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