The cost is determined by the certifying body which grants the certificate.

The daily cost to conduct the audits is at their discretion. The industrial is free to choose which certifying body they want to work with to become certified.

For further information on this topic, we suggest you contact the certifying bodies that have signed a convention agreement with the ANS, listed below:

The service is only available for foreign patients that meet the following criteria:

• the patient must come from an EU country providing the Sesali service;
• the patient must have activated the service (depending on their country);
• the patient must have a medical summary in file in their country’s systems.

The list of eligible nationalities is available on the Sesali.fr homepage.

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.

Your application needs to be complete and signed, with all the following documents:

• the MDPH label rules, which describes the labelling process  
• the convention regarding the use of the label, which defines the procedures that take place after the label is granted. For example: obligations tied to the label, audit visits, cases of modifying the label, etc. 
• the annexes to the convention; 
• the license of use for the labelled solution; 
• the insurance security plan for the conformity checks relating to the MDPH label; 
• if applicable, the decisions issued by partner organisations dealing with exchange fluxes (CNAF/SNGI, Imprimerie Nationale, etc.) to attest you are using the correct one. 

The application must be sent in paper AND via electronic mail to: 

Agence du Numérique en Santé 
Labellisation logiciels Maisons Départementales des Personnes Handicapées 
9 rue Georges Pitard 75015 Paris 

labellisation.mdph@esante.gouv.fr 

These documents are made available by the CNDA as a .zip file below.

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 application for the SI-MDPH label is open to any legal entity with a software solution aimed at the departmental disability centres (MDPHs). This includes the MDPHs themselves, which develop their own solutions in conjunction with the relevant Departmental Council.  

The label application is a voluntary process: Anyone can be a candidate if they feel that their solution complies with the current requirements and the scope of the sector’s functional standards.

Yes, you need to have the ISO 9001 or the ISO 13485 certification to be eligible. You may begin the QHN certification process while you are in the course of making an application for/or renewing these ISO 9001 or the ISO 13485 certifications.

Yes, as long as the industrial remains responsible for the compliance of these processes with the requirements set out to obtain the QHN certification – regardless of hired external contractors or if some of the components are published or made by third-party companies.

Indeed, in the whole production system’s organisation, the industrial is the direct contact with a health professional or structure, and must make sure each requirement set out in the “Référentiel Qualité Hôpital Numérique” (QHN Referential, available in our Documentation section) is met.

Access to the service may be restricted for the following reasons:

• you do not specialise in occupational medicine
• you work for a private insurance company
• you no longer practise
• your CPS card has expired or been revoked
• your web browser is not compatible
• you are using a mobile appliance (smartphone or tablet)
• you are not included in the following list of health professionals:
  • general practitioners and specialists (radiologists, biologists, independent, employee, Samu-Emergencies-C.15, interns)
  • biological pharmacists and interns
  • pharmacists in dispensaries or hospitals
  • dental surgeon, interns
  • midwives
  • nurses
  • physical therapist
  • pedicure-podiatrists
  • speech therapists
  • ergotherapists, psychomotor specialists, orthopists, dieticians
  • medical radiologists

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.