Health research, protection of personal data and General Data Protection Regulation

France has a very rich legal framework, which defines the conditions of access and use of health data for scientific research purposes and ensures their protection. Currently, this legal framework is undergoing revision. The European regulation of April 27th 2016 on protection of natural persons in relation to the processing of personal data came into effect in EU member states since 25th May 2018 and substitute a rationale of administrative process for a rationale that empowers the researchers to document and prove compliance with the regulation ("accountability"). This regulation must be coordinated with the other regulation applicable to research in UE and with national law. (C) 2018 Published by Elsevier Masson SAS.