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Clinical Sign-off Governance

The process by which clinical content gates a Curaway production rollout, and who is accountable for it.

Two different clinical-review processes

This page documents the pre-rollout sign-off gate — a one-time clinical approval that blocks a release. It is not the same as the ongoing per-case Clinical Advisor Review Guide, which is how Dr. Naidu corrects the AI's EHR extractions case-by-case to improve accuracy over time. One is a release gate; the other is continuous operational QA.

Why a clinical gate exists

Curaway routes patients toward elective surgical travel. The platform makes statements with clinical weight — which documents a procedure requires, which findings should pause a case, which ICD/CPT codes attach to a procedure, what counts as a contraindication. The engineering team does not self-author these clinical thresholds. They are authored or confirmed by a qualified clinician before they reach patients.

This is the governing principle of clinical sign-off:

Disposition rule (deferred authoring): Engineering does not invent clinical thresholds, codes, or safety rules. Each clinical item is logged as a finding, and the fix is authored after the clinical advisor provides the number/confirmation — or, for already-built changes, before the built PR merges.

Roles

Role Person Accountability
Clinical Advisor Dr. Shrikanth Naidu Confirms or supplies every clinical threshold, code, screening-panel requirement, and safety-gating rule before it ships.
Data / product owner SD (Srikanth Donthi) Owns the rollout decision; gives the merge nod once clinical sign-off lands.
Engineering — Builds the machinery, logs clinical findings, defers authoring, applies the clinician's numbers.

The v6.2 canary gates

The v6.2-flexible operational canary (ADR-0030) is gated on two clinical-governance items:

Gate Status Tracking
(a) Clinical sign-off OPEN — the sole remaining clinical blocker #1376
(b) Price policy CLEARED — governed indicative ranges decided; runtime price-guard shipped (#1374); duplicate hardcoded cost numbers single-sourced (#1375) Price Governance

Gate (a): the clinical sign-off checklist

Issue #1376 is the single tracking issue for Dr. Naidu's sign-off. It consolidates every [NAIDU]-tagged item surfaced across the Category-A clinical-config work and the synthetic-data sweep, organized into six themed sections:

Section Concern
A. ICD-10 / CPT coding accuracy Billable-code corrections, contraindication reclassifications, laterality defaults
B. Pre-op screening-panel completeness Mandatory vs conditional screening (viral panels, LFTs, dental clearance)
C. Validity windows & numeric thresholds Crossmatch/coagulation max-age, peri-op HbA1c/INR cutoffs, abnormal thresholds
D. Safety-gating rules Per-SOP clinical_safety_rules — the largest patient-facing item
E. Agent clinical-voice boundaries What the agent may/may not say about candidacy, indication, severity
F. Clinical plausibility & device sign-offs Fixture realism, implant-lifespan figures, robotic pre-op field sets

Each box is tagged [BUILT] (fix implemented, waiting only on sign-off), [DEFERRED] (finding logged, fix authored after Naidu input), or [+ENG] / [+DECISION] (also needs a non-clinical step).

Why Section D is the critical gate

All 18 procedure SOPs currently ship clinical_safety_rules: []. The gating machinery is wired but fed nothing — no uploaded red flag can pause the elective-travel funnel until those rules are populated. Populating them requires Dr. Naidu's thresholds (cauda equina, cervical myelopathy / cord-compression, open-fracture / compartment-syndrome). Until then, v6_sop_enabled and the v6.2 canary stay OFF. This is the single highest-leverage clinical sign-off item: it is what turns the safety machinery from wired-but-inert into actually protective.

Sign-off workflow

Finding logged (sweep / audit / case review)
  └─ tagged [NAIDU], added to #1376 with disposition (BUILT / DEFERRED)
       └─ Dr. Naidu confirms number / supplies threshold
            ├─ BUILT item  → SD gives merge nod → PR merges
            └─ DEFERRED item → engineering authors fix with the clinician's number → PR → merge
                 └─ all #1376 boxes closed → gate (a) clears → canary may proceed

The fastest win on #1376 is #1364 (Category-A clinical config) — a complete, dual-reviewed PR that merges the moment Naidu confirms the 10 ICD code corrections + 3 contraindication reclassifications (Section A) and SD gives the merge nod.

Provenance & data handling

  • The findings feeding #1376 came from the synthetic-data end-to-end sweep.
  • Anonymized-production patient transcripts (frt_001–004) used internally during the sweep remained internal-only and were never sent to any external model, regardless of any "synthetic" labelling.