There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds with a clinical trial sponsor’s desire not to interact directly with participants or know who they are because the sponsor only gets coded data from investigators or because the study is blinded. The European Commission has recognized the need for clarifications, and is preparing a Q&A on the interplay between the GDPR and Clinical Trials Regulation 536/2014 (CTR). Prior to releasing its Q&A (which has not yet been made public), the Commission has requested the European Data Protection Board (EDPB) to advise on the Q&A. The EDPB issued its opinion in that respect on January 23, 2019.
Ronan Tigner’s practice focuses on technology matters, with a particular focus on privacy and data security and covers a broad range of both contentious and non-contentious work, ranging from regulatory dealings, litigation, and negotiations, to compliance and counselling. Mr. Tigner assists clients in a wide array of data protection matters, such as preparing and handling regulatory investigations and negotiating agreements that involve the processing of More ›
Miriam H. Wugmeister
Few lawyers in the world have Miriam’s breadth and understanding of privacy and data security laws, obligations, and practices. Co-chair of Morrison & Foerster’s preeminent Global Privacy and Data Security Group and ranked among the top in the profession by all major directories, Miriam is regularly called upon by some of the world’s largest and most complex multinational organizations to confront their most difficult More ›