In order to promote access to innovations for citizens, France must invest in new markets and tow innovation to healthcare professionals and citizen-patients.

This action aims to support the maturation of innovative solutions, enabling both the French ecosystem to grow and citizens to benefit from care whose quality is enhanced by digital.

With regard to digital or connected medical devices for therapeutic purposes (providing a therapeutic intervention based on clinical evidence to prevent or treat a disease or medical condition), the following technological areas will be favored in particular:

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• Digital medical devices/software for therapy (including digital therapies);
• Therapeutic connected medical devices;
• Active implantable medical devices with a digital component providing specific clinical value;
• Medical therapy devices including artificial intelligence;
• ...

Digital or connected medical devices for diagnostic or monitoring purposes, without an interventional component, are not covered by this i-Nov theme.

Mental health is one of the areas in which the imbalance between digital need and supply is greatest. We will also be keeping a close eye on the risks of a digital divide. On this theme, the following technological solutions in particular will be expected:

• Applications and connected objects to combat depression, anxiety, insomnia, addictions, eating disorders...
• Therapeutic serious games;
• Using artificial intelligence to predict risky behavior (suicide, violence, etc.);
• Digital simulation technologies for training mental health professionals.

The solutions proposed will have to be in line with the actions under the Mental Health and Psychiatry Roadmap, which were reinforced at the Assises de la Santé Mentale et de la Psychiatrie.