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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 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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Your level of access to the ROR data depends on the nature of the data you wish to use (public/restricted) and the perimeter you wish to cover (one ROR or several ROR directories).
The ROR data in public access:
- is available as opendata since mid-2022;
- will be available directly on the national ROR with no specific procedure in early 2023.
The ROR data in restricted access (professional access):
- for one regional ROR, you must complete a request form to join the regional circle of trust and send it to the region’s GRADeS;
- for several ROR directories, you must complete a request form to join the national circle of trust and send it to the ROR program team.
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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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A base product (“Produit socle”) is a solution, a service, or device sold by an eHealth industrial, which is aimed at fulfilling the needs of a particular activity, practice or profession. It is not bound to the purchase of a previous product. It may be completed with Option Products (“Produit option”) to extend its functional coverage.
An option product (“Produit option”) is a solution, service, or device sold by an eHealth industrial to meet specific needs extending the functional perimeter of one or several base products (“produits socle”) to which it adds on. This means a base product must be purchased, prior to the use of an option product.
In the case of a base product being offered as an option to another product, we suggest you first declare the product as a “produit socle”. Then you will be able, from this entry, to duplicate and convert the product as a “produit option”.
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PLATINES is a platform dedicated to interoperability tests for eHealth. It stimulates a ROR (version 2.4) and gives you the opportunity to use “test” data via several professional cases (a total of 94 test scenarios are available). These test scenarios are valid for the current ROR as well as the national ROR.
You must contact the ROR program team to request access to PLATINES.
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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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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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