{ "resourceType" : "AuditEvent", "id" : "sc-02-validation-audit-event-ai-execution-001", "meta" : { "profile" : ["http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-machine-execution-audit-event"] }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: AuditEvent sc-02-validation-audit-event-ai-execution-001

Profile: EU AI Execution Audit Event

EU AI Act Log Integrity Signature: No display for Signature (type: Verification Signature (ASTM Signature Type Codes#1.2.840.10065.1.12.1.5); when: 2026-03-01 10:15:04+0000; who: ->Device: extension = ,->DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.; identifier = EU AI Database Identifier:\u00a0EU-AI-000123; status = active; manufacturer = ExampleMed AI GmbH; contact = contact@examplemed.example(Work),dpo@examplemed.example(Work); note = Synthetic maintenance information for PoC purposes.,AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.; sigFormat: text/plain; data: c2hhMjU2LTIzNGY0MmQxMzQyN2YyMzRiOWU3YTg5NTJjMGU1ZjA1MmRkZDNiNTBkMWMxMGZjY2Q0OWNjN2EwMWM5OWQ0NjA=)

code: RESTful Operation

action: Create

occurred: 2026-03-01 10:15:00+0000 --> 2026-03-01 10:15:03+0000

recorded: 2026-03-01 10:15:04+0000

authorization: Document simulated AI execution for PoC traceability.

patient: Anonymous Patient Female, DoB: 1959-04-12

encounter: Encounter: status = completed; class = ambulatory; actualPeriod = 2026-03-01 10:00:00+0000 --> 2026-03-01 10:30:00+0000

Agents

-WhoRequestor
*Device: extension = ,->DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.; identifier = EU AI Database Identifier:\u00a0EU-AI-000123; status = active; manufacturer = ExampleMed AI GmbH; contact = contact@examplemed.example(Work),dpo@examplemed.example(Work); note = Synthetic maintenance information for PoC purposes.,AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.false

Sources

-Observer
*Device: extension = ,->DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.; identifier = EU AI Database Identifier:\u00a0EU-AI-000123; status = active; manufacturer = ExampleMed AI GmbH; contact = contact@examplemed.example(Work),dpo@examplemed.example(Work); note = Synthetic maintenance information for PoC purposes.,AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.

entity

what: Observation

role: Domain Resource

entity

what: Observation Heart rate

role: Domain Resource

entity

what: Observation Respiratory rate

role: Domain Resource

entity

what: Observation

role: Domain Resource

entity

what: Observation Oxygen saturation in Arterial blood

role: Domain Resource

entity

what: Observation

role: Domain Resource

entity

what: Observation

role: Report

" }, "extension" : [{ "url" : "http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity", "valueSignature" : { "type" : [{ "system" : "urn:iso-astm:E1762-95:2013", "code" : "1.2.840.10065.1.12.1.5", "display" : "Verification Signature" }], "when" : "2026-03-01T10:15:04Z", "who" : { "reference" : "Device/device-riskassist-ai" }, "sigFormat" : "text/plain", "data" : "c2hhMjU2LTIzNGY0MmQxMzQyN2YyMzRiOWU3YTg5NTJjMGU1ZjA1MmRkZDNiNTBkMWMxMGZjY2Q0OWNjN2EwMWM5OWQ0NjA=" } }], "code" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/audit-event-type", "code" : "rest", "display" : "RESTful Operation" }], "text" : "RESTful Operation" }, "action" : "C", "occurredPeriod" : { "start" : "2026-03-01T10:15:00Z", "end" : "2026-03-01T10:15:03Z" }, "recorded" : "2026-03-01T10:15:04Z", "authorization" : [{ "text" : "Document simulated AI execution for PoC traceability." }], "patient" : { "reference" : "Patient/patient-001" }, "encounter" : { "reference" : "Encounter/encounter-001" }, "agent" : [{ "who" : { "reference" : "Device/device-riskassist-ai" }, "requestor" : false }], "source" : { "observer" : { "reference" : "Device/device-riskassist-ai" } }, "entity" : [{ "what" : { "reference" : "Observation/sc-02-validation-observation-temperature-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "4", "display" : "Domain Resource" }], "text" : "Domain Resource" } }, { "what" : { "reference" : "Observation/sc-02-validation-observation-heart-rate-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "4", "display" : "Domain Resource" }], "text" : "Domain Resource" } }, { "what" : { "reference" : "Observation/sc-02-validation-observation-respiratory-rate-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "4", "display" : "Domain Resource" }], "text" : "Domain Resource" } }, { "what" : { "reference" : "Observation/sc-02-validation-observation-blood-pressure-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "4", "display" : "Domain Resource" }], "text" : "Domain Resource" } }, { "what" : { "reference" : "Observation/sc-02-validation-observation-oxygen-saturation-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "4", "display" : "Domain Resource" }], "text" : "Domain Resource" } }, { "what" : { "reference" : "Observation/sc-02-validation-observation-consciousness-status-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "4", "display" : "Domain Resource" }], "text" : "Domain Resource" } }, { "what" : { "reference" : "Observation/sc-02-validation-ai-observation-risk-001" }, "role" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/object-role", "code" : "3", "display" : "Report" }], "text" : "Report" } }] }