The protection of scientific and medical data, as well as of 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 pharmacovigilance, led the French Data Protection Authority (“CNIL” in France) to set up « methodologies » and specific documents.
The sensitivity of health data and the potential impact of a 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 help our clients to be fully compliant with both the new GDPR requirements as well as with the recent enhancements of the French data protection law whether it is for clinical research purposes, health data hosting or health data warehouse.
We provide you with the applicable legal and regulatory framework and help transposition into simple and actionable business solutions.
The office is a member of the AFCDP and participates to the work groups, in particular on health data.
- Assessment of compliance to data privacy regulations including GDPR-readiness
- Assistance with data hosting
- Support with Data Protection Impact Analsysis
- Help with procedures, CNIL methodologies