Legal Issues Arising from AI and Big Data in the Health and Life Sciences – University of Copenhagen

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Legal Issues Arising from AI and Big Data in the Health and Life Sciences

Artificial intelligence, advanced machine learning and Big Data will transform the health & life sciences. While offering amazing possibilities, there is no doubt that these technologies raise many legal questions with regard to IP, liability, patient involvement, bias, discrimination, competition etc. They will also disrupt traditional value chains and structures in the health care sector.

How do we regulate intermediate technology? Most innovation policy levers are not set up to consider whether intermediate technologies ought to be regulated differently than technologies which are further along in the development process.   What is the role of industry in the innovation ecosystem and how does that fit in the European Science Cloud Declaration (EOSC)?  How does the Nuremberg Code help us address the opportunities and challenges we face with the application of AI and Big Data in the health and life science sector?

This seminar features a distinguished list of prominent international speakers that will debate some of the most crucial legal challenges arising from these issues.


15:00 – 15:10  Welcome note by Prof. Timo Minssen, CeBIL: "Legal challenges posed by AI & Big Data in the Health & Life Science"
15:10 – 15:45 Iain G. Mitchell QC, Tanfield Chambers: “Robot Doctors? - Some
Legal and Ethical Issues of Using Artificial Intelligence in Medicine”
15:45 – 16:20
Dr. Rachel Sachs, Washington University School of Law:
“Regulating Intermediate Technologies”
16:20 – 16:35 Break
16:35 – 17:10 Dr. Helen Yu, CeBIL: “The European Open Science Cloud:  What
about Other Stakeholders’ Interests?”
17:10 – 17:45
Dr. Sonu Bhaskar, Liverpool Hospital (Sydney): "The Elephant in the Room: Revisiting the Nuremberg Code to Address Emerging Opportunities and Challenges with the Uptake of AI and Big Data in Health and Medicine"
17:45 – 18.00
Dr. Sven Bostyn: Final Remarks
18:00 – 18:30
Closing and drinks


Please register no later than the 5th of October at 12:00 using this registration form.

This event fulfils the requirement of the Danish Bar Association for continuing legal education (Regler om løbende obligatorisk efteruddannelse for advokater og advokatfuldmægtig). Please tick the relevant box in the registration form if you wish to receive a certificate for the whole event (exceeding 2h15).

About the speakers:

Abstracts for Legal Issues Arising from AI and Big Data in the Health and Life Sciences (pdf)

Iain G. Mitchell QC 
Iain G. Mitchell QC FRSA is a member of both the Scottish and English Bars, having been called to the Scottish Bar in 1976 and having taken silk in 1992. He was called to the English bar in 2012.

His wide civil practice extends to courts at all levels in both jurisdictions, with over 60 reported cases in Scotland alone. He is ranked in the Chambers Directory for IT Law, IP Law and Public Procurement, and is ranked in the Legal 500 for Commercial Litigation and Intellectual Property, Information Technology and Media IT and IP Law. He is the Chair of the CCBE Working Party on Surveillance. He is also a member of the UK delegation to the CCBE and UK representative on the IT Committee of the CCBE. He is a member of the IT Panel of the Bar Council of England & Wales and serves on its working party on the General Data Protection regulation. He is Chairman of the Scottish Society for Computers and Law and an honorary lecturer at the Institut für Informations- Telekommunikations- und Medienrecht at the Wilhelms-Universität, Münster, Westphalia, as well as being a Liveryman of the Worshipful Company of Information Technologists.

He is Joint Editor of the International Free and Open Source Law Review. His publications include contributions to Electronic Evidence (Butterworths), The Open Source Law Book (Open Source Press), Free and Open Source Software: Policy, Law and Practice (Oxford University Press) and Innovation and Future of the Legal Profession in Europe (Bruylant, Brussels), as well as frequent contributions to professional journals and general journalism.

Dr. Rachel Sachs
Professor Rachel Sachs is a scholar of innovation policy whose work explores the interaction of intellectual property law, food and drug regulation, and health law. Professor Sachs’ scholarship has or will have appeared in journals including the Michigan Law Review, the Harvard Law Review, the New England Journal of Medicine, and the Journal of the American Medical Association. Prior to joining Washington University, Professor Sachs was an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and a Lecturer in Law at Harvard Law School. She also clerked for the Honorable Richard A. Posner of the U.S. Court of Appeals for the Seventh Circuit. She received her J.D. magna cum laude from Harvard Law School and a Master of Public Health from the Harvard School of Public Health. She received her A.B. in Bioethics from Princeton University.

