Ethical and Regulatory Note – Research Demonstrators

• All 5 pilot use-cases.
• All demo projects derived from them.
• All AI-generated outputs (append-only audit trail).
• All exports (PDF, PPTX, ZIP).
• Any presentation to partners, funders, or institutions.

• No diagnosis.
• No prognosis.
• No treatment recommendation.
• No clinical alerting.
• No replacement of screening, follow-up, or clinical decision-making.

HOPE METRIX does not provide diagnosis.
HOPE METRIX does not provide prognosis.
HOPE METRIX does not recommend treatment.
HOPE METRIX does not trigger clinical alerts.
HOPE METRIX does not replace screening, follow-up, or clinical decision-making.

• Intended purpose: research support only.
• Target users: researchers, data scientists, clinician-researchers in non-care contexts.
• Outputs: relative risk indicators, exploratory stratifications, uncertainty-aware research metrics.
• Boundary clarification: the platform does not meet the intended purpose criteria of a medical device under EU MDR or equivalent frameworks.
• This is a boundary clarification only (no claim of compliance, approval, or exemption).

• All models explicitly surface uncertainty; outputs are probabilistic, not deterministic.
• Missing data, bias, and confounding are treated as first-class concepts.
• Absence of evidence ≠ evidence of absence.
• Specific risks: rare-event bias, data imbalance, high-dimensional overfitting, and population shift.

• The platform includes safeguards against clinical misuse.
• Any attempt to interpret outputs for individual patient care is considered misuse.
• The AI Copilot actively flags potential misuse or over-interpretation.
• Any downstream clinical interpretation of the outputs is outside the intended scope and responsibility of HOPE METRIX.

• Demonstrators rely on synthetic or abstracted data; no raw data upload is required.
• No identifiable patient data is exposed in the demonstrators.
• Data minimization and traceability are design principles.
• Any real-world data usage requires appropriate ethical review and governance.

This is the exact research-only disclaimer embedded in all demonstrator exports.

These demonstrator use cases are provided for scientific research and exploration purposes only. They do not constitute medical diagnosis, clinical decision support, or treatment recommendation.