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