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.

Health CERT operates on weekdays between 9am and 6pm. Aside from these working hours, it is possible to contact the ANSSI to signal risks. 

CERT Santé 
+33 (0)9 72 43 91 25 
Agence du Numérique en Santé 
9 rue George Pitard, 75015 Paris

To register on the Convergence platform, you need to download the account request form to open an account as a company representative. 
Before completing this form, please check that your company is not already represented by another person who is able to create an account for you to access the Platform. If you have any questions, please contact support at ans-support-convergence@esante.gouv.fr. 
As soon as you receive the e-mail confirming the creation of your account, you will be able to initialize your password and access the Platform after accepting the General Terms of Use.

Yes. The ANS has a video platform with training material, including cybersecurity support. You will find information about cybersuveillance auditing, how to signal a security risk, how to increase your password security, and how to identity malicious email.

In order to request test products for certificates (CPS cards and test software certificates) issued by the IGC-Santé, go to our service page for the IGC-Santé.

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. 

Your level of access to the ROR data depends on the nature of the data you wish to use (public/restricted) and the perimeter you wish to cover (one ROR or several ROR directories).

The ROR data in public access:

• is available as opendata since mid-2022;
• will be available directly on the national ROR with no specific procedure in early 2023.

The ROR data in restricted access (professional access):

• for one regional ROR, you must complete a request form to join the regional circle of trust and send it to the region’s GRADeS;
• for several ROR directories, you must complete a request form to join the national circle of trust and send it to the ROR program team.

Healthcare industrials and software publishers are encouraged to contact Health CERT if they discover a security incident or potential malware. CERT provides assistance and support to resolve such issues. CERT also assists you in your communications to health structures.

You may divide your service into as many products as you wish to register on the platform. The appropriate segmentation must correspond to your activity and the roadmaps/processes available on the platform.  

It is important to include all the different versions associated with support or devices as different products, as they could impact the maturity level assessment of your solution.  

In order to make the identification of products easier, each edition and version of the commercialised products needs to be registered. We suggest you use this format to name your product - (Name of the Product) (OS) (Device) - with the following terms: 

• device can be named “Mobile” or “Website” 
• OS can be named “iOS”, “Android”, “Windows”, “Linux” or any other operating system. 

In addition, for registration into Mon Espace Santé (My Health Space): you must add as a product the solution that will be visible to the citizen/user in the service catalogue. The commercial name must be the same as the name visible by the citizen. 

The certificates that the ANS issues are an official means to identify the players of the health sector, persons and organisations. Certificates also act as a seal of quality, making sure that the issuing cryptographic key infrastructures (CKP) are conform to the sector’s best practice standards. Certificates can be revoked in case of failure to comply.

The Convergence platform supports you in developing your business and defining your plan for compliance with regulations specific to the e-health sector.

To this end, the platform is organized around two tracks:

• digital health doctrine ;
• My health space.

Each of these paths is broken down into steps:

• doctrine is divided into 4 steps: Evaluation and projection socles , Teleconsultation, teleexpertise, telecare;
• My Health Space is divided into 2 steps: referencing without data exchange and referencing with data exchange.

The procedures include questionnaires which, once completed, will enable you to assess the maturity and/or compliance of your products with the digital health doctrine, or the assessments required for My Health Space registration. 

The first step in completing the platform is to identify a manager who will oversee the completion operations. This person can then make an inventory of the products to be included in the scope of data entry, and list the resources to be mobilized: product managers, technical and functional experts, etc. Despite efforts to contextualize the questions, knowledge of healthcare IS interoperability, security and the ambitions of the doctrine of digital health is a prerequisite.

The questionnaires can then be read in groups. Based on the completion of an initial product, the reading of the questionnaires enables the identification of subjects that have been mastered, as well as those that require further investigation.

The pilot can then propose regular meetings with all product managers to monitor the progress of data entry, guarantee the consistency of responses and share expert feedback. 

There are two main user profiles on the Convergence platform:

• Manager: this is either the Corporate Officer or a person authorized by the Corporate Officer; he/she is authorized to add new contributors, create products and grant rights to contributors from his/her company;
• Contributor: authorized to create accounts for other contributors, create products and complete questionnaires, within the limits of the rights assigned to him/her.

Contributors are given access rights to questionnaires for products already created within the platform, and to questionnaires relating to global strategy.

Contributors who do not have the right to validate questionnaires can only save drafts for questionnaires to which they have access. 

The ANS offers 4 types of software certificates:

• Legal person (Organisation)
• Legal person (Server)
• Natural person (Professional)
• Natural person (Health Professional)

PLATINES is a platform dedicated to interoperability tests for eHealth. It stimulates a ROR (version 2.4) and gives you the opportunity to use “test” data via several professional cases (a total of 94 test scenarios are available). These test scenarios are valid for the current ROR as well as the national ROR.

You must contact the ROR program team to request access to PLATINES.