What is HDS Certification?
Personal health details are sensitive data and they are regulated by law to protect our rights. As a result, this critical information has to be hosted with the adequate security level. The HDS Reference System defines these requirements.
Any organisation hosting health data digitally (aside from digital archives) must be certified.
In 2018, this certification replaced the accreditation that was issued by the Ministry of Health. The HDS certification has become a selling point for the Information Systems Directors (DSI) of health structures. One exception: in some cases, Territorial Hospital Groups (GHT) can be exempt from certification.
The HDS certification provides 3 major benefits for digital solutions publishers:
- Protect and secure sensitive health data;
- Align the regulatory frameworks of all HDS structures;
- Ensure the security of a particular health structure (laboratory, sanitary, research) if there are no requirements in place yet.
HDS certification in 1 click
Understanding HDS in 3 minutes
To host health data on digital platforms, you must be an accredited or certified operator, unless you manage a digital archive.
The French law (Decree 2018-137 of 26 February 2018) stipulates the certification procedure and modalities of transition from the former system (accreditation) to the new certification programme.
Hosts can request a Health Data Hosting (HDS) certificate from any certifying body that has obtained accreditation from the COFRAC (French Committee for Accreditation) or a similar organisation at the European level.
HDS in numbers
42 HDS structures verified by the French Ministry of Health, with the former procedure (HDS Accreditation)
189 HDS services received a certification by the end of 2021, following the new procedure (HDS Certification)
8 Organisations are currently able to provide a HDS certification
HDS Certification: How does it work ?
The ANS provides you with the documentation you need
Key service dates
The ANS publishes the HDS Accreditation Reference System online
HDS accreditation is introduced for digital platforms
Due to the Covid-19 outbreak, all valid accreditations are extended; the new HDS certificates are also being rolled out as planned
Frequently Asked Questions
The ANS answers the most common questions about HDS certification.
There are 6 types of activities that make you eligible as a health data host:
- providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
- providing and maintaining the structural material used by the IS to host health data;
- providing and maintaining a platform that hosts the IS applications;
- providing and maintaining a digital structure for the IS which hosts health data;
- the administration and exploitation of the IS which contains the health data;
- health data backup services.
The full list of HDS-certified activities is available here:
All the rules are set out in the HDS certification – Accreditation reference system and the COFRAC’s "Exigences spécifiques pour l’accréditation des organismes procédant à la certification de systèmes de management dans le domaine des technologies de l’information" (Specific requirements for structures that certify management systems in the information technology sector), available in our Documentation section.
To find out more about the list of certified and accredited bodies, click on the links below.
The evaluation is done in two phases. It is conducted by the certifying body, which must verify the compliance with the certification requirements set out in the HDS Certification document (available below).
The audit also verifies the specific requirements for health data hosting are being met.