Why this page exists: Under the EU AI Act (Art. 13) and GDPR (Art. 22), automated systems must provide complete explainability. This page shows the mathematical decomposition of feature attributions for each score, demonstrating that the AI operates deterministically while respecting the MDR Rule 11 wellness firewall.
How to use this for your Kidney Trial:
Show Johnny the **MDR Rule 11 Scope Firewall** box. This is his legal shield, proving the tool acts as a wellness measurement utility, not a medical diagnostic device.
Toggle the **Session Selector** buttons (`T-0`, `T-Mid`, `T-End`) to show how feature attributions shift over time as the patient recovers.
Point to the **Attribution Bars** to show how specific features (e.g. posterior tongue coating ratio or 6:00 sector lacuna depth) mathematically construct the score.
Review the **Full Feature Traceability Matrix** showing raw inputs, processing methods, and validation status.
💡 Use this report to satisfy ethics boards or scientific review panels demanding AI explainability.➡️ Next Step: DPIA & Legal Docs →
Vera XAI Explanation Report
Deterministic measurement traceability · EU AI Act Art.13 transparency · MDR Rule 11 scope firewall · VS-3
Vera Clinical measurement tools are wellness measurement utilities, not medical diagnostic devices. No output from VeraTongue, VeraIris, VeraVox, VeraCordis, or VeraFocus constitutes, implies, or suggests a clinical diagnosis, prognosis, or therapeutic recommendation. All clinical assessment, interpretation, diagnostic reasoning, and therapeutic decision-making is the sole and exclusive responsibility of the licensed practitioner (Dr. Johannes K., M.D.).
This XAI report documents which input features contributed to each computed score — it does not interpret those scores as health outcomes. Feature contributions are provided for scientific transparency and audit purposes only, pursuant to EU AI Act Art. 13 (Transparency obligations for high-risk AI systems) and GDPR Art. 22 (Automated decision-making safeguards).
NOT a Medical DeviceEU AI Act Art.13 ✓GDPR Art.22 ✓MDR Rule 11 — Wellness Scope ✓XAI Deterministic ✓
Session:
📋 Full Feature Traceability Matrix
Instrument
Input Feature
Raw Value
Processing Method
Output Parameter
Contribution %
ZKP Committed
🏛️ Regulatory Scope Taxonomy — What Vera Measures vs. What It Does NOT Do
✅
DOES: Captures and quantifies physiological parameters (acoustic frequencies, pixel intensity distributions, PPG inter-beat intervals) using deterministic digital signal processing. Commits parameters to a ZKP Merkle Tree for tamper-evidence. Displays values for practitioner review.
❌
DOES NOT: Diagnose any disease or condition. Recommend treatment, medication, or intervention. Provide prognosis. Generate clinical decision support output. Classify patients into diagnostic categories. None of the above are functions of the Vera platform.
⚖️
LEGAL BASIS: EU MDR 2017/745 Annex VIII Rule 11 applies to software "intended to provide information which is used to take decisions with diagnosis or therapeutic purposes." Vera's intended purpose is measurement and data capture only. Clinical interpretation is exclusively a human practitioner function. Vera therefore falls outside MDR medical device scope and requires no Notified Body conformity assessment.
🔐 ZKP Commitment Proof
Every parameter in this report was hashed and committed to the Vera Merkle Tree before analysis. The following commitment hashes prove data integrity — any post-hoc modification would invalidate the hash.