By Stéphanie De Smedt

Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating the processing of health data, international data transfers and contractual arrangements between the parties involved in a clinical trial, the GDPR has had quite an impact in the life sciences sector.

In the context of clinical trials, the GDPR has particular relevance, not only for European hospitals or EU-based sponsors of such clinical trials, but also for non-European entities when they fall within the (extra-) territorial scope of application of the GDPR.