The bioethics law after several revisions was finally adopted in August 2021. In its draft format, Article 11 of this law, which became Article 17 in its final format, introduces a legal framework for medical devices “involving algorithmic data processing that is learned from massive data”, i.e. an artificial intelligence system.

With its adoption, this law introduced a new article in the public health code referring to medical devices with artificial intelligence, article L4001-3. The latter makes a point of transparency in the use of such devices and stipulates that the person concerned by the use of these devices must be informed of the presence of an artificial intelligence algorithm and warned of the resulting interpretation. Still about transparency, professionals using a medical device that includes an AI will have to be informed as well as the access and use of the patient’s data as well as the resulting results.

The designers of these medical devices are also concerned by this new article, they must be able to ensure that the functioning of these devices is explained to users. This point contributes to the introduction of the principle of human guarantee.

Finally, after an opinion from the HAS and the CNIL, a decree (not yet published) will define the nature of the medical devices concerned by all these measures as well as their conditions of use.