Dr. Helen Yu
Helen Yu is an Assistant Professor and Associate Director of the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen, Faculty of Law. Her research focus is in exploring how existing intellectual property and policy tools can be leveraged to improve and proactively support the transformation of biomedical research and innovation into socially and economically beneficial outcomes.  In this context, she adopts an interdisciplinary approach to studying how technology, open innovation, business models, public private partnerships, and the law can inform the development of an innovation platform that is responsive and reflective to the interests of stakeholders involved in the innovation ecosystem.  Helen holds a degree in neuroscience from the University of British Columbia, a Juris Doctor from Queen’s University and practiced as an intellectual property lawyer for 8 years before obtaining her PhD at the University of Copenhagen.  Helen is a Registered Patent and Trademark Agent with extensive European and North American experience.

Dr. Sonu Bhaskar
Dr Sonu Bhaskar is a clinician scientist, academic neurologist, and an innovator based in Sydney, Australia. He is the Team Lead of Neurovascular Imaging and Translational Neuroengineering Laboratory and Neurovascular Fellow in Stroke and Neurology at Liverpool Hospital and Ingham Institute for Applied Medical Research. He holds conjoint appointments with Western Sydney University, the University of Newcastle and John Hunter Hospital in Australia. He is the founding member and Chief Investigator of Australia’s first New South Wales Brain Clot Bank and Thrombolysis and Endovascular FLow Network (TEFLON) trial. He has been the recipient of prestigious international awards for his translational focus including South West Sydney Health Beyond Translation award, EU Marie Curie fellowship, Spanish Ministry of Health fellowship, Dutch Ministry Top Talent Award in Biomedical Sciences and Medical Innovation, and Prof AR Rao Young Scientist Award. Dr Bhaskar's work has been published in several journals including Nature Scientific Reports, Annals of Clinical and Translational Neurology, BMC Neurology, Neuroepidemiology and Journal of Cerebral Blood Flow and Metabolism. Dr Bhaskar is on a mission to reduce the global burden of neurological diseases in general and stroke, in particular, intending to bring translational change in clinical practice with cutting-edge bed-tobedside innovation and research.

Prof. Timo Minssen
Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founding Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). His research concentrates on Intellectual Property-, Competition & Regulatory Law with a special focus on new technologies in the pharma, life science & biotech sectors. This involves a plethora of legal issues emerging during the lifecycle of biotechnological and medical products and processes - from the regulation of research and incentives for innovation to technology transfer and commercialization. Timo is presenting frequently on a wide variety of pressing topics at international IP symposia, major law firms, the Universities of Oxford & Cambridge, Harvard Law School, MIT, and at the European Medicines Agency etc.. He has written 2 books and published 80+ articles and book chapters in leading international publications, such as Nature Biotech, PLoS-Computational Biology, Biotech. J., BLR, Person.Med., IIC, EIPR, ECLR, JIPLP, GRUR Int., Chi.-Kent J. Intell. Prop., IPQ, QMJIP, ERT, NIR & EUConst.LR. He is also a regular contributor on Harvard Law School's "Bill of Health" blog. Prior to founding CeBIL, Timo headed CIIR's  Copenhagen Biotech & Pharma Forum (CBPF).

Dr. Sven Bostyn
Dr. Sven Bostyn is an Associate Professor of law the University of Copenhagen. He also lectures at the Institute for Information Law (IVIR) of the University of Amsterdam and is Visiting Professor (chargé de cours invité) at the Université de Liège. He is also a regular lecturer on CEIPI courses in Strasbourg. Sven is one of the most prominent authorities in Europe in the area of patent law in general and in life sciences (including patent law relating to pharmaceuticals, biotech, medical devices, SPC’s, software and artificial intelligence) in particular. He has written extensively (more than 60 single authored scientific publications) on most areas of patent law, and apart from those subjects already mentioned, he has also published in the field of plant patent protection, plant variety rights, software related inventions, European and international harmonization of patent law and the Unitary Patent system.

He was from 2013-2016 the Chair of the Expert Committee at the European Commission on the development and implications of patent law in the field of biotechnology and genetic engineering, after having been a member of and Rapporteur at an earlier European Commission Expert Group (between 2003 and 2005). Besides the European Commission, he has also advised both the Belgian and Dutch governments on policy regarding patentability of biotechnological and pharmaceutical inventions. He was recently one of the lead researchers in a study commissioned by the Dutch ministries of Health and Economic Affairs and Climate regarding protection mechanisms for pharmaceuticals (SPC’s, data and market exclusivity, paediatric extensions, orphan drug designations and competition law issues relating to pharmaceuticals)