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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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There are two steps to follow:
Step 1: Administrative phase
Should you wish to order test CPS cards or register authorisations for test software, you may:
- read our complete products offer ;
- place an order
To place an order, select your Profile and your Structure, then choose “Produits de développement. Commander des produits de développement : carte et/ou certificat logiciel de test" (Test products for products, cards and/or test software).
Step 2: Technical phase
Use the card you validated after step 1 in order to connect with the Trusted Platform IGC-Santé. You will be able to order, withdraw, monitor and revoke test certificates through the IHM or Webservice interface.
In order to do so, make sur you have inserted your test card in the card reader.
Read more about specific setup guidelines:
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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:
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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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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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The IGC-Santé is dedicated to the health sector and follows strict procedures in terms of data collection, professional identification, and works with certified authorities (RPPS register, etc.).
The certificates issued by the IGC guarantee the security of software or electronic cards, such as the CPS card.
The IGC also manages the publication of these certificates and can revoke them – this is signalled to the apps using certificates in revocation listings.
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There are two main reasons for the creation of IGC-Santé :
- guaranteeing the security of private keys and certificates issued by the ANS: the access to these private keys must be limited in order to prevent duplicates or their installation more than one device;
- maintaining a continuity in services: many health apps used to work on certificates issued by former CKI that ceased their activity in January 2021. These apps must be compatible with certificates issued by the IGC-Santé.
In addition, these certificates meet the security standards (risk analysis, safety policies), or “Certifying Policies” that comply with the PGSS-IS guidelines.
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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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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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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.
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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.
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