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All the rules are set out in the HDS certification – Accreditation reference system and the COFRAC’s "Exigences spécifiques pour l’accréditation des organismes procédant à la certification de systèmes de management dans le domaine des technologies de l’information" (Specific requirements for structures that certify management systems in the information technology sector), available in our Documentation section.
To find out more about the list of certified and accredited bodies, click on the links below.
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There are 6 types of activities that make you eligible as a health data host:
- providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
- providing and maintaining the structural material used by the IS to host health data;
- providing and maintaining a platform that hosts the IS applications;
- providing and maintaining a digital structure for the IS which hosts health data;
- the administration and exploitation of the IS which contains the health data;
- health data backup services.
The full list of HDS-certified activities is available here:
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The evaluation is done in two phases. It is conducted by the certifying body, which must verify the compliance with the certification requirements set out in the HDS Certification document (available below).
The audit also verifies the specific requirements for health data hosting are being met.
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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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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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