Privacy / Regulation

CNIL sets out GDPR duties for internal research by health professionals using patient care data

Internal research projects need no prior CNIL formalities, but the regulator says they remain subject to GDPR records, impact assessments, patient information and the right to object.

GuidanceFranceNotablePublishedOfficial source
3 conditions: Cumulative criteria a health research project must meet to count as 'internal'

France’s data protection authority, the CNIL, has published guidance on “internal research” carried out by health professionals. A project qualifies only if it meets three cumulative conditions. It must use data collected during patients’ individual care, be carried out by the staff providing that care, and be for those staff’s exclusive use.

Such projects need no prior formalities with the CNIL. They still fall under the GDPR’s general duties, including entries in the record of processing, a possible data protection impact assessment and informing patients under Articles 12 to 14. The CNIL recommends layered notices and allows collective information only where individual notice would demand disproportionate effort. The right to object under Article 21 applies.

Projects that miss any criterion need a declaration of conformity with a reference framework or prior CNIL authorisation. Results may be used to inform the public and the scientific community, but access to participants’ health data must stay restricted to the care team unless the data has been anonymised.

Why it matters

Hospitals and clinics should check that every study they treat as internal meets all three criteria. Each one also needs an entry in the record of processing and an assessment of whether a DPIA is needed. Data stewards should confirm that health data shared outside the care team is truly anonymised rather than pseudonymised, because pseudonymised data stays within the GDPR. Patient notices and transparency portals should cover internal research and explain how patients can object.

Status: Published. applies to health research in France

Sources

  1. Recherches internes : quelles sont les obligations pour les professionnels de santé ? — CNILPrimary source

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Who should care

  • DPO
  • Legal & compliance
  • Data stewards
  • Research governance leads

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