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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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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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To make sure your software complies with the guidelines required to implement INS into software, several documents are available:
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Le Centre de Gestion des Terminologies de Santé a donc pour mission de se charger de cette maîtrise d’ouvrage opérationnelle des ressources sémantiques, mais aussi du guichet national de publication, ainsi que de l’accompagnement des utilisateurs. En France, le CGTS regroupe à date au sein de son catalogue 34 Terminologies couvrant un grand nombre de domaines médicaux.
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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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Health professionals are encouraged to use MOS and NOS for three main reasons :
- enhance the interoperability of information systems by harmonising names, attributes, codes and nomenclatures;
- share the same understanding of the information, regardless of which directory or reference document it is taken from;
- facilitate the specification, analysis and conception of a project.
The ANS offers training on MOS-NOS and the elaboration method for exchanges’ functional specs (see our Documentation section).
The illustration below gives you examples of the types of professionals using the MOS-NOS:
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A terminology is an ensemble of concepts defined by terms which belong to a specific language set.
Terminologies are defined through a research process aimed at finding the most relevant terms used by a specific profession (or a field of expertise) in a particular context of use.
Centralising and monitoring this vocabulary is essential to maintain a coherent use of the terms amongst eHealth experts and healthcare professionals.
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Our partner, the GIE Sesam-Vitale, is here to provide you with support and answer your questions about your software project, how to integrate INSi, or solve any potential technical setbacks.
The helpdesk is available by phone at +33 (0)2 43 57 42 88, from 9am to 12noon, and from 2pm to 6pm, Monday to Friday. You may also send an email to centre-de-service@sesam-vitale.fr.
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In order to make the check lists more transparent and reduce the risk of seeing your Ségur application denied, we have published a document listing common mistakes, which is available below:
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The MOS is a collection of concepts described homogeneously and neutrally in terms of technologies. It offers a common description of the information processed and exchanged in the information systems to make digital communication easier.
The overall consistency of the MOS is founded on the definition and description of its UML (Unified Modelling Language) concepts.
Some MOS concepts can be coded. They are associated with the nomenclatures of health objects (NOS), i.e. lists of codes/labels.
You are encouraged to use MOS and NOS to :
- optimise and coordinate efforts when you analyse or conceive a system (or an application) by re-using the same semantic components;
- make sure there is consistency in your internal developments and with external systems, for the best possible interoperability.
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The digital transition in France involves much more health data transfers. It is essential to set up a common language in this ecosystem, which currently lacks homogeneity at a local and international scale. The CGTS was created by the State to centralise the semantic resources for health professionals.
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The European Commission’s studies have determined there is a need for a base vocabulary, such as MOS and NOS, which can be used as a starting point for:
- develop and evolve information systems (IS) to formalise the conceptual and logical data they utilise (for instance, the MOS is a reference for the modelling of the RPPS);
- share information between ISs to create specific models of data they can use (thus, the MOS is underlying the ROR exposure model);
- combine and synthetise elements originating from different sources;
- publish data in a common format, such as a directory or catalogue of service (for example, the Annuaire Santé / Health Pro Directory).
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Upgrading your products allows you to offer your customers a solution that complies with current regulations. Failure to meet this requirement will have several impacts:
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Your customers will not incorporate the INS into their software, which will entail possible penalties with regard to several systems (Ségur Wave 1, HOPEN, portal listing in Mon Espace Santé, etc.) ;
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Your customers will not be in compliance with the law. They will therefore be responsible for any errors in the identification of their patients and users ;
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Sharing health data by your customers will be more time consuming ;
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The identity used by your customers may not be the right one, for instance if a patient uses their married name or if the patient is a child registered under their parent’s social security number.
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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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