Compliance

Capabilities

Implemented

  1. FHIR implementation guides containing profiles shall be loadable for validation purposes Implemented Functional
  2. Clinical data shall be validated prior to submission Implemented Functional
  3. Clinical data shall meet USCore standard compliance requirements Implemented Non-Functional
  4. Open source validation technologies shall be used for FHIR standard compliance validation Implemented Non-Functional
  5. The system shall support importing FHIR implementation guides containing validation profiles Implemented Functional
  6. The system shall validate all clinical data against USCore profiles Implemented Operational
  7. The system shall use the HAPI FHIR validator for FHIR standard compliance validation Implemented Functional
    Definition

    https://hapifhir.io/hapi-fhir/docs/validation/instance_validator.html

  8. The system shall persist validation results in a queryable database Implemented Functional
  9. The system shall support creation and management of validation result categories Implemented Functional
  10. The system shall provide visualization of validation results with category-to-detail navigation Implemented Functional
  11. The system shall maintain an "uncategorized" category for validation results without defined categories Implemented Functional

Pending

  1. The system shall execute validation checks on clinical data before allowing submission Pending Functional

Compliance Domain

Responsible for ensuring that Link operates within defined policies. This includes both operational compliance (e.g., security controls auditing) and data compliance (e.g., validating data syntax and semantics against prescribed profiles and standards).

Key Concepts

  • Data Governance: Setting policy and assuring compliance

Relationships

flowchart LR
subgraph nCompliance_DBAE25D_domain["Domain: Compliance"]
    nAccountService_9DE0178["Service: Account Service"]
    nAuditService_3DEF243A["Service: Audit Service"]
    nValidationService_20F4F748["Service: Validation Service"]
    nAuditableEventOccurred_2E7ED8D7["Event: Auditable Event Occurred"]
    nValidationComplete_7F3C0D47["Event: Validation Complete"]
    nReadyForValidation_293CC34C["Event: Ready for Validation"]
    nMeasureReportGenerated_38AFFB54["Event: Measure Report Generated"]
    nresources_normalized_28215193["Event: Resources Normalized"]
    nValidateValueSetCode_2E2BA8B0["Command: Validate ValueSet Code"]
    nValidateCodeSystemCode_15D077E8["Command: Validate CodeSystem Code"]
    nEvaluationRequested_7F27B0ED["Command: Evaluation Requested"]
  end