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:
- 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
- follow up with sending digital versions (PDF scans) of the agreement and its annexes, in two copies, signed and completed to:
There are 6 types of activities that make you eligible as a health data host:
- providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
- providing and maintaining the structural material used by the IS to host health data;
- providing and maintaining a platform that hosts the IS applications;
- providing and maintaining a digital structure for the IS which hosts health data;
- the administration and exploitation of the IS which contains the health data;
- health data backup services.
The full list of HDS-certified activities is available here:
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 ANS conducted a study on telehealth in France, based on 14 practices covering 11 specialties. These are:
nephrology, geriatrics, cardiology, orthopedics/traumatology, anethesia, psychiatry, gerontopsychiatry (teleconsultation practices);
neuropediatrics, dermatology, maxillofacial surgery (tele-expertise practices);
ophthalmology, medical and surgical neurology, tele-radiology, chronic wounds treatment (multi-act practices).
These practices are presented as fact sheets in the document below “Restitution des cas d’usage en télémédecine”
To initiate the process, click on Add a product. A product identification and a product qualification questionnaire invite you to register:
- the name of the product, its versions, its identification number (NIL number, issued by the CNDA), its description and its certifications;
- technical or functional specificities;
- the referencing process you wish to apply for when you finish creating the product.
The qualification questionnaire specifies technical and functional features and customises the maturity questionnaires you will have to fill in later during the application process.
When you submit the identification and qualification questionnaires, the product is created. The platform will then ask you to select the evaluation module you wish to register the product in. You may also add a product into a module from the product page or from the module’s presentation page.
The accountability referential defines the means useable for:
- tracing the actions done on a health IS;
- guarantee the value of each registered action;
- control the use of this health IS.
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
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.
The eHealth doctrine identifies several data directories, each with a specific target:
- the extended RPPS (or RPPS+) to identify each physical person in their role as a health professional (all types of professionals or assistants in the sector);
- the revised FINESS(or FINESS+) to identify each moral person in the health sector (all establishments or judicial entities in the sector);
- the ROR to describe the extend of the health offer within a facility or establishment (specialties, capacity, etc.).
To start completing the platform, it is necessary in the first place to identify a “pilot” person who will be responsible for the completion operations. The pilot will list the products, which need to integrate the entry perimeter and the list of resources needed - they can be product owners, technical experts, functional experts...
Although the questions have been contextualised, some knowledge of health IS interoperability, security and the main goals of the eHealth doctrine is a prerequisite.
Some time may be allocated to organise group questionnaire readings. From the completion of a first product, the questionnaire reading will be useful to identify topics that are under control and topics that need to be addressed.
Then, the pilot can organise punctual meetings in order to follow the project’s completion progress, make sure the answers are coherent and share experts’ feedback.