Encephale. 2026 Sep 19:S0013-7006(26)00174-0. doi: 10.1016/j.encep.2026.07.004. Online ahead of print.
ABSTRACT
BACKGROUND: As traditional biomarkers have failed to deliver on promises of personalized diagnosis and treatment in psychiatry, digital biomarkers offer continuous and ecologically valid monitoring. By capturing symptoms directly within patients' everyday environments, they support a systemic approach to psychiatry. However, this ecological dimension challenges conventional validation criteria and requires in situ validation beyond research laboratories.
OBJECTIVES: This study has two aims: first, to identify and compare standardization documents that could support validation standards for digital biomarkers in psychiatry; second, to situate these documents within a circulation framework between laboratories and the real world, inspired by the sociology of innovation, in order to analyze their dynamics. Methods Standardization documents relating to the validation of digital biomarkers and smartphone applications in psychiatry were identified through expert selection. Their main dimensions were extracted and mapped onto a framework linking laboratories and the "wider world". This process was conducted by an interdisciplinary consortium combining computer science, psychiatry, and Science and Technology Studies (STS).
RESULTS: Four heterogeneous standardization documents were identified. Mapping their components within the circulation framework enabled comparison of the documents and of the design constraints they implement.
DISCUSSION: The findings suggest that these standardization documents are not yet stabilized. Rather than fixed standards, they function as tools for negotiation between epistemic communities and actors with unequal power relations, within academic infrastructures that maintain biases. This highlights the need for a socio-technical democracy in mental health.
CONCLUSION: STS provides valuable tools for understanding the dynamics of standardization and the plurality of actors involved in validating digital biomarkers in psychiatry.
PMID:42763255 | DOI:10.1016/j.encep.2026.07.004