@prefix fhir: . @prefix owl: . @prefix rdf: . @prefix rdfs: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:AuditEvent ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "sc-02-validation-audit-event-ai-execution-001"] ; # fhir:meta [ fhir:profile ( [ fhir:v "http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-machine-execution-audit-event"^^xsd:anyURI ; fhir:link ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "

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

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: EU-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: EU-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: EU-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

"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity"^^xsd:anyURI ] ; fhir:value [ a fhir:Signature ; fhir:type ( [ fhir:system [ fhir:v "urn:iso-astm:E1762-95:2013"^^xsd:anyURI ] ; fhir:code [ fhir:v "1.2.840.10065.1.12.1.5" ] ; fhir:display [ fhir:v "Verification Signature" ] ] ) ; fhir:when [ fhir:v "2026-03-01T10:15:04Z"^^xsd:dateTime ] ; fhir:who [ fhir:link ; fhir:reference [ fhir:v "Device/device-riskassist-ai" ] ] ; fhir:sigFormat [ fhir:v "text/plain" ] ; fhir:data [ fhir:v "c2hhMjU2LTIzNGY0MmQxMzQyN2YyMzRiOWU3YTg5NTJjMGU1ZjA1MmRkZDNiNTBkMWMxMGZjY2Q0OWNjN2EwMWM5OWQ0NjA="^^xsd:base64Binary ] ] ] ) ; # fhir:code [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/audit-event-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "rest" ] ; fhir:display [ fhir:v "RESTful Operation" ] ] ) ; fhir:text [ fhir:v "RESTful Operation" ] ] ; # fhir:action [ fhir:v "C"] ; # fhir:occurred [ a fhir:Period ; fhir:start [ fhir:v "2026-03-01T10:15:00Z"^^xsd:dateTime ] ; fhir:end [ fhir:v "2026-03-01T10:15:03Z"^^xsd:dateTime ] ] ; # fhir:recorded [ fhir:v "2026-03-01T10:15:04Z"^^xsd:dateTime] ; # fhir:authorization ( [ fhir:text [ fhir:v "Document simulated AI execution for PoC traceability." ] ] ) ; # fhir:patient [ fhir:link ; fhir:reference [ fhir:v "Patient/patient-001" ] ] ; # fhir:encounter [ fhir:link ; fhir:reference [ fhir:v "Encounter/encounter-001" ] ] ; # fhir:agent ( [ fhir:who [ fhir:link ; fhir:reference [ fhir:v "Device/device-riskassist-ai" ] ] ; fhir:requestor [ fhir:v false ] ] ) ; # fhir:source [ fhir:observer [ fhir:link ; fhir:reference [ fhir:v "Device/device-riskassist-ai" ] ] ] ; # fhir:entity ( [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-observation-temperature-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "4" ] ; fhir:display [ fhir:v "Domain Resource" ] ] ) ; fhir:text [ fhir:v "Domain Resource" ] ] ] [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-observation-heart-rate-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "4" ] ; fhir:display [ fhir:v "Domain Resource" ] ] ) ; fhir:text [ fhir:v "Domain Resource" ] ] ] [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-observation-respiratory-rate-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "4" ] ; fhir:display [ fhir:v "Domain Resource" ] ] ) ; fhir:text [ fhir:v "Domain Resource" ] ] ] [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-observation-blood-pressure-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "4" ] ; fhir:display [ fhir:v "Domain Resource" ] ] ) ; fhir:text [ fhir:v "Domain Resource" ] ] ] [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-observation-oxygen-saturation-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "4" ] ; fhir:display [ fhir:v "Domain Resource" ] ] ) ; fhir:text [ fhir:v "Domain Resource" ] ] ] [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-observation-consciousness-status-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "4" ] ; fhir:display [ fhir:v "Domain Resource" ] ] ) ; fhir:text [ fhir:v "Domain Resource" ] ] ] [ fhir:what [ fhir:link ; fhir:reference [ fhir:v "Observation/sc-02-validation-ai-observation-risk-001" ] ] ; fhir:role [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/object-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "3" ] ; fhir:display [ fhir:v "Report" ] ] ) ; fhir:text [ fhir:v "Report" ] ] ] ) . # # -------------------------------------------------------------------------------------