Votre question concerne quel type d'offre ?
Votre question concerne quel couloir Ségur ?
Votre question concerne quel dispositif Ségur ?
Votre question concerne quel produit ou service produit?
Votre question concerne quelle thématique ?
To make sure your software complies with the guidelines required to implement INS into software, several documents are available:
Cette réponse vous a-t-elle été utile ?
The list of connected services is available online.
Cette réponse vous a-t-elle été utile ?
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:
Cette réponse vous a-t-elle été utile ?
Guarantees are set out on the dedicated page.
Cette réponse vous a-t-elle été utile ?
All the resources for funding are available in our Ségur section for digital equipment.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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:
Cette réponse vous a-t-elle été utile ?
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
75015 Paris - follow up with sending digital versions (PDF scans) of the agreement and its annexes, in two copies, signed and completed to:
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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)
Cette réponse vous a-t-elle été utile ?