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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 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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The open access data is free to download. However, the user must be mindful of the General Conditions when working with the Health Pro Directory information.
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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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All the resources for funding are available in our Ségur section for digital equipment.
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For your application to be complete, you need to include several credentials and documents.
The list of documents and credentials needed is detailed in the Application form (download it below). You will need to send and application for each product you wish to label.
You must return your application form with all the supporting material by email AND via postal services:
- the complete application form needs to be sent by mail to:
Agence du numérique en santé (ANS)
Labellisation logiciel Maisons et Centres de Santé
9, rue Georges Pitard
75015 Paris - follow up with sending digital versions (PDF scans) of the agreement and its annexes, in two copies, signed and completed to:
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The update frequency depends on the source of the data. Data is updated daily when it comes from entities such as: national councils for the Ordres, the army health service, the FINESS directory, the CPx card information system; the MSSanté information system. Data coming from regional health agencies is updated on a weekly basis.
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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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When your software gets the label attribution, the successful candidate will receive by email the visual elements you will need to communicate about it.
The editor of the solution (or the solution range) will receive the label after signing the agreement with the ANS. They will be able to use the label on commercial publications, technical documents, with no particular restriction on the type of format used (paper, Internet, intranet, etc.)
The recipient must mention the level of the label (1 or 2) they obtained. These specifications are set out in the Functional referential (in our Documentation section)
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No, a person may only have one e-CPS card at a time.
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The CPS card and e-CPS are two complementary means of authentication. A person may use both at the same time, or one or the other according to their preference.
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The professionals included in the Health Pro Directory are those listed in the RPPS by the Ordres (civil health professional) and the Army Health Service – SSA (military health professional):
- Doctors
- Pharmacists
- Dentists
- Midwives
- Physical therapists (Kine)
- Chiropodists
- Nurses
Professions listed in ADELI:
- Social service assistants Dental assistants
- Audioprosthesists
- Chiropractors
- Nutritionists
- Epithesists
- Ergotherapists
- Radiologists
- Ocularists
- Opticians
- Orthopaedist
- Speech therapists
- Psychologist
- Psycho-motor therapist
- Lab technicians
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