Xt-EHR T7.2 Sub-team for Imaging Reports Model Xt-EHR T7.2

Project References

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Project References and Traceability

🎯 Original Project Request

Analyze the Xt-EHR Imaging Report information model to identify which data elements are actually used in real-world imaging reports versus those that could be considered 'beyond basic' by comparing with real-world imaging reports from the PARROT dataset.

📚 Data Source References

🏛️ Xt-EHR Project

Resource Link Description
Official Site xt-ehr.eu Xt-EHR Joint Action homepage
Model History Version History EHDS Logical Information Models releases
Current Version v0.2.1 (Oct 10, 2025) First preview version analyzed
GitHub Repository Xt-EHR/xt-ehr-common Source code and model definitions
Issues Tracker GitHub Issues Active model development discussions

🔍 Specific Model References

Model Component Source File Analysis Focus
Imaging Report imagingReport.fsh Complete report structure and elements
Imaging Study imagingStudy.fsh DICOM metadata and study organization

📊 PARROT Project

Resource Link Description
Dataset Repository PARROT v1.0 Multi-language radiology reports
Dataset Characteristics 2,738 reports 14 languages, 21 countries, 10 modalities
Research Purpose Real-world evidence Clinical usage pattern analysis

🔗 Model Traceability Matrix

Element Classification Mapping

Our Classification Xt-EHR Model Path Real-World Evidence Implementation Priority
BASIC (11 elements) header.subject, body.examinationReport.* 90%+ clinical coverage High - Core functionality
INTERMEDIATE (6 elements) body.recommendation.*, body.comparisonStudy.* 25-75% usage, high value Medium - Enhanced workflows
BEYOND BASIC (31+ elements) header.authorship.*, header.documentMetadata.* <25% usage, admin focus Low - Specialized needs

Direct Model References

Header Elements (Administrative)

// Source: EHDSImagingReport.header
* header.authorship 1..* Base "Report authoring details"
  * author[x] ^short = "Author by whom the document was authored"
  * datetime 1..1 dateTime "Date and time of last modification"

Body Elements (Clinical Content)

// Source: EHDSImagingReport.body.examinationReport
* examinationReport 1..1 Base "Examination report content"
  * modality 1..* CodeableConcept "Imaging modality used"
  * bodyPart 0..* EHDSBodyStructure "Body parts investigated"
  * conclusion 1..1 Base "Clinical conclusion and impression"

📈 Analysis Process Validation

Methodology Verification

  1. Model Extraction: Direct parsing of FSH files from official repository
  2. Version Control: Specific to v0.2.1 release (October 10, 2025)
  3. Real-World Evidence: Quantitative analysis of PARROT dataset
  4. Cross-Validation: Mapping between model elements and usage patterns

Quality Assurance

🎯 Implementation Guidance

Phase 1: Basic Profile

Target: 11 Core Elements - Focus on essential clinical content - 90%+ real-world value coverage - Low implementation complexity

Phase 2: Enhanced Profile

Target: 6 Intermediate Elements - Workflow enhancement features - Use case driven implementation - Medium complexity integration

Phase 3: Comprehensive Profile

Target: 31+ Beyond Basic Elements - Administrative and technical completeness - Specialized institutional requirements - High complexity implementation

🇪🇺 EU AI Act Compliance References

AI Regulatory Framework

Resource Link Purpose
EU AI Act (Full Text) Regulation (EU) 2024/1689 Primary legislation
EU AI Act Overview European Commission AI Hub Policy guidance and implementation
European Approach to AI Excellence and Trust Framework Strategic EU AI approach
Irish Implementation Enterprise Ireland AI Act National guidance and timeline
AI Act Service Desk Single Information Platform Interactive compliance tools

AI Analysis Attribution

Model Used: Claude Sonnet 4.5 (Anthropic)
Classification: General-Purpose AI (GPAI) Model under EU AI Act Article 3(44) and (51)
Transparency Compliance: Article 52 - AI-generated content disclosure
Project Compliance Document: EU-AI-ACT-COMPLIANCE.md

Healthcare and EHDS Context

Resource Link Purpose
European Health Data Space EHDS Regulation Healthcare data framework
GDPR Regulation (EU) 2016/679 Data protection compliance

📋 Document Cross-References

Document Purpose Key References
README.md Project overview with EU AI Act compliance Original prompt, methodology, AI attribution
EU AI Act Compliance Regulatory compliance statement Risk classification, transparency, GPAI obligations
Executive Summary Key findings with AI attribution Results, recommendations, compliance disclosure
Process Flow Detailed methodology Visual process diagram, validation steps
Element Analysis Complete element inventory Direct model references, usage patterns
PARROT Analysis Dataset analysis with AI attribution Real-world evidence, statistical analysis
Beyond Basic Classification Specialized elements analysis Low-usage elements, admin focus
PARROT Analysis Real-world usage evidence Quantitative statistics, coverage analysis
Executive Summary Key findings and recommendations Evidence-based guidance, implementation strategy

🔄 Continuous Updates

This analysis maintains synchronization with: - Xt-EHR Model Evolution: Monitor repository for updates - PARROT Dataset Releases: Track new versions for expanded analysis - Implementation Feedback: Real-world deployment insights for classification refinement


This document ensures complete traceability between our analysis, source data models, and real-world evidence for evidence-based Xt-EHR implementation guidance.

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