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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.
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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
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These documents are made available by the CNDA as a .zip file below.
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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.
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A base product (“Produit socle”) is a solution, a service, or device sold by an eHealth industrial, which is aimed at fulfilling the needs of a particular activity, practice or profession. It is not bound to the purchase of a previous product. It may be completed with Option Products (“Produit option”) to extend its functional coverage.
An option product (“Produit option”) is a solution, service, or device sold by an eHealth industrial to meet specific needs extending the functional perimeter of one or several base products (“produits socle”) to which it adds on. This means a base product must be purchased, prior to the use of an option product.
In the case of a base product being offered as an option to another product, we suggest you first declare the product as a “produit socle”. Then you will be able, from this entry, to duplicate and convert the product as a “produit option”.
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Yes, the applications close before the end of the first Ségur wave to allow enough time for the solutions implementation.
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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.
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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).
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