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 ?
To make sure your software complies with the guidelines required to implement INS into software, several documents are available:
Cette réponse vous a-t-elle été utile ?
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.
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 ?
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.
Cette réponse vous a-t-elle été utile ?
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:
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 ?
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:
-
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.) ;
-
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 ;
-
Sharing health data by your customers will be more time consuming ;
-
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.
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 ?
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 ?