National Digital Health Challenge in mental health

Pourquoi un Grand Défi Numérique en santé mentale ?

Les troubles psychiques constituent un enjeu majeur de santé publique : 1 personne sur 4 sera concernée au cours de sa vie et figurent parmi les principales causes de handicap dans le monde, selon l’OMS. On constate une hausse des conduites addictives, suicidaires et anxio-dépressives, notamment, chez les jeunes. Dans ce contexte, la santé mentale a été ré-affirmée comme Grande Cause Nationale pour 2025 par le Premier Ministre.

Le numérique propose des aides pour apporter une partie des réponses adaptées à ces enjeux. Ces outils ne remplacent pas les interactions humaines, mais viennent en synergie avec les soins existants, pour renforcer la relation soignant-soigné et améliorer l’accès à la prévention et aux soins, afin de contribuer à l’autonomisation individuelle et collective. 

Le Grand Défi Numérique " Dispositifs médicaux numériques au service de la santé mentale" vise à accélérer et faciliter l’accompagnement des porteurs de projets et des utilisateurs de solutions numériques en santé mentale et en psychiatrie. 

How does the National Digital Health Challenge support digital innovators in mental health?

The actions of this National Digital Health Challenge have been co-constructed with the mental health digital ecosystem and the Digital Challenge Expert Committee, following a consultation phase during the 1st half of 2024. Four axes were prioritized by the stakeholders.

Axis 1: Helping innovators in the innovation and research stages of digital DM in mental health and psychiatry

October 10, 2024 launch of Stage 1 of the "Grand Défi Numérique DMN au service de la santé mentale" call for projects to support project leaders in the development of digital innovation in mental health:

  • Stage 1: Development of future digital medical devices in mental health, building on previous work with a TRL level higher than 4/5 (technological maturity scale).

Axis 2: Support project leaders to generate evidence and evaluate the benefits of MNDs in mental health and psychiatry

Launch of Stages 2 and 3 of the "Grand Défi Numérique DMN au service de la santé mentale" call for projects to support project leaders in the regulatory validation and evaluation phases of these mental health devices:

  • Stage 2: Clinical evaluation with a view to obtaining CE marking for the future DMN.
  • Stage 3: Budget impact analysis (BIA) study of the DMN (post-CE mark) in the envisaged mental health indication.

Axis 3: Work to integrate these MNDs into mental health practice, user adoption and care.

  • Challenge Prevention: digital medical devices are increasingly offering functionalities in the service of mental health prevention. It is in this context that the mental health theme has become one of the 8 priority topics of the Challenge Prevention. The aim is to help innovators demonstrate the real-life value of their innovations.
     
  • Launch of the "Digital Ethics in Mental Health" Working Group under the aegis of the National Digital Health Challenge expert committee : This initiative aims to ensure the responsible and effective use of digital tools in the service of mental health and psychiatry. 
     

Area 4: Raising awareness and training users and professionals

  • Launch of the "Digital training in mental health" working group: integrating new digital health technologies into care and life pathways requires training in the benefits and risks of digital use in mental health. It is in this context that a thematic working group "Digital training in mental health" has been launched from the expert committee of the grand digital challenge in order to structure a cycle of action in the short, medium and long term.

How do you apply to calls for projects and what funding is available when developing a digital mental health solution?

There are programs to support development, evaluation and market access to meet the regulatory constraints of mental health innovators.

CFPs proposed by the Tiers Lieu d'Expérimentation (TLE) en santé numérique dedicated to mental health :

The regulatory diagnosis support program

National Digital Health Challenge Expert Committee

As part of the structuring of the Grand Défi Numérique DM numériques en santé mentale, a committee of experts has been set up in conjunction with the Délégation ministérielle à la santé mentale et à la psychiatrie and the Délégation ministérielle au numérique en santé.

In particular, its missions are to:

- Participate in the structuring of the National Digital Health Challenge

- Participate in the strategic enhancement of the National Digital Health Challenge and related work to involve stakeholders and civil society as much as possible

- Participate in thematic working groups covering the following topics: ethics, evaluation, economic models, training and awareness-raising (general public).

- Contribute to the scientific watch to ensure the relevance of ongoing projects