Method
Clinical AI Validation Gate
Maps clinical AI intended use, validation evidence, subgroup performance and workflow controls into a gap report.
Field scoring contract
| Field | Type | Role | Direction | Scored |
|---|---|---|---|---|
| Intended use | text | context | context | no |
| Patient population | text | context | context | no |
| Ground truth quality | select | evidence_signal | higher_is_better | yes |
| Calibration evidence | select | evidence_signal | higher_is_better | yes |
| Subgroup evidence | select | evidence_signal | higher_is_better | yes |
| External validation | select | evidence_signal | higher_is_better | yes |
| Prospective validation | select | evidence_signal | higher_is_better | yes |
| Monitoring plan | select | evidence_signal | higher_is_better | yes |
| Human oversight | select | evidence_signal | higher_is_better | yes |
| Cyber/privacy controls | select | evidence_signal | higher_is_better | yes |
| Clinical endpoint | text | context | context | no |
| Reference standard | text | context | context | no |
| Human factors evidence | select | evidence_signal | higher_is_better | yes |
| Model version and change-control evidence | select | evidence_signal | higher_is_better | yes |
| Harm/error-case model | select | evidence_signal | higher_is_better | yes |
| Regulatory status evidence | select | evidence_signal | higher_is_better | yes |
Limits
- Preliminary output
- Human review required
- Not certification
- Domain-specific checks added; not certification
- Context text is not averaged into numeric scores.
- Outputs require source/evidence review before decisions.