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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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In an inclusive way, all digital services aimed at citizens and useful for their healthcare can apply. Eligible services must be for the use of patients/citizens and proposed by public or private actors in the medical (health, wellness), social-medical, or social fields. The services must be included the definition set out by the L. 1111-13-1 bill:
These services may include mobile apps, websites, connected objects, medical devices. They may be free services or not.
Services in the realm of the EU regulation 2017/745 relating to medical devices must be conform to security and performance requirements. If your solution passes the conformity requirements, it will receive the CE label for medical devices.
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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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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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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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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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In order for your service to be referenced in the My Health Space database, it must comply with the eHealth doctrine.
The doctrine is re-edited each year and defines the base rules of good practice for security, interoperability, and ethics applicable to eHealth services.
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My Health Space includes the following health data:
- The medical profile entered by the patient, in an unstructured format (preconditions, allergies);
- Health measurements (weight, height, BMI, temperature, waist size, heart rate, blood pressure, glycemic index, level of pain) in FHIR format;
- Health documents (for example: test and diagnosis results, hospitalisation reports, medical treatments).
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