Section 4: Digital health space

Digital health services and tools developed by publishers of public or private digital solutions may be referenced in the digital health space catalogue provided that they comply with: 1° The interoperability and security reference frameworks mentioned in article L. 1470-5; 2° The ethical commitment reference frameworks defined by order of the Minister for Health. The Minister for Health may, by order, set other criteria relating to the quality of digital…

A commission for listing digital services and tools in the digital health space service catalogue is created. An order by the Minister for Health shall establish its composition and specify its operating procedures. This commission examines requests for inclusion in the digital health space service catalogue in accordance with the criteria set out in article R. 1111-37 and gives its opinion to the Minister for Health. Only digital tools and…

The members of the commission for referencing digital services and tools in the digital health space service catalogue mentioned in article R. 1111-38, with the exception of ex officio members, may receive an allowance allocated for their effective participation in the commission’s meetings. The amount of this allowance is set by joint order of the Minister for Health and the Minister for the Budget.

The application for registration is made online using a service provided by the Caisse nationale de l’assurance maladie. The application for registration includes the response to a questionnaire assessing whether the applicant meets the criteria set out in Article R. 1111-37, the data protection impact assessment provided for in Article 35 of Regulation (EU) 2016/679 on the protection of individuals with regard to the processing of personal data and on…