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The accountability framework defines the means that can be used to:
- ensure traceability of actions carried out in relation to a healthcare IS;
- guarantee the value of recorded traces;
- control the use made of this healthcare IS.
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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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A software publisher usually integrates several terminologies that cover standard usages: common names and codes, language names and codes, countries...
Then they integrate “Base Terminologies” (drug terminologies, billing, administrative) and occupation-specific terminologies (Terminology of the living, cardiology terminology, geriatric terminologies, etc.).
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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 State evaluates the following criteria:
- Terminology conceived by one of the ANS’ Production Units
- Terminology conceived by a Production Unit with a convention
- Terminology in usage
- Terminology compatible with the ANS right imposition
- Reference terminology
- “Open” terminology
- Maturity of the Production Unit in charge of the terminology’s conception and maintenance
- Local terminology sets (“small terminologies”)
- Terminology conceived by a “fragile” Production Unit / Terminology conceived by a Production Unit without a distribution point
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