Define before designing the interface
- Population, treatment and observation period.
- Clinical question and rationale for every measure.
- Device, ePRO instrument and minimum dataset.
- Threshold, priority, response hours and pathway owner.
- Endpoints, analysis plan and stopping criteria.
Separate validation levels
Technical validation asks whether data transfer correctly. Analytical validation asks whether the feature is reliable. Clinical validation asks whether it relates to a state or outcome and improves a pathway. Passing one level does not prove the next.
Participant and data protection
Before real collection, the project needs ethics and regulatory review, a threat model, contractual roles, informed consent, a lawful basis for health data and an incident-response plan. The public site remains informational only.