European Health Data Space – RWE Put to Work for Public Health

Speaker(s)

Steffen Thirstrup, MD, PhD, CMO1, Petra Wilson, PhD2, Markus Kalliola, MSc, MSocSc3, Andrzej Rys, MSc4, Patrice Verpillat, MD, MPH, PhD1 and Trine Pilgaard, MSc5, (1)European Medicines Agency, Amsterdam, Netherlands(2)Health Connect Partners, FTI Consulting, Brussels, Belgium(3)The Finnish Innovation Fund Sitra, Helsinki, Finland(4)European Commission, Brussels, Belgium(5)Pfizer, Ballerup, 84, Denmark

Establishing a European Health Data Space (EHDS) giving citizens easy access to their own health care records also holds a potential for RWE generations via secondary use of such data. The session will explore the political vision and realities of EHDS including discussion and challenges related to any opt-in or opt-out options. We will hear patients’ views both regarding the utility of an EHDS as well as issues related to data privacy. Pathfinder projects like Towards European Health Data Space, TEHDAS, will shed light on the challenges with bringing numerous and often diverse data sources together on one platform, and the European Medicines Agency will present their vision and concrete examples of RWE in the regulatory decision-making process.

Code

100

Topic

Real World Data & Information Systems