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.

There are 6 types of activities that make you eligible as a health data host:

1. providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
2. providing and maintaining the structural material used by the IS to host health data;
3. providing and maintaining a platform that hosts the IS applications;
4. providing and maintaining a digital structure for the IS which hosts health data;
5. the administration and exploitation of the IS which contains the health data;
6. health data backup services.

The full list of HDS-certified activities is available here: 

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. 

A software publisher usually integrates several terminologies that cover standard usages: common names and codes, language names and codes, countries... 

Then they integrate “Base Terminologies” (drug terminologies, billing, administrative) and occupation-specific terminologies (Terminology of the living, cardiology terminology, geriatric terminologies, etc.).

There are several levels of requirements for a module’s integration into the Hospital Information System. 

The main requirements set out by the referential are: 

• Interfacing, control, security guidelines; 
• Prescription process requirements; 
• National prescription thesaurus integration requirements; 
• Requirements regarding medico-economic and decision processes; 
• Guidelines for ergonomics, functions, and notification alerts; 
• Settings function requirements. 

In total, 139 requirements are used to reach the minimal level of security needed for a solution’s integration into the hospital information system.

The current referential (2017) was written with industry experts. It introduces the particular context of this mission and the goals to reach in order to improve safety measures in neonatology and paediatric reanimation. The referential walks you through the fundamental concepts you need to grasp to understand the several requirements and protocols involved with software development for this sector.

Neonatology is a high-risk practice for two main reasons:

• The patients are extremely fragile (premature babies) 
• 50% of the drugs used in the sector have yet to receive a marketing authorisation.

A survey conducted in 2014 evidenced a risk in the prescription process across the sector. The digitalisation of prescription is among the 41 recommendations that the report issued in order to increase safety levels.

No, a person may only have one e-CPS card at a time.

The national ID is:

• One the first line of your CPx-type card
• Add “8” before your RPPS ID, for example 81234567890
• Add “0” before your ADELI ID, for example 01234567890

The CPS card and e-CPS are two complementary means of authentication. A person may use both at the same time, or one or the other according to their preference.

Yes, the applications close before the end of the first Ségur wave to allow enough time for the solutions implementation.

The State evaluates the following criteria: 

• Terminology conceived by one of the ANS’ Production Units
• Terminology conceived by a Production Unit with a convention
• Terminology in usage
• Terminology compatible with the ANS right imposition
• Reference terminology
• “Open” terminology
• Maturity of the Production Unit in charge of the terminology’s conception and maintenance
• Local terminology sets (“small terminologies”)
• Terminology conceived by a “fragile” Production Unit / Terminology conceived by a Production Unit without a distribution point