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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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The ANS conducted a study on telehealth in France, based on 14 practices covering 11 specialties. These are:
- nephrology, geriatrics, cardiology, orthopedics/traumatology, anethesia, psychiatry, gerontopsychiatry (teleconsultation practices);
- neuropediatrics, dermatology, maxillofacial surgery (tele-expertise practices);
- ophthalmology, medical and surgical neurology, tele-radiology, chronic wounds treatment (multi-act practices).
These practices are presented as fact sheets in the document below “Restitution des cas d’usage en télémédecine”
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The study conducted by the ANS helped establish that the equipment used in telehealth practices can be :
- A space dedicated to telehealth
- A teleconsultation booth
- A console with screen
- A teleconsultation cart
- A visioconference cart
- A PACS console
- A computer with webcam
- A digital tablet
- A smartphone
- Carte Vitale reader
- Digital dermatoscope
- Digital otoscope
- Digital ophthalmoscope
- Digital fundus camera
- Connected echograph scanner
- Connected thermometer, stetoscope, scale and tensionmeter
Further information is available in the Documentation.
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The list of connected services is available online.
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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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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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The service is only available for foreign patients that meet the following criteria:
- the patient must come from an EU country providing the Sesali service;
- the patient must have activated the service (depending on their country);
- the patient must have a medical summary in file in their country’s systems.
The list of eligible nationalities is available on the Sesali.fr homepage.
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Guarantees are set out on the dedicated page.
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To register on the Convergence platform, you need to download the account request form to open an account as a company representative.
Before completing this form, please check that your company is not already represented by another person who is able to create an account for you to access the Platform. If you have any questions, please contact support at ans-support-convergence@esante.gouv.fr.
As soon as you receive the e-mail confirming the creation of your account, you will be able to initialize your password and access the Platform after accepting the General Terms of Use.
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In order to request test products for certificates (CPS cards and test software certificates) issued by the IGC-Santé, go to our service page for the IGC-Santé.
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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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Your application needs to be complete and signed, with all the following documents:
- the MDPH label rules, which describes the labelling process
- the convention regarding the use of the label, which defines the procedures that take place after the label is granted. For example: obligations tied to the label, audit visits, cases of modifying the label, etc.
- the annexes to the convention;
- the license of use for the labelled solution;
- the insurance security plan for the conformity checks relating to the MDPH label;
- if applicable, the decisions issued by partner organisations dealing with exchange fluxes (CNAF/SNGI, Imprimerie Nationale, etc.) to attest you are using the correct one.
The application must be sent in paper AND via electronic mail to:
Agence du Numérique en Santé
Labellisation logiciels Maisons Départementales des Personnes Handicapées
9 rue Georges Pitard 75015 Paris
labellisation.mdph@esante.gouv.fr
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All the resources for funding are available in our Ségur section for digital equipment.
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These documents are made available by the CNDA as a .zip file below.
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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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It is compulsory to have an individual CPx-type card to log in to the INSi teleservice. Three types of cards are supported: CPS, CPE, CPF.
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CPx cards issued before December 2020 have a contactless chip that prevents from overwriting its code.
The new CPS R3V3 cards that are now in circulation have a Mifare Desfire chip. These cards can stock crypto-secret keys that work with the Mifare Desfire protocol.
All the information about this feature is available in the Manual to deploy contactless CPx cards (available to download below). One must be cautious about the data inserted in the chip’s writing code.
We strongly advise against using this section of the chip to stock access rights. The ANS recommends you to use the ANSSI guidelines on using a "transparent" reader in connected mode. This does not involve a cryptographic protocol during a badge authentication – only the UTL (logic treatment unit) takes part in the cryptographic protocol.
ANSSI advises against setting up a “smart” badge allowing a double authentication breaking from the UTL.
All the recommendations on securing systems for physical access and video projection are available in the document below, "Recommendations on securing systems for physical and video projection access".
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You may divide your service into as many products as you wish to register on the platform. The appropriate segmentation must correspond to your activity and the roadmaps/processes available on the platform.
It is important to include all the different versions associated with support or devices as different products, as they could impact the maturity level assessment of your solution.
In order to make the identification of products easier, each edition and version of the commercialised products needs to be registered. We suggest you use this format to name your product - (Name of the Product) (OS) (Device) - with the following terms:
- device can be named “Mobile” or “Website”
- OS can be named “iOS”, “Android”, “Windows”, “Linux” or any other operating system.
In addition, for registration into Mon Espace Santé (My Health Space): you must add as a product the solution that will be visible to the citizen/user in the service catalogue. The commercial name must be the same as the name visible by the citizen.
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