Event details

Wed 27. Nov 2019
09:00 -
Amerika Plads 37
Copenhagen Ø
If you have any questions leading up to the event, feel free to reply to this email: seminar@plesner.com

Is Denmark a leading country in health data?

Registration Deadline: Fri 22. Nov 2019
Wed 27. Nov 2019


The rapid development of new health technologies creates new and exciting opportunities, which in combination with the increasing amount of health data can mean significantly better health services for benefit patients and society. But are we in Denmark ready to be a part of the journey? And how do we handle the many legal and technical challenges associated with the collection and use of health data?

The event is aimed at lawyers and anyone working in the life science industry. Feel free to invite too your colleagues or others in your network with an interest in the life science industry.


Practical Information
Breakfast will be offered from 8.30.


Registration must be made no later than 22 November 2019 by e-mail to seminar@plesner.com. Participation is free, but registration is required as there are a limited number of places.


You can use the parking basement, which is located under the Copper Tower with driveway from Dampfærgevej. Upon arrival, the car's registration number is provided at Plesner's reception.

Course certificates corresponding to 3 lessons are issued immediately after the seminar. If you want to get handed out a course certificate, please write this in connection with your registration.





Welcome by Uffe Mark Hansen, Chairman of the Board in Life Science Law DK and Head of Legal for Novartis Healthcare A/S.


Danish Industry (DI) by Mie Rasbech, Head of Health Policy. DI believes that to counteract those challenges facing the healthcare field, the healthcare system must work smarter, including with new digital healthcare solutions. Mie Rasbech will talk about where DI sees the health tech solutions of the future developed in close collaboration with the healthcare system, and how a growth team can ensure greater progress by making recommendations on how we can use health tech and AI better in Denmark.


Digital Hub by Jonas Tyle Petersen, Digital Strategic Manager. Digital Hub Denmark is a digital growth environment that cultivates digital imagination, creates competencies within data and artificial intelligence, and which via international branding gives potential Danish growth companies the opportunity to become digital frontrunners and make Denmark Europe's leading digital growth environment. Jonas Tyle Petersen will talk about how "digital" affects various industries and what it means for the life science industry.


UNEEG Medical by Torben Sandgren, CEO. UNEEG has developed the world's first health technology product for monitoring people with epilepsy. Torben Sandgreen will report on how UNEEG first went from an idea of ​​therapy innovation within diabetes to a new, epoch-making therapy innovation within epilepsy treatment. Further Torben Sandgreen will talk about the challenges of developing and obtaining CE approval for a product that is considered new and unique technology without precedent (predicate device), and about how this new technology challenges incorporated medical conventions and perhaps resistance to new technology in neurology.


Coloplast by Pernille Trøjgaard, Head of Clinical Operations. Coloplast has developed one Clinical Trial App, which is used in clinical trials when developing new ostomy products. The app is used to collect images of the skin and the products. Pernille Trøjgaard will talk about how the idea originated and was developed, and how Coloplast uses newly developed algorithms to analyze the images.


Networking break and coffee


Timo Minssen, Professor at Copenhagen University and founding director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). AI/ML and other technologies rely on computational power, which i.e. requires an effective international data transfer and cloud computing. The EU-US “Privacy Shield” Framework allows the free transfer of data to companies that are certified in the US under the EU-US Privacy Shield which has been widely used by companies in the healthcare and pharmaceutical sector. However, recent US litigation on data misuses have raised new questions and the EU-US Privacy Shield has been recently contested. Timo Minssen will talk about some of these challenges to international data transfer regimes and what it implies for Medical AI Technologies.


The Danish Medicines Agency by Thomas Wejs Møller, Section Leader, Medical Devices. Thomas Wejs Møller will focus on the special challenges that may exist for health technology companies in the CE marking process, both in accordance with the current rules and in accordance with the new regulations on medical devices. In addition, Thomas Wejs Møller will provide a status on the implementation of the regulations, including the latest news on the capacity of notified bodies, and on challenges related to Brexit.


Recapitulation by Uffe Mark Hansen