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: 

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.

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. 

All the resources for funding are available in our Ségur section for digital equipment.

For your application to be complete, you need to include several credentials and documents.

The list of documents and credentials needed is detailed in the Application form (download it below). You will need to send and application for each product you wish to label.

You must return your application form with all the supporting material by email AND via postal services:

1. the complete application form needs to be sent by mail to:

   Agence du numérique en santé (ANS)
   Labellisation logiciel Maisons et Centres de Santé
   9, rue Georges Pitard
   75015 Paris

2. follow up with sending digital versions (PDF scans) of the agreement and its annexes, in two copies, signed and completed to:

   labellisation.msp@esante.gouv.fr

It is compulsory to have an individual CPx-type card to log in to the INSi teleservice. Three types of cards are supported: CPS, CPE, CPF. 

CPx cards issued before December 2020 have a contactless chip that prevents from overwriting its code.

The new CPS R3V3 cards that are now in circulation have a Mifare Desfire chip. These cards can stock crypto-secret keys that work with the Mifare Desfire protocol.

All the information about this feature is available in the Manual to deploy contactless CPx cards (available to download below). One must be cautious about the data inserted in the chip’s writing code.

We strongly advise against using this section of the chip to stock access rights. The ANS recommends you to use the ANSSI guidelines on using a "transparent" reader in connected mode. This does not involve a cryptographic protocol during a badge authentication – only the UTL (logic treatment unit) takes part in the cryptographic protocol.

ANSSI advises against setting up a “smart” badge allowing a double authentication breaking from the UTL.

All the recommendations on securing systems for physical access and video projection are available in the document below, "Recommendations on securing systems for physical and video projection access".

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. 

When your software gets the label attribution, the successful candidate will receive by email the visual elements you will need to communicate about it.

The editor of the solution (or the solution range) will receive the label after signing the agreement with the ANS. They will be able to use the label on commercial publications, technical documents, with no particular restriction on the type of format used (paper, Internet, intranet, etc.) 
The recipient must mention the level of the label (1 or 2) they obtained. These specifications are set out in the Functional referential (in our Documentation section)

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. 

This midware allows the interfacing between computer applications, such as the Vivoptim doctors portal and the CPS card.