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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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In order to request test products for certificates (CPS cards and test software certificates) issued by the IGC-Santé, go to our service page for the IGC-Santé.
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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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There are several levels of requirements for a module’s integration into the Hospital Information System.
The main requirements set out by the referential are:
- Interfacing, control, security guidelines;
- Prescription process requirements;
- National prescription thesaurus integration requirements;
- Requirements regarding medico-economic and decision processes;
- Guidelines for ergonomics, functions, and notification alerts;
- Settings function requirements.
In total, 139 requirements are used to reach the minimal level of security needed for a solution’s integration into the hospital information system.
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The current referential (2017) was written with industry experts. It introduces the particular context of this mission and the goals to reach in order to improve safety measures in neonatology and paediatric reanimation. The referential walks you through the fundamental concepts you need to grasp to understand the several requirements and protocols involved with software development for this sector.
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Neonatology is a high-risk practice for two main reasons:
- The patients are extremely fragile (premature babies)
- 50% of the drugs used in the sector have yet to receive a marketing authorisation.
A survey conducted in 2014 evidenced a risk in the prescription process across the sector. The digitalisation of prescription is among the 41 recommendations that the report issued in order to increase safety levels.
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The certificates that the ANS issues are an official means to identify the players of the health sector, persons and organisations. Certificates also act as a seal of quality, making sure that the issuing cryptographic key infrastructures (CKP) are conform to the sector’s best practice standards. Certificates can be revoked in case of failure to comply.
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The ANS offers 4 types of software certificates:
- Legal person (Organisation)
- Legal person (Server)
- Natural person (Professional)
- Natural person (Health Professional)
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