To make sure your software complies with the guidelines required to implement INS into software, several documents are available:

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.

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

Our partner, the GIE Sesam-Vitale, is here to provide you with support and answer your questions about your software project, how to integrate INSi, or solve any potential technical setbacks. 

The helpdesk is available by phone at +33 (0)2 43 57 42 88, from 9am to 12noon, and from 2pm to 6pm, Monday to Friday. You may also send an email to centre-de-service@sesam-vitale.fr.

In order to make the check lists more transparent and reduce the risk of seeing your Ségur application denied, we have published a document listing common mistakes, which is available below:

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".

Upgrading your products allows you to offer your customers a solution that complies with current regulations. Failure to meet this requirement will have several impacts: 

• Your customers will not incorporate the INS into their software, which will entail possible penalties with regard to several systems (Ségur Wave 1, HOPEN, portal listing in Mon Espace Santé, etc.) ; 

• Your customers will not be in compliance with the law. They will therefore be responsible for any errors in the identification of their patients and users ; 

• Sharing health data by your customers will be more time consuming ; 

• The identity used by your customers may not be the right one, for instance if a patient uses their married name or if the patient is a child registered under their parent’s social security number.

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)

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

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).