Governing Health 4.0: Legal and Ethical Considerations – US-European Perspectives

Health 4.0 comes with a lot of promise, as advanced machine learning and Big Data are posed to transform the health & life sciences with the emergence of AI- and data-driven healthcare systems. However, as with any promising innovation, great expectations are oftentimes accompanied by an equivalent amount of disruption. In a healthcare context, this translates particularly into legal and ethical concerns on patient privacy and rights, the economic value of health-related data, and liability. 

States have a great role to play in governing and regulating the development of Health 4.0. In the last two years, several reports analyzing the state of the art of the policy options have been issued in the U.S. and in Denmark. These two countries have radically different healthcare systems, both in terms of their underlying values and their functioning. This seminar, organized by the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), aims at understanding how the U.S. and Denmark tackle the challenges brought by emerging healthcare technologies and shape in their own way a data-driven healthcare system. 

Five international scholars from a multidisciplinary background will share their insights and debate on this topic:

    • Timo Minssen, Professor & Director, Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen
    • Glenn Cohen, Professor & Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School
    • Sara Gerke, Research Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School
    • Mette Hartlev, Professor & Director of the Centre for Legal Studies in Welfare and Market at the University of Copenhagen
    • Andreas Panagopoulos, Assistant Professor, University of Crete

Snacks and refreshments will be provided. 

This event fulfills the requirements of the Danish Bar and Law Society for continuing legal education. Please tick the relevant box in the registration form if you wish to receive a certificate for the whole event (issued in Danish only).

Conference program




9:00 - 09:20

Pr. Timo Minssen

Welcome & Introduction: AI, Big Data & Machine Learning in the Health & Life Sciences: Recent Danish initiatives and why law matters 

9:20 – 09:45

Pr. Glenn Cohen

Liability for Medical AI in the U.S.

09:45 – 10:10

Sara Gerke

AI and Big Data – Data Protection and Privacy in the US and the EU

10:10 – 10:30



10:30 – 10:55

Pr. Mette Hartlev

Big Data, personalized medicine and tensions between autonomy and solidarity in the Danish welfare state

10:55 – 11:20

Andreas Panagopoulos
Appropriating the Value of User-Generated Data in the AI Era; From Commons to Data-Managers

 11:20 – 11:45

Panel debate and Q&A session



Please register no later than 08:00 27 May 2019 using this registration form.


This event is organized by the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL).

Very special thanks go to the CeBIL student assistants Irene Ottolini, Dimitrios Svolis and Bénédicte Illien for their hard work in setting up this event.

About CeBIL

The Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) is an international research center exploring legal challenges and rapid developments in biomedical innovation in DK and around the Globe. Based at the University of Copenhagen’s Faculty of Law, the Centre brings together some of the world’s leading research institutions in interdisciplinary collaboration, including Harvard Law School, Harvard Medical School/MIT and the Universities of Cambridge and Michigan. It also engages a broad variety of stakeholders from industry, government and civil society. The overall aim and ambition of CeBIL is 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 cross-disciplinary perspective. A major research focus of CeBIL is the use of artificial intelligence and digital disruption in biomedical innovation, see e.g.

Presentation of the speakers and abstracts (pdf).