About ClarityCheck
ClarityCheck is an open-source, client-side digital screening tool designed to help adults (18+) who suspect they may have Attention-Deficit/Hyperactivity Disorder (ADHD) prepare for a structured clinical consultation.
The software administers a fixed battery of three clinically validated psychometric instruments, automatically calculates standardized scores, and provides plain-language interpretations to facilitate informed clinical discussions.
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1. ASRS v1.1 Part A (ADHD Screening)
6-item symptom checklist developed with Harvard Medical School and WHO. Evaluates inattention and hyperactivity/impulsivity over the past 6 months against validated shaded-zone cut-offs (≥4 positive items).
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2. PHQ-9 (Depression Screening)
9-item validated assessment scoring depressive symptoms (0–27) over the past 2 weeks across standard clinical severity bands (Minimal, Mild, Moderate, Moderately Severe, Severe).
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3. GAD-7 (Anxiety Screening)
7-item assessment evaluating generalized anxiety symptoms (0–21) over the past 2 weeks across severity classifications.
Automated Crisis Safeguard Pathway (RC-09, RC-11)
In accordance with medical software safety specifications (IEC 62304 Class B), if a user indicates any self-harm ideation on PHQ-9 Item 9 (score ≥ 1), the application immediately activates a prioritized crisis intervention screen with verified helpline contacts before results can be accessed.
Technical Architecture & Privacy by Design
ClarityCheck is engineered in C++17 and Qt Quick (QML), compiled directly to WebAssembly (Wasm) for browser execution.
🔒 Zero Data Transmission: No personal health data, responses, or scores leave your browser. Session data exists solely in transient browser memory and is discarded immediately when the tab is closed.
Regulatory Status & Quality Documentation
This repository contains both the software implementation and complete Quality Management System (QMS) documentation structured under EU MDR 2017/745 (Class IIa SaMD) and ISO 13485:2016.
Current Phase: Research Prototype. The regulatory technical file, risk management file (ISO 14971), clinical evaluation (MEDDEV 2.7/1 rev 4), and usability engineering (IEC 62366-1) documentation are being drafted. Formal CE marking and clinical reviewer sign-off are required prior to commercial medical device release.