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To make sure your software complies with the guidelines required to implement INS into software, several documents are available:
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The accountability framework defines the means that can be used to:
- ensure traceability of actions carried out in relation to a healthcare IS;
- guarantee the value of recorded traces;
- control the use made of this healthcare IS.
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All the resources for funding are available in our Ségur section for digital equipment.
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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.
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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:
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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:
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Generally speaking, the PGSSI-S needs to be applied as soon as personal health data are being handled. It is relevant to the public sector as well as the private sector, health professionals, workers of the social-health and social sectors, healthcare establishments and service providers.
As a patient, the PGSSI-S is a seal of guarantee on the accountability of digital health ecosystems.
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Complying with the PGSSI-S frames of reference is either required by law (if the documents have been approved by a ministerial decree) or meant to be followed on a short-term basis until the documents are approved by the ministry.
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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:
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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.) ;
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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 ;
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Sharing health data by your customers will be more time consuming ;
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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.
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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)
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