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: 

In an inclusive way, all digital services aimed at citizens and useful for their healthcare can apply. Eligible services must be for the use of patients/citizens and proposed by public or private actors in the medical (health, wellness), social-medical, or social fields. The services must be included the definition set out by the L. 1111-13-1 bill:  

These services may include mobile apps, websites, connected objects, medical devices. They may be free services or not.  

Services in the realm of the EU regulation 2017/745 relating to medical devices must be conform to security and performance requirements. If your solution passes the conformity requirements, it will receive the CE label for medical devices.

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. 

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.).

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 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. 

In order for your service to be referenced in the My Health Space database, it must comply with the eHealth doctrine.

The doctrine is re-edited each year and defines the base rules of good practice for security, interoperability, and ethics applicable to eHealth services.

My Health Space includes the following health data: 

• The medical profile entered by the patient, in an unstructured format (preconditions, allergies); 
• Health measurements (weight, height, BMI, temperature, waist size, heart rate, blood pressure, glycemic index, level of pain) in FHIR format;  
• Health documents (for example: test and diagnosis results, hospitalisation reports, medical treatments).

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