Personal health details are sensitive data and they are regulated by law to protect our rights. As a result, this data has to be hosted with security safeguards that adequately reflect its critical nature. The regulatory framework defines the required modalities.

"All physical and legal persons hosting data of a personal nature gathered for the purposes of preventive treatment, diagnosis, healthcare or social care on behalf of physical or legal persons who have produced or gathered that data, or on behalf of the patients themselves, must be accredited or certified to that effect."

L.1111-8 of the Public Health Code (in French)

Those hosting health data digitally (except in the case of electronic archives) must be certified.
This certification is replacing the accreditation that has until now been issued by the Ministry of Health (FR MoH) in line with the provisions of Decree N°2006-6 of 4 January 2006 (in French).

Decree 2018-137 of 26 February 2018 (in French) stipulates the certification procedure and modalities of transition from the old accreditation to the new certification. The decree approving the accreditation and certification reference texts published on 29 June 2018 signalled the introduction of the Health Data Hosting (HDS) certification system. Hosts can request a Health Data Hosting (HDS) certificate from any certifying body that has obtained accreditation from COFRAC.

The procedures

The hosting of health data must be carried out by an accredited or certified operator.