Production readiness
UnifyEMPI provides an engineering foundation. A successful build or demo does not establish clinical safety, regulatory approval or production fitness.
Required workstreams
Section titled “Required workstreams”- Clinical safety and governance — define intended use, hazards, safety controls, ownership, escalation and release evidence.
- Data protection — complete the applicable DPIA, lawful-basis analysis, retention design, data-sharing agreements and subject-rights process.
- Identity and access — connect an approved OIDC issuer, issue tenant/source claims from trusted service identities, enforce least privilege and review access regularly.
- Matching assurance — evaluate blocking recall and match precision against governed representative labels; assess subgroups, reviewer agreement and drift; approve thresholds, priors, nickname content and every profile version.
- Secure networking — expose FHIR and portal endpoints through approved HTTPS ingress; keep MLLP private and require mutual TLS.
- Durability and recovery — verify backups, restore, re-index, reconciliation, worker-lease recovery, idempotency, concurrency and disaster-recovery procedures.
- Secrets and cryptography — store blocking HMAC keys, OIDC secrets and TLS material in managed secret stores; document rotation and re-index consequences.
- Operations — establish monitoring, audit review, incident response, capacity planning, dependency scanning and change control.
Deployment invariants
Section titled “Deployment invariants”- Every operation has one trusted tenant.
- Source-system writes have one trusted source identity.
- Candidate discovery remains bounded; broad searches fail safely.
- Population iteration occurs only in durable background maintenance jobs; it never becomes an online matching fallback.
- External FHIR imports are read-only, same-origin paged and snapshot-based; absence is not treated as deletion.
- Organisation-owned source records are not edited through the operations portal.
- Matching-profile changes are deployed consistently to API, portal and MLLP hosts.
- Calibration output is never activated automatically, and assurance labels never cross tenant boundaries.
- Logs, traces, metrics and exceptions do not contain patient values.
- Demos contain synthetic data only.
Before go-live
Section titled “Before go-live”Treat the following as exit criteria rather than optional polish:
- matching and blocking acceptance evidence from a representative dataset, including blocking recall, precision/recall intervals, important subgroup results, an independent calibration holdout and an approved production match prior;
- threat model and penetration-test remediation;
- clinical-safety case and named safety ownership;
- approved operational runbooks and on-call routes;
- tested backup, restore, key-rotation, re-index, cancellation, lease-expiry and reconciliation procedures;
- an approved reconciliation cadence and accountable review-queue owners;
- approved, versioned nickname dictionaries or an explicit decision to keep them disabled;
- load and failure testing at representative scale;
- migration and rollback plans for product-owned identifiers; and
- explicit sign-off from the relevant information-governance, security and clinical authorities.
Use the configuration reference, the normative matching rules, the existing FHIR integration guides, the maintenance runbook, the matching assurance guide, the security architecture and the security policy alongside your organisation’s own standards.