# EyeHealthIntel — Pilot Protocol TEMPLATE

> **TEMPLATE ONLY — NOT APPROVED FOR USE.** This document must be completed, reviewed and approved by the
> partner's clinical lead, a data protection officer, legal counsel and — where applicable — an ethics
> committee and the competent authority **before any real patient is involved**. EyeHealthIntel is not
> CE-marked, has no MDR/FDA clearance and releases no diagnostic models. All analyses return NOT_ASSESSABLE.

## 1. Parties and roles
- Sponsor / controller: ______  · Processor: Ravolution AB (org.nr 556709-7547) · Clinical lead: ______
- Data processing agreement reference: ______ (required before go-live)

## 2. Goals (non-diagnostic)
- Measure feasibility of guided, remote eye **image capture** in the partner's workflow.
- Measure image quality and completion — **not** diagnostic accuracy.

## 3. Metrics
| Metric | Definition | Target (to agree) |
|---|---|---|
| Completion rate | sessions completed / sessions requested | ___ |
| First-pass capture success | eyes accepted without retry / eyes captured | ___ |
| Retries per eye | mean retries | ___ |
| Time to complete | request → both eyes | ___ |
| API latency | p50 / p95 ms | ___ |
| Clinician utility | structured survey (Likert 1–5): "image usable for my own assessment" | ___ |

## 4. Population and setting
Inclusion / exclusion: ______ · Expected n: ______ · Sites: ______

## 5. Data handling
- Data region: EU. Opaque external patient identifiers only — no names or national IDs sent to EyeHealthIntel.
- Originals are immutable and SHA-256 fingerprinted; access is audited; tenant isolation enforced in the database.
- Retention: ______ (per tenant retention policy) · Deletion procedure: ______
- DPIA reference: ______ (technical template in `docs/security/operations.md`; legal approval required)

## 6. Safety
- Images are reviewed only by the partner's qualified clinicians under their own clinical responsibility.
- No output from EyeHealthIntel may be used as a diagnosis or triage decision.
- Adverse event / incident reporting path: ______ · Incident severities SEV1–SEV4 per EyeHealthIntel runbook.
- Stop criteria: ______

## 7. Approvals (all required before start)
- [ ] Clinical lead  - [ ] DPO  - [ ] Legal  - [ ] Ethics committee (if applicable)  - [ ] Regulatory assessment
- [ ] Signed DPA  - [ ] Security review  - [ ] Patient information & consent text approved