The protection of scientific, medical and health data is an important and strategic issue. Defining the nature of the data collected, its use and the recipients of the data are key issues to address.
The specificity of certain activities linked to the sector, in particular the strict regulations relating to clinical trials and product vigilance (pharmacovigilance, medical device vigilance), led the French Data Protection Authority (“CNIL” in France) to set up « methodologies » and specific documents.
The sensitivity of health data, the impact of violation of the regulation for individuals at the time of Big Data are a major stake in the era of e-health and in the context of the General Data Protection Regulations (GDPR).
We assist you, for your projects and/or your structures, in complying with the regulations on the protection of personal data, reinforced since the application of the General Data Protection Regulation (GDPR), and the modification of the French Data Protection Act (LIL), both in clinical research, and for health data hosting (French HDS) or health data warehouses (French EDS).
We assist you in the analysis of the regulations and provide you with our expertise to implement pragmatic and operational solutions.
The firm is a member of the AFCDP (French data protection officer association) and participates in working groups, particularly on health data.
Among our expertise:
- Audits, inventory of compliance with the regulations on personal data, GDPR
- Support for data hosting
- Support in conducting impact analyses
- Assistance on the formalities to be accomplished, CNIL methodology
- Training of teams
- Drafting of procedures
- Creation of practical tools