2017/0379/F
EC/EFTA
FR France
  • SERV - SERVICES 98/48/CE
2017-11-13
2017-08-17

Services for hosting personal health data collected during prevention, diagnosis, treatment or social or socio-medical monitoring

Order approving the accreditation reference system for certification bodies and the certification reference system for hosting personal health data

This draft order is enacted pursuant to Article R1111-10 of the Public Health Code, as amended by the Decree on the hosting of personal health data (Notification No 2017/343/F). The order approves the following:

- the reference system regarding the accreditation of certification bodies for hosting personal health data,

- the reference system regarding certification for hosting personal health data.

In accordance with point II of Article L1111-8 of the Public Health Code, persons who host personal health data collected during prevention, diagnosis, treatment or social or socio-medical monitoring, on behalf of natural or legal persons behind the production or collection of said health data or on behalf of the patients themselves, must hold a certificate of conformity.

According to Article R1111-10, this certificate must be issued (1) by a certification body accredited in accordance with the accreditation reference system drawn up by the public interest group mentioned in Article L1111-24 in conjunction with the relevant accreditation bodies and (2) on the basis of a certification reference system drawn up by the same public interest group, after consultation with the French Data Protection Authority (CNIL).