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Scope

This Implementation Guide (IG) provides comprehensive guidance on leveraging the FHIR Provenance resource to ensure the traceability, trustworthiness, and accountability of clinical data within Ontario Health (OH) digital health assets. This IG will enable healthcare organizations, solution vendors, and system integrators in Ontario define the FHIR profiles and business rules for Ontario Health to create and manage standardized audit trails within OH digital health assets. The guidance defines how to record the origin and history of a resource (e.g., who created it, what device it came from, and when it was attested to), which is essential for clinical safety, data quality, and privacy auditing.

Currently this IG is intended for OH internal use only. External organizations and partners can use this IG as a reference for visibility in how Provenance resource is used in OH’s digital health assets however they are not required to implement this IG.

In Scope

This IG is focused on the use cases, system interactions, and FHIR profiles for creating, reading, and searching Provenance resources alongside clinical data to Ontario Health digital health assets. It covers the creation of provenance for key data lifecycle events.

Out of Scope

The following items are excluded from the scope of this IG and shall not be a concern for system integrators will be documented separately such as in architecture design documents:

  • The internal processing, validation, or auditing of Provenance records within Ontario Health's back-end systems.
  • The specific business rules or policies dictating which clinical events require an audit; this guide only specifies how to record the provenance once an event is determined to be in scope.
  • Provenance for data that does not originate from a Health Information Custodian (HIC), such as unverified patient-reported outcomes (TBC).

This guide covers:

  • Provenance Resource Profile: Core requirements and constraints for the Provenance resource in Ontario.

  • Interactions: Guidance for Create Provenance, Read Provenance, and Search Provenance operations.

  • Use cases: Examples for key scenarios, including HALO/SoFA, HL7 v2 Data Submission, FHIR Data Submission, and FHIR Data Migration.

This guide will empower you to:

  • Ensure the traceability and trustworthiness of the clinical data you exchange.

  • Create a standardized and interoperable audit trail for health information.