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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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Health CERT operates on weekdays between 9am and 6pm. Aside from these working hours, it is possible to contact the ANSSI to signal risks.
CERT Santé
+33 (0)9 72 43 91 25
Agence du Numérique en Santé
9 rue George Pitard, 75015 Paris
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Yes. The ANS has a video platform with training material, including cybersecurity support. You will find information about cybersuveillance auditing, how to signal a security risk, how to increase your password security, and how to identity malicious email.
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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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Healthcare industrials and software publishers are encouraged to contact Health CERT if they discover a security incident or potential malware. CERT provides assistance and support to resolve such issues. CERT also assists you in your communications to health structures.
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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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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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