Adult ADHD Digital Biomarker Feasibility Assessment: Charité Universitätsmedizin Berlin

There is no validated digital endpoint for adult ADHD in Europe. This document is a Phase II site feasibility assessment for a digital biomarker-aided diagnostic protocol at Charité Universitätsmedizin Berlin, targeting adult women with suspected or unrecognised ADHD and West African heritage. The proposed battery spans three evidence tiers: actigraphy and rest-activity rhythm (established, adult validation gap), continuous performance testing (validated, existing Charité infrastructure), and smartphone passive monitoring (novel, pilot-stage with large effect sizes). The framework includes community-anchored site feasibility, GDPR Article 9 privacy-by-design architecture, and EU MDR Class IIa regulatory pathway analysis.