Source: Leaders League(more…)
European Data Protection Board Clarifies the Interplay Between the EU Clinical Trials Regulation and the General Data Protection RegulationApril 8th, 2019 | Posted by in eHealth | Guidelines | Privacy - (0 Comments)
On January 23, 2019, the EU Data Protection Board (“EDPB” – the gathering of all European Union (EU) data protection authorities) adopted opinion no. 3/2019 (the “Opinion”) on the interplay between the Clinical Trials Regulation no. 536/2014 “CTR”) and the General Data Protection Regulation (“GDPR”). Anticipating the application of CTR (currently expected to occur in 2020) following the implementation of the EU portal and the EU database of the European Medicines Agency, the Opinion provides clarification on (i) the different legal bases for the processing of personal data operations related to a specific clinical trial, from commencement of the clinical trial until the deletion of personal data collected during the clinical trial (“Primary Use”); and (ii) the further use of the same personal data set for any other scientific purposes (“Secondary Use”). Without establishing a legal basis, no one can process the personal data needed to run a clinical trial or to use the personal data for other research.