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 you with your projects’ and structures’ compliance with the data protection regulation, which strengthened itself since the application of the General Data Protection Regulation (GDPR), and the modification of the French Data Protection Law (LIL), as much in clinical trial, research, as for health data hosting, or health data warehouse.
We assist you in the regulation analysis, we give you our expertise in order to implement practical and operational solutions.
The office is a member of the AFCDP and participates to the work groups, in particular on health data.
- Assessment on the situational analysis, and compliance to the data privacy regulation, GDPR compliance
- Assistance with data hosting
- Support with Data Protection Impact Analsysis
- Help with procedures, CNIL methodologies