Technical checks completed
- Golden, completeness, and determinism tests for protocol packs at CI time.
- Safety-language gates on assistive-only protocol output text.
- OpenAPI generation and strict schema validation on API contracts.
Validation roadmap
OrthoSphere on pendarlink.com is a medical AI prototype lab and academic validation platform. This roadmap explains what has been checked technically, what remains open clinically, and what must happen before any operational deployment.
Prototype portalSynthetic demo onlyValidation in progressGovernance required
Current stage
Stage 1 · current stage
Synthetic prototype demonstration
Public portal and controlled demos use synthetic or de-identified scenarios only. Technical rule checks run in CI; outputs remain assistive-only and require clinician review.
Stage 2 · next
Governance review and pilot scoping
Institutions review validation posture, safety doctrine, data-handling constraints, and authority boundaries before any expanded pilot beyond demonstration.
Stage 3
Expanded technical and human-factors validation
Structured usability review, golden-test expansion, publications, and institutional pilots under governance — not implied by current prototype availability.
Stage 4
Governed pilot readiness
Any real-world institutional use requires completed validation, local governance approval, data-protection review, and clinician oversight.
Evidence and readiness expectations
Clinical and operational gaps
- No completed prospective trial of patient-outcome impact.
- No formal human-factors validation in live care settings.
- No regulatory clearance (e.g. FDA 510(k), CE marking).
Before clinical deployment
- Institutional governance approval and data-handling review.
- Expanded validation evidence and human-factors evaluation.
- Explicit authority-boundary review for each enabled surface.
Service authority summary
| Surface | Role | Authority boundary |
|---|---|---|
| OrthoPath | Deterministic CDS prototype | Only OrthoPath may emit clinical recommendation objects; clinician review required. |
| OrthoRAG / Evidence Copilot | Explain-only evidence retrieval | Must not emit recommendations or clinical decide language. |
| Registries / workflow / monitoring / pilot / search | Workspace and visibility prototypes | Not independent CDS lanes; no autonomous orders or treatment decisions. |
Full validation documentation (Trust Dossier) · Discuss institutional collaboration · Trust & Safety · Contact & governance