GDPR and Biobanking

Santa Slokenberga holds a LL.D. in Medical Law and is a researcher at Uppsala University in Sweden. Her research focuses on legal issues genetics, with a particular emphasis on the protection of personal data. Her other research interests include regulating the standards of medical care and scientific uncertainty. In 2016, she defended her doctoral thesis entitled “European Legal Perspectives on Health-Related Direct-to-Consumer Genetic Testing”. Since then, she has participated in two European research projects that relate to biobanking and data protection, B3Africa and SIENNA, carried out a postdoctoral research at Lund University in Sweden and has served as an ELSI expert at BBMRI-ERIC CS ELSI.Olga Tzortzatou holds a LL.D. in Theory of Law on the protection of health data in the field of biomedical research from the National Kapodistrian University of Athens. As from 2008 she is an in house lawyer at the Biomedical Research Foundation of the Academy of Athens. She is also a member of the Bioethics Committee of BRFAA and an external ethics screener for the European Commission Research Executive Agency. Since 2015 she serves as an ELSI expert at BBMRI-ERIC CS ELSI.Jane Reichel is a professor in Administrative Law at the Faculty of Law at Stockholm University and is since 2011 tied part-time to Center of Research Ethics & Bioethics at Uppsala University. She defended her thesis in European Administrative Law at Stockholm University in 2006. Between 2009 and 2018 she worked at the Faculty of Law in Uppsala University. She has participated in several European research projects on biobanking and data protection, for example BioBankCloud and B3Africa.

• Part I Setting the scene.- Introduction: Individual rights, the public interest and biobank research 4000 (8).- Genetic data and privacy protection.- Part II GDPR and European responses.- Biobank governance and the impact of the GDPR on the regulation of biobank research.- Controller’ and processor’s responsibilities in biobank research under GDPR.- Individual rights in biobank research under GDPR.- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research.- A Pan-European analysis of Article 89 implementation and national biobank research regulations.- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations.- Part III National insights in biobank regulatory frameworks.- Selected 10-15 countries for reports: Germany.- Greece.- France.- Finland.- Sweden.- United Kingdom.-  Part IV Conclusions.- Reflections on individualrights, the public interest and biobank research, ramifications and ways forward.