intelligence Technologies in Health Care.

Conference Description

Join us as we bring together federal-level government regulators of artificial intelligence technologies in North American, European, and Asian jurisdictions to highlight efforts around the globe to appropriately regulate the use of artificial intelligence (AI) technologies in health care. The assembled regulators will discuss their initiatives in this area along with the challenges of regulating this unique and rapidly developing field. Uniquely among AI-focused events, this conference will concentrate on the hurdles to implementing effective regulation of these new technologies and to consider the role of government regulators in shaping the evolution of AI in health care.

Interdisciplinary panels of regulators, legal scholars, regulatory science experts, physicians, and AI developers will articulate the challenges and opportunities in this space. These panels will foster cross-disciplinary discussion and improve public understanding of the state of AI implementation in health care, including highlighting regulatory leaders.

Agenda

8:30 – 9:00am, Registration

9:00 – 9:15am, Introductions

  • I. Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
  • Timo Minssen, Professor of Law and Director, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen and Researcher in Quantum Law, Lund University
  • Elazer Edelman, Edward J. Poitras Professor in Medical Engineering and Science, MIT; Professor of Medicine, Harvard Medical School; and Senior Attending Physician, coronary care unit, Brigham and Women’s Hospital

9:15 – 9:30am, Welcome Remarks

  • John Manning, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

9:30 – 10:00am, Keynote

  • Karl Broich, President, Federal Institute for Drugs and Medical Devices (Germany)

10:00 – 11:00am, Panel 1: The Potential, Promise, and Pitfalls of Health AI

  • Nikolai Brun, Director of Division, Medical Evaluation & Biostatistics, Danish Medicines Agency and Chair, joint HMA-EMA Taskforce on Big Data
  • Howard Bauchner, Editor-in-Chief, JAMA and Professor of Pediatrics, Boston University School of Medicine
  • Karine Perset, Internet Economist, Organisation for Economic Co-operation and Development (OECD)
  • I. Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
  • Moderator: Barbara E. Bierer, faculty director, Multi-Regional Clinical Trials Center, Brigham and Women’s Hospital and Harvard (MRCT Center) and Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital

11:00 – 11:15am, Break

11:15am – 12:15pm, Panel 2: Legal Considerations in Regulating Health AI

  • Talia Agmon, Deputy Chief Legal Counsel, Ministry of Health, Israel
  • Sara Gerke, Research Fellow, Medicine, Artificial Intelligence, and Law, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
  • Nicolas Terry, Hall Render Professor of Law and Executive Director, Hall Center for Law and Health, Indiana University Robert H. McKinney School of Law
  • Rolf Gertsch, Head, Legal Division Medicines and Deputy Head, Legal Sector, SwissMedic / Swiss Agency for Therapeutic Products
  • Moderator: Nicholson Price, Professor of Law, University of Michigan School of Law

12:15 – 12:45pm, Keynote

  • Bakul Patel, Director, Division of Digital Health, FDA (USA)

12:45 – 1:15pm, Lunch

1:15 – 2:30pm, Panel 3: Is AI Different Than Other New Technologies?

2:30 – 3:30pm, Panel 4: Good Governance of Health AI

  • J. Satyanarayana, Chairman of the Committee, National Digital Health Blueprint (NDHB) design, Federal Government of India (2018 – 2019); Chairman, Unique Identification Authority of India (2016 – 2019); Secretary, IT of the Federal Government (2012 – 2014)
  • Alessandro Mantelero, Associate Professor of Private Law, Polytechnic University of Turin (Politecnico di Torino) and Council of Europe Scientific Expert on Artificial Intelligence and data protection
  • Mojisola Christianah Adeyeye, Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) (Nigeria)
  • Sandra Wachter, Associate Professor and Senior Research Fellow in Law and Ethics of AI, Big Data, Robotics and Internet Regulation, Oxford Internet Institute (OII), University of Oxford (UK) and Visiting Professor, Harvard Law School
  • Moderator: Jacob S. Sherkow, Edmond J. Safra Center and Petrie-Flom Center Fellow in Ethics of Technological and Biomedical Innovation; Professor of Law, Innovation Center for Law and Technology, New York Law School; Permanent Visiting Professor, Center for Advanced Studies in Biomedical Innovation Law, University of Copenhagen Faculty of Law

3:30 – 3:45pm, Break

3:45 – 4:45pm, Panel 5: Challenges and Opportunities of Regulating AI

  • Richard Branson, Devices Division, Medicines & Healthcare products Regulatory Agency (MHRA) (UK)
  • Philippe Girard, Deputy Executive Director, Head of Licensing Sector, Swissmedic, Swiss Agency for Therapeutic Products
  • Timo Minssen, Professor of Law and Director, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen and Researcher in Quantum Law, Lund University
  • Nathan Cortez, Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies, Southern Methodist University Dedman School of Law
  • Moderator: Carmel Shachar, Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Centre for Advanced Studies in Biomedical Innovation Law at University of Copenhagen, with support from the Jorcks Foundation Research Prize, and the Massachusetts Institute of Technology Institute for Medical Engineering and Science.

Part of the Precision Medicine, Artificial Intelligence, and the Law Project at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, which is supported by a Novo Nordisk Foundation-grant for a Collaborative Research Programme (grant agreement number NNF17SA0027784).