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1.3. 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. 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 regulatory audit support.

This IG is intended for OH internal use only.

1.3.1. 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.

1.3.2. Out of Scope

The following items are excluded from the scope of this IG:

• The internal processing, validation, or auditing of Provenance records within Ontario Health's back-end systems.
• The specific business rules or policies dictating how to process or use Provenance; 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).

1.3.3. This guide covers:

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

• Interactions: Guidance for Search Provenance interaction.

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

1.3.4. This guide will empower you to:

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

• Create a standardized and interoperable way to capture the origin, history, and lifecycle of data (or an asset) — essentially where it came from, how it changed, and who touched health information.