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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 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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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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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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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.
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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.
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There are several levels of requirements for a module’s integration into the Hospital Information System.
The main requirements set out by the referential are:
- Interfacing, control, security guidelines;
- Prescription process requirements;
- National prescription thesaurus integration requirements;
- Requirements regarding medico-economic and decision processes;
- Guidelines for ergonomics, functions, and notification alerts;
- Settings function requirements.
In total, 139 requirements are used to reach the minimal level of security needed for a solution’s integration into the hospital information system.
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The current referential (2017) was written with industry experts. It introduces the particular context of this mission and the goals to reach in order to improve safety measures in neonatology and paediatric reanimation. The referential walks you through the fundamental concepts you need to grasp to understand the several requirements and protocols involved with software development for this sector.
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Neonatology is a high-risk practice for two main reasons:
- The patients are extremely fragile (premature babies)
- 50% of the drugs used in the sector have yet to receive a marketing authorisation.
A survey conducted in 2014 evidenced a risk in the prescription process across the sector. The digitalisation of prescription is among the 41 recommendations that the report issued in order to increase safety levels.
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