Data Protection in Medical Research (Language: German)

A EUR 5 million fine imposed by the French CNIL on a leading real-world-data provider is the latest reminder that data protection has become business-critical in clinical research.

Join our Coffee Break for a practical look at the questions that matter most on the ground: the line between pseudonymisation and anonymisation – and why it shapes negotiations between sponsors and sites; the allocation of roles between sponsor and site under the GDPR (processor vs. joint controllership) and why one and the same study can be classified differently across the EU; and what the Biotech Act changes not only for combined medicinal product and medical device/IVD studies, but in particular, the easing it provides with regard to study participants' consent on the processing of personal (health) date. We close with the AI-based analysis of study data and where it sits under the EU AI Act and from a privacy law perspective.