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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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Your level of access to the ROR data depends on the nature of the data you wish to use (public/restricted) and the perimeter you wish to cover (one ROR or several ROR directories).
The ROR data in public access:
- is available as opendata since mid-2022;
- will be available directly on the national ROR with no specific procedure in early 2023.
The ROR data in restricted access (professional access):
- for one regional ROR, you must complete a request form to join the regional circle of trust and send it to the region’s GRADeS;
- for several ROR directories, you must complete a request form to join the national circle of trust and send it to the ROR program team.
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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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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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A base product (“Produit socle”) is a solution, a service, or device sold by an eHealth industrial, which is aimed at fulfilling the needs of a particular activity, practice or profession. It is not bound to the purchase of a previous product. It may be completed with Option Products (“Produit option”) to extend its functional coverage.
An option product (“Produit option”) is a solution, service, or device sold by an eHealth industrial to meet specific needs extending the functional perimeter of one or several base products (“produits socle”) to which it adds on. This means a base product must be purchased, prior to the use of an option product.
In the case of a base product being offered as an option to another product, we suggest you first declare the product as a “produit socle”. Then you will be able, from this entry, to duplicate and convert the product as a “produit option”.
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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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PLATINES is a platform dedicated to interoperability tests for eHealth. It stimulates a ROR (version 2.4) and gives you the opportunity to use “test” data via several professional cases (a total of 94 test scenarios are available). These test scenarios are valid for the current ROR as well as the national ROR.
You must contact the ROR program team to request access to PLATINES.
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