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.

There are 6 types of activities that make you eligible as a health data host:

1. providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
2. providing and maintaining the structural material used by the IS to host health data;
3. providing and maintaining a platform that hosts the IS applications;
4. providing and maintaining a digital structure for the IS which hosts health data;
5. the administration and exploitation of the IS which contains the health data;
6. health data backup services.

The full list of HDS-certified activities is available here: 

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.

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.

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”

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.

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.

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:

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.

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. 

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 

All the resources for funding are available in our Ségur section for digital equipment.

These documents are made available by the CNDA as a .zip file below.

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: 

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.

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:

1. 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

2. follow up with sending digital versions (PDF scans) of the agreement and its annexes, in two copies, signed and completed to:

   labellisation.msp@esante.gouv.fr

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.).

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.

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.

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).