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.

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.

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)

To access your personal account on Convergence, you will need to log in with the “User Name” (“Nom d’utilisateur”) sent to you when you register. This login may differ from the email address associated with your account. 

A user has a unique login and email address on the Platform. Therefore, it is not possible to create two accounts with the same email address or login information. 

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”.

The certificates that the ANS issues are an official means to identify the players of the health sector, persons and organisations. Certificates also act as a seal of quality, making sure that the issuing cryptographic key infrastructures (CKP) are conform to the sector’s best practice standards. Certificates can be revoked in case of failure to comply.

No, a person may only have one e-CPS card at a time.

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.

The Convergence platform supports you in developing your business and defining your plan for compliance with regulations specific to the e-health sector.

To this end, the platform is organized around two tracks:

• digital health doctrine ;
• My health space.

Each of these paths is broken down into steps:

• doctrine is divided into 4 steps: Evaluation and projection socles , Teleconsultation, teleexpertise, telecare;
• My Health Space is divided into 2 steps: referencing without data exchange and referencing with data exchange.

The procedures include questionnaires which, once completed, will enable you to assess the maturity and/or compliance of your products with the digital health doctrine, or the assessments required for My Health Space registration. 

The first step in completing the platform is to identify a manager who will oversee the completion operations. This person can then make an inventory of the products to be included in the scope of data entry, and list the resources to be mobilized: product managers, technical and functional experts, etc. Despite efforts to contextualize the questions, knowledge of healthcare IS interoperability, security and the ambitions of the doctrine of digital health is a prerequisite.

The questionnaires can then be read in groups. Based on the completion of an initial product, the reading of the questionnaires enables the identification of subjects that have been mastered, as well as those that require further investigation.

The pilot can then propose regular meetings with all product managers to monitor the progress of data entry, guarantee the consistency of responses and share expert feedback. 

There are two main user profiles on the Convergence platform:

• Manager: this is either the Corporate Officer or a person authorized by the Corporate Officer; he/she is authorized to add new contributors, create products and grant rights to contributors from his/her company;
• Contributor: authorized to create accounts for other contributors, create products and complete questionnaires, within the limits of the rights assigned to him/her.

Contributors are given access rights to questionnaires for products already created within the platform, and to questionnaires relating to global strategy.

Contributors who do not have the right to validate questionnaires can only save drafts for questionnaires to which they have access. 

The ANS offers 4 types of software certificates:

• Legal person (Organisation)
• Legal person (Server)
• Natural person (Professional)
• Natural person (Health Professional)

This midware allows the interfacing between computer applications, such as the Vivoptim doctors portal and the CPS card.

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.

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).