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 ?
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.
Cette réponse vous a-t-elle été utile ?
Health CERT operates on weekdays between 9am and 6pm. Aside from these working hours, it is possible to contact the ANSSI to signal risks.
CERT Santé
+33 (0)9 72 43 91 25
Agence du Numérique en Santé
9 rue George Pitard, 75015 Paris
Cette réponse vous a-t-elle été utile ?
Yes. The ANS has a video platform with training material, including cybersecurity support. You will find information about cybersuveillance auditing, how to signal a security risk, how to increase your password security, and how to identity malicious email.
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 ?
Healthcare industrials and software publishers are encouraged to contact Health CERT if they discover a security incident or potential malware. CERT provides assistance and support to resolve such issues. CERT also assists you in your communications to health structures.
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 ?
In order for your service to be referenced in the My Health Space database, it must comply with the eHealth doctrine.
The doctrine is re-edited each year and defines the base rules of good practice for security, interoperability, and ethics applicable to eHealth services.
Cette réponse vous a-t-elle été utile ?
My Health Space includes the following health data:
- The medical profile entered by the patient, in an unstructured format (preconditions, allergies);
- Health measurements (weight, height, BMI, temperature, waist size, heart rate, blood pressure, glycemic index, level of pain) in FHIR format;
- Health documents (for example: test and diagnosis results, hospitalisation reports, medical treatments).
Cette réponse vous a-t-elle été utile ?