Abstract
AbstractSince 1978 and the initial French data protection law (Loi n°78-17 du 6 Janvier 1978), consecutive modifications regarding the protection of personal health data, especially in 2004, 2016 and 2018, set up a strict legal regime for processing sensitive personal data, including for research purposes. In recent years, French law has evolved proactively and in parallel with the work of the European Union (EU) on the preparation of what became the General Data Protection Regulation (GDPR), which has been in force since May 2018. This Chapter performs a state-of-art analysis (as of 1 July 2019) of the French legal framework for research biobanks and data protection rules applying to biobanking, in particular those related to data subjects’ rights and Article 89 of the GDPR. Firstly, it provides updated information about the national landscape of active research biobanks in France (Sect. 1). Secondly, it explores how the French law embodies the developments brought by the GDPR and how it envisages individuals’ rights in the context of research biobanking (Sects. 2 and 3). Thirdly, this Chapter analyses existing and potential national exemptions to individuals’ rights, including with regard to Article 89 GDPR, and how France conceives of processing activities of ‘public interest’ (Sect. 4). Finally, the authors address ongoing debates around bioethics law in France and argue for the creation of a specific Act focused on biobanking as a means of integrating, clarifying and developing not only data protection rules but also other activities related to samples, human or not, in a unique, operational and compact act (Sect. 5).
Highlights
Chassang (*) LEASP, Inserm, Université Paul Sabatier Toulouse 3, Toulouse, FranceInfrastructure Nationale Biobanques, Institute for Public Health, Clinical Research Department, Paris, France
It explores how the French law embodies the developments brought by the General Data Protection Regulation (GDPR) and how it envisages individuals’ rights in the context of research biobanking (Sects. 2 and 3)
Since 2006, this regulatory dynamism has intensified, notably in consideration of the debates which led to the European Commission proposal to adopt a European Union (EU) General Data Protection Regulation (GDPR) in 2012 and its formal adoption in 2016
Summary
Infrastructure Nationale Biobanques, Institute for Public Health, Clinical Research Department, Paris, France. E. Rial-Sebbag Infrastructure Nationale Biobanques, Institute for Public Health, Clinical Research Department, Paris, France. Of a specific Act focused on biobanking as a means of integrating, clarifying and developing data protection rules and other activities related to samples, human or not, in a unique, operational and compact act Of a specific Act focused on biobanking as a means of integrating, clarifying and developing data protection rules and other activities related to samples, human or not, in a unique, operational and compact act (Sect. 5)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
