How the new European data protection regulation affects clinical research and recommendations?

• Published in: Therapie Vol. 74; no. 1; p. 31
• Main Authors: Demotes-Mainard, Jacques, Cornu, Catherine, Guérin, Aurélie
• Format: Journal Article
• Language: English
• Published: France 01.02.2019
• Subjects: Big Data; Biomedical Research - ethics; Biomedical Research - legislation & jurisprudence; Biomedical Research - trends; Computer Security - ethics; Computer Security - legislation & jurisprudence; Databases, Factual; Europe; France; Humans; Information Dissemination; International Cooperation; France; Europe; Clinical research; French data protection authority; Big data; Regulatory texts; Data protection

Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulat...