Industrials FAQ

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

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.

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 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.

Le Centre de Gestion des Terminologies de Santé a donc pour mission de se charger de cette maîtrise d’ouvrage opérationnelle des ressources sémantiques, mais aussi du guichet national de publication, ainsi que de l’accompagnement des utilisateurs. En France, le CGTS regroupe à date au sein de son catalogue 34 Terminologies couvrant un grand nombre de domaines médicaux.

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.

The list of connected services is available online.

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:

The open access data is free to download. However, the user must be mindful of the General Conditions when working with the Health Pro Directory information.

There are two search options in the Health Pro Directory:

• A keyword search (Who ? What ? Where ?) that allows you to find professionals in matching establishments;
• A detailed search (Profession, specialisation, skills, ID, place of practice) to target health professionals or health structures.

The service is only available for foreign patients that meet the following criteria:

• the patient must come from an EU country providing the Sesali service;
• the patient must have activated the service (depending on their country);
• the patient must have a medical summary in file in their country’s systems.

The list of eligible nationalities is available on the Sesali.fr homepage.

Guarantees are set out on the dedicated page.

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

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.

The RPPS has restricted access content. You need to log in to the Health Pro Directory to access these data. The use of a CPS card as means of authentication is required:

• if you carry a Director of Establishement (CDE) card or a liberal CPS card, you may automatically access the information whose access is granted to you;
• in other cases, accessing the directory with a CPx-type card may need a prior enrolment process with the ANS. You will need to fill a RPPS access request form.

You need a card reader in order to authentify yourself with a CPx-type card.

For further information, read our pages to the CPS and e-CPS.

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.

In order to request test products for certificates (CPS cards and test software certificates) issued by the IGC-Santé, go to our service page for the IGC-Santé.