Votre question concerne quel type d'offre ?
Votre question concerne quel couloir Ségur ?
Votre question concerne quel dispositif Ségur ?
Votre question concerne quel produit ou service produit?
Votre question concerne quelle thématique ?
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”
Cette réponse vous a-t-elle été utile ?
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:
Cette réponse vous a-t-elle été utile ?
It is compulsory to have an individual CPx-type card to log in to the INSi teleservice. Three types of cards are supported: CPS, CPE, CPF.
Cette réponse vous a-t-elle été utile ?
CPx cards issued before December 2020 have a contactless chip that prevents from overwriting its code.
The new CPS R3V3 cards that are now in circulation have a Mifare Desfire chip. These cards can stock crypto-secret keys that work with the Mifare Desfire protocol.
All the information about this feature is available in the Manual to deploy contactless CPx cards (available to download below). One must be cautious about the data inserted in the chip’s writing code.
We strongly advise against using this section of the chip to stock access rights. The ANS recommends you to use the ANSSI guidelines on using a "transparent" reader in connected mode. This does not involve a cryptographic protocol during a badge authentication – only the UTL (logic treatment unit) takes part in the cryptographic protocol.
ANSSI advises against setting up a “smart” badge allowing a double authentication breaking from the UTL.
All the recommendations on securing systems for physical access and video projection are available in the document below, "Recommendations on securing systems for physical and video projection access".
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
No, a person may only have one e-CPS card at a time.
Cette réponse vous a-t-elle été utile ?
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.
Cette réponse vous a-t-elle été utile ?
This midware allows the interfacing between computer applications, such as the Vivoptim doctors portal and the CPS card.
Cette réponse vous a-t-elle été utile ?