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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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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 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 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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These documents are made available by the CNDA as a .zip file below.
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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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Your level of access to the ROR data depends on the nature of the data you wish to use (public/restricted) and the perimeter you wish to cover (one ROR or several ROR directories).
The ROR data in public access:
- is available as opendata since mid-2022;
- will be available directly on the national ROR with no specific procedure in early 2023.
The ROR data in restricted access (professional access):
- for one regional ROR, you must complete a request form to join the regional circle of trust and send it to the region’s GRADeS;
- for several ROR directories, you must complete a request form to join the national circle of trust and send it to the ROR program team.
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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 application for the SI-MDPH label is open to any legal entity with a software solution aimed at the departmental disability centres (MDPHs). This includes the MDPHs themselves, which develop their own solutions in conjunction with the relevant Departmental Council.
The label application is a voluntary process: Anyone can be a candidate if they feel that their solution complies with the current requirements and the scope of the sector’s functional standards.
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PLATINES is a platform dedicated to interoperability tests for eHealth. It stimulates a ROR (version 2.4) and gives you the opportunity to use “test” data via several professional cases (a total of 94 test scenarios are available). These test scenarios are valid for the current ROR as well as the national ROR.
You must contact the ROR program team to request access to PLATINES.
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