CeBIL Seminar on Legal Aspects of Medical AI and Precision Medicine – University of Copenhagen

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CeBIL Seminar on Legal Aspects of Medical AI and Precision Medicine

Two prominent international experts and CeBIL partners speak on crucial legal issues in medical AI and precision medicine. 

This CeBIL Seminar is part of the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL) launched in early 2018 by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and CeBIL. PMAIL will provide a comparative analysis of the law and ethics of black-box precision medicine, explaining the shortcomings of the current innovation policy landscape in the US and Europe, and providing a comprehensive examination of various policy options to better harness the potential of black-box precision medicine.​


16:00 – 16:15 Timo Minssen – Welcome and introduction to Legal Aspects of Medical AI and Precision Medicine: Much ado about something!
16:15 – 16:45 Nicholson Price – Medical AI, Context, and Bias

Artificial intelligence is poised to transform medical practice. Machine learning and newly available big data allow algorithms to identify cancerous skin lesions as well as skilled dermatologists. AI can quantify trauma victims’ risk of catastrophic hemorrhage as well as trained trauma nurses, and pick out the signs of diabetic retinopathy as well as expert ophthalmologists. This represents tremendous progress but also serious challenges.

 While technology developers, medical journal editors, and indeed law professors often have access to skilled dermatologists, trained trauma nurses, and expert ophthalmologists, but this access is far from typical.

For most people throughout the world, a more realistic comparison might ask how the new technology fares relative to a general practitioner, a physician’s assistant, or indeed no doctor at all. In fact, training algorithms to recommend treatments that work in world-class hospitals may often mean that those algorithms don’t recommend appropriate—or cost-effective—treatments in less elite settings.

Nevertheless, law and technology push developers to train algorithms in high-resource settings and then to evaluate algorithms against experts. This project explores how training and judging algorithms in high-resource, expert contexts creates lasting, hidden biases when those algorithms are applied in low-resource contexts, creating problems in medical care for those who need it most.

16:45 – 17:00
17:00 – 17:30 Sven Bostyn – Incentivising drug development in an era of personalized medicine. What has gone wrong and is there anything that we can do about it?

Drug development has traditionally been incentivised by patent protection and more recently also by regulatory exclusivities such as data and market exclusivity and orphan drug protection. One of the aims of this project is to evaluate what, if anything, has gone wrong with the use of these “stimuli” and whether there is anything that we can do about it, and if so what. I can assure the audience that I will not present the answers during the seminar, but I hope to provoke a fruitful discussion.

17:30 – 18:00 Q&A, Discussion and mingle


For participation in the seminar, please use this registration form no later than 21 June 2018, 09:00.

About the speakers

Nicholson Price is an Assistant Professor of Law at the University of Michigan and a CeBIL core- partner.

He teaches and writes in the areas of intellectual property, health law, and regulation, particularly focusing on the law surrounding innovation in the life sciences. He was previously an assistant professor of law at the University of New Hampshire School of Law, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and a visiting scholar at the University of California, Hastings College of the Law. He received a JD and a PhD in biological sciences from Columbia University and an AB in biological sciences from Harvard College.

Sven Bostyn (LLB, LL.M law; PhD law) is Senior Lecturer in Intellectual Property Law at the University of Liverpool. 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).