CNIL/France: Pior authorization for healthdata, pharmacovigilance and CNIL standards

Article by TwoBirds ” The CNIL published on 18 July 2019 a new standard concerning the processing of personal data for the purpose of vigilance in the health sector. ”

Quote: ” The standard is of great importance since according to the French Data Protection Act such processing activities are submitted to the CNIL’s prior authorization. The scope of the French prior authorization requirement is extraterritorial, and any organization worldwide doing product vigilance on individuals residing in France must obtain an authorization in order to be allowed to carry on their activities. But if their activities comply with the CNIL’s new standard, then they can now file a declaration of compliance with the CNIL, instead of filing a full request for authorization. “

Link to inofficial translation by TwoBirds at

TwoBird article on overall background at – incl. need for prior authorization and CNIL reference methods