PORTAL_ICNORA · PHASE 8B

External production-like qualification

Phase 8B takes the immutable Phase 8A staging release candidate into provider-neutral production-like qualification. External HA/PITR, KMS/HSM, WAF/TLS, SIEM, encrypted storage, disaster recovery and independent penetration evidence must be reviewed. REAL PATIENT DATA LOCKED; Phase 8A staging safeguards remain retained.

REAL PATIENT DATA LOCKED · Surveillance support onlyNo autonomous clinical diagnosis or treatment decision. All visible data are synthetic; VAE production activation is separate from validation evidence, live FHIR/HL7 ingestion remains disabled, and human adjudication remains mandatory.

Identity MADOMIC SSO + vault boundaryTenant Dedicated Alpha DBRules CDC/NHSN · January 2026 · version lockedInterop Synthetic lab onlyBACTIMA Evidence-only bridge

Phase 8B External qualificationPilot NOT AUTHORIZEDNetwork Default deny targetBackup PITR + tenant restore proof requiredSecrets External manager / KMS-HSM

CAUTIGoverned

0.00/1,000 IUC days

Human-confirmed numerator only

CLABSIGoverned

125.00/1,000 line days

Synthetic demonstration rate

VAEGoverned

LABvalidation mode

CDC official SDS gate: NOT RUN

SSIGoverned

1/1confirmed / procedures

Crude demonstration only · no SIR

PHASE 8B EXTERNAL QUALIFICATION

Production-like evidence readiness

Synthetic only

KMS / HSM BoundaryExternal key references only; database key material forbidden. DEV_ENV can never be production approved.

REFERENCE ONLY

VAE Validation LabProduction automation remains disabled until official CDC SDS validation passes.

LOCKED

FHIR/HL7 TRANSACTION LABHash-verified transactional materialization and rollback for synthetic records only; live feeds remain locked.

SYNTHETIC ONLY

Terminology RegistryStores codes, versions and provenance—not licensed terminology content.

MAPPINGS ONLY

SSI PROCEDURE DENOMINATORS

Procedure-linked surveillance

39versioned categories

30 / 90day surveillance periods

A confirmed SSI must link to a validated procedure denominator. Crude observed rates are kept distinct from risk-adjusted SIR methodology.

SYNTH-PROC-COLO-001 Validated denominator

VAE VALIDATION LAB

Algorithm locked behind validation

LOCKED

Official CDC synthetic datasetStatus: NOT RUN

VAC→IVAC→PVAP

Local synthetic cases may exercise the algorithm. No production auto-candidate path is enabled until the official validation dataset matches its expected results.

INTEGRATION LAB

FHIR + HL7 with replay safety

FHIR R4R4BR5HL7 v2

Validateallow-listed synthetic messageHashpayload SHA-256Replaysame key + same payloadRollbackprovenance retained

Clinical entity creation disabled in the Phase 6 provenance path · Live clinical import disabled in Phase 5 · Phase 7 synthetic transactional apply only

EVIDENCE + CORRECTIONS

Traceable human workflow

Corrections preserve before/after snapshots and reason. Evidence remains tied to the exact surveillance rule-set version.

✓Rule-set version

✓Device timeline

✓Lab / microbiology evidence

✓Exclusions

✓Reviewer decision

↺Correction provenance

BACTIMA BRIDGE

Evidence stays evidence

BACTIMAfinalized.v1ICNORA

Opaque tenant-local subject/specimen/finding tokens only. The event contract cannot directly confirm CAUTI, CLABSI, VAE or SSI.

autoConfirmation false

IMMUTABLE REPORT PROVENANCE

Frozen snapshots

SNAPSHOT SHA-2569c7a…e42b

Generated reports store parameters, frozen result snapshot, generation identity and content hash. Update/delete operations are blocked at the database layer.

PRODUCTION GATES

Fail-closed activation

Real patient dataLOCKEDLive FHIRLOCKEDLive HL7 v2LOCKEDVAE automationValidation evidence ≠ activation

KMS / HSM

References, never keys

MADOMIC stores provider, key reference, version and approval metadata only. Raw cryptographic key material is prohibited from tenant and control databases.

DEV_ENV never production approved

REPORT HARDENING

Secure export objects

JSON/CSV reference exports are tenant-scoped, hashed, non-public and immutable. PDF/XLSX remain blocked until deterministic renderers and approved encrypted production object storage are validated.

Risk-adjusted SIR locked

AUTOMATION BOUNDARY

What MADOMIC may automate

Allowed after validationTenant routingStructural validationRate calculationEvidence aggregationIdempotent message processing

Human authority retainedFinal HAI determinationClinical diagnosisTreatment adviceChanging official criteriaUsing live feeds before approval