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Production readiness

UnifyEMPI provides an engineering foundation. A successful build or demo does not establish clinical safety, regulatory approval or production fitness.

  1. Clinical safety and governance — define intended use, hazards, safety controls, ownership, escalation and release evidence.
  2. Data protection — complete the applicable DPIA, lawful-basis analysis, retention design, data-sharing agreements and subject-rights process.
  3. Identity and access — connect an approved OIDC issuer, issue tenant/source claims from trusted service identities, enforce least privilege and review access regularly.
  4. Matching assurance — evaluate blocking recall and match precision against governed representative data, approve thresholds and version every profile.
  5. Secure networking — expose FHIR and portal endpoints through approved HTTPS ingress; keep MLLP private and require mutual TLS.
  6. Durability and recovery — verify backups, restore, reconciliation, idempotency, concurrency and disaster-recovery procedures.
  7. Secrets and cryptography — store blocking HMAC keys, OIDC secrets and TLS material in managed secret stores; document rotation and re-index consequences.
  8. Operations — establish monitoring, audit review, incident response, capacity planning, dependency scanning and change control.
  • Every operation has one trusted tenant.
  • Source-system writes have one trusted source identity.
  • Candidate discovery remains bounded; broad searches fail safely.
  • Organisation-owned source records are not edited through the operations portal.
  • Matching-profile changes are deployed consistently to API, portal and MLLP hosts.
  • Logs, traces, metrics and exceptions do not contain patient values.
  • Demos contain synthetic data only.

Treat the following as exit criteria rather than optional polish:

  • matching and blocking acceptance evidence;
  • threat model and penetration-test remediation;
  • clinical-safety case and named safety ownership;
  • approved operational runbooks and on-call routes;
  • tested backup, restore and key-rotation procedures;
  • 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 and the security policy alongside your organisation’s own standards.