[Chapter 4. Governing Big Data for Health, national and international issues]

The use of health data is increasingly seen as a central issue for research and also for care. The generation of these data is an added value for the conduct of large-scale studies, it is even considered as an (r) evolution in the methodology of research or even for personalized medicine. Several factors have influenced the acceleration in the use of health data (advances in genetics, technology and diversification of sources) leading to a re-questioning of the legal principles for the protection of health data in both French law and European law. Indeed, first, the massive production of data (Big Data) in the field of health affects the quantity and the quality of the data which consequently reconfigure the tools of protection of private life and on the informational risk. Second, the use of these data is based on existing fundamental principles while raising new challenges for their governance.