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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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Generally speaking, the PGSSI-S needs to be applied as soon as personal health data are being handled. It is relevant to the public sector as well as the private sector, health professionals, workers of the social-health and social sectors, healthcare establishments and service providers.
As a patient, the PGSSI-S is a seal of guarantee on the accountability of digital health ecosystems.
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Complying with the PGSSI-S frames of reference is either required by law (if the documents have been approved by a ministerial decree) or meant to be followed on a short-term basis until the documents are approved by the ministry.
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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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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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