French Public Health Code
In forceA 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 services that have received a favourable opinion from the commission may be referenced in the digital health space catalogue by decision of the Minister responsible for health.
The referencing of a digital tool or service gives rise, prior to its implementation in any digital health space, to the signing of an agreement between the publisher of the service or tool, the Minister responsible for health and the Caisse nationale de l'assurance maladie. In particular, this agreement defines the respective responsibilities of the parties, the categories of data to which the service or tool may have access with the consent of the holder, the duration of the referencing, and the procedures for its possible withdrawal.
An audit procedure for referenced digital services and tools, defined by order of the Minister for Health, guarantees their compliance over time with the elements contained in the initial referencing request.
