Health & Life Sciences

Yes, for most care activities: hospitalisation, surgery, imaging, dialysis, etc. The ARS (regional health agency) grants the authorisation after reviewing a file demonstrating that a health need is met and that the technical standards are complied with. The regime varies according to the activity and the geographical area.

The SEL (liberal-profession company) is the most common form: it allows several practitioners to associate while preserving professional independence. The SPFPL (liberal-profession financial holding company) makes it possible to hold shares in an SEL. An SCM (resource-pooling company) serves solely to share resources without joint practice.

Manufacturers of medical devices and medicinal products must set up device vigilance or pharmacovigilance: declaration of incidents to the ANSM, traceability, recalls where applicable. Non-compliance exposes them to administrative, civil and criminal sanctions, including withdrawal of the marketing authorisation or CE marking.

By a request for reconsideration addressed to the authority, then possibly a contentious appeal to the administrative court. The deadlines are short (generally 2 months). The key is to build a solid factual and legal case: lack of reasoning, error of law, disproportionate sanction, procedural defect.

Health data is sensitive data within the meaning of the GDPR: its processing is subject to strict conditions (explicit consent, hosting with a certified HDS host, impact assessment, DPO, processing register). Sanctions of up to 4% of worldwide turnover apply in the event of a serious breach.