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.

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”

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.

There are two steps to follow:

Step 1: Administrative phase

Should you wish to order test CPS cards or register authorisations for test software, you may:

• read our complete products offer ;
• place an order
  To place an order, select your Profile and your Structure, then choose “Produits de développement. Commander des produits de développement : carte et/ou certificat logiciel de test" (Test products for products, cards and/or test software).

Step 2: Technical phase

Use the card you validated after step 1 in order to connect with the Trusted Platform IGC-Santé. You will be able to order, withdraw, monitor and revoke test certificates through the IHM or Webservice interface.
In order to do so, make sur you have inserted your test card in the card reader. 

Read more about specific setup guidelines:

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.

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:

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.

To register on the Convergence platform, you need to download the account request form to open an account as a company representative. 
Before completing this form, please check that your company is not already represented by another person who is able to create an account for you to access the Platform. If you have any questions, please contact support at ans-support-convergence@esante.gouv.fr. 
As soon as you receive the e-mail confirming the creation of your account, you will be able to initialize your password and access the Platform after accepting the General Terms of Use.

There are 6 types of activities that make you eligible as a health data host:

1. providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
2. providing and maintaining the structural material used by the IS to host health data;
3. providing and maintaining a platform that hosts the IS applications;
4. providing and maintaining a digital structure for the IS which hosts health data;
5. the administration and exploitation of the IS which contains the health data;
6. health data backup services.

The full list of HDS-certified activities is available here: 

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. 

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 

All the resources for funding are available in our Ségur section for digital equipment.

These documents are made available by the CNDA as a .zip file below.

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.

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:

To make sure your software complies with the guidelines required to implement INS into software, several documents are available:

For your application to be complete, you need to include several credentials and documents.

The list of documents and credentials needed is detailed in the Application form (download it below). You will need to send and application for each product you wish to label.

You must return your application form with all the supporting material by email AND via postal services:

1. the complete application form needs to be sent by mail to:

   Agence du numérique en santé (ANS)
   Labellisation logiciel Maisons et Centres de Santé
   9, rue Georges Pitard
   75015 Paris

2. follow up with sending digital versions (PDF scans) of the agreement and its annexes, in two copies, signed and completed to:

   labellisation.msp@esante.gouv.fr

The IGC-Santé is dedicated to the health sector and follows strict procedures in terms of data collection, professional identification, and works with certified authorities (RPPS register, etc.).

The certificates issued by the IGC guarantee the security of software or electronic cards, such as the CPS card.

The IGC also manages the publication of these certificates and can revoke them – this is signalled to the apps using certificates in revocation listings.

There are two main reasons for the creation of IGC-Santé :

• guaranteeing the security of private keys and certificates issued by the ANS: the access to these private keys must be limited in order to prevent duplicates or their installation more than one device;
• maintaining a continuity in services: many health apps used to work on certificates issued by former CKI that ceased their activity in January 2021. These apps must be compatible with certificates issued by the IGC-Santé.

In addition, these certificates meet the security standards (risk analysis, safety policies), or “Certifying Policies” that comply with the PGSS-IS guidelines.

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.