Regulatory-Ready Digital Twins for Patient-Centred Mental Health Technologies

Mential proposes a regulatory science framework based on clinically structured Digital Twins for mental health. The platform continuously transforms multimodal patient data (text, voice, behaviour, questionnaires) into structured FHIR markers, enabling real-world evidence generation aligned with MDR and the EU AI Act.

Concrete activities include:

• Designing regulatory-grade digital endpoints for mental health outcomes.

• Running longitudinal validation studies comparing Digital Twin–derived markers with traditional clinical scales.

• Developing explainable AI logs, audit trails and post-market surveillance models.

• Piloting regulatory sandboxes with hospitals, insurers and regulators.

What makes Mential different is its FHIR-native architecture and continuous monitoring model. Unlike episodic studies or static DTx tools, Mential provides traceable, explainable and continuously updated clinical evidence, making it uniquely suited to regulatory science and translational validation.