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. 2025 Apr 23;27:e69813. doi: 10.2196/69813

Table 2.

Summary of mapping the interoperability standards to the European Health Data Space for the secondary use of data template based on the European Interoperability Framework using the Towards the European Health Data Space and Improving Cancer Diagnosis and Prediction with AI [artificial intelligence] and Big Data Results.

EIFa TEHDASb [6] Governance model of the EHDS2c of the data life-cycle INCISIVEd [19] Recommendations of interoperability standards (managing clinical data and medical images) HSbooster.eu synergy projects [31,32] (the main health and IoMTe standardsf)
Legal The EHDSg will build on the legal frameworks laid out by the EUh regulations (Figure 1)

  • Legal and security standards and FAIRi principles. The detailed explanation is provided in INCISIVE’s Deliverable 7.3 Data donation legal framework

  • ISOj 14971 Medical Devices Risk Management Assessment

  • IECk 62304 Medical device software - Software life cycle processes

  • ISO/IEC 27001:2022-

  • Information security, cybersecurity, and privacy protection

  • IEEEl 7000 Series- AI ethical considerations

  • ISO/IEC 42001_2023 – AI – Management system and requirements
Organizational

  • Adapting the national policies in compliance with the EHDS regulations

  • Harmonizing the EU member states health policies and the delivery of health services and medical care

 The IHEm integration profiles identified the care process, actors, transactions, and events

  • IHE integration profiles

  • ISO/IEC 5259-1:2024

  • Artificial intelligence — Data quality for analytics and machine learning

  • ISO 9000: Data Quality Management Systems standards

  • Data quality frameworks

  • Data FAIRification framework
Semantic

  • Standards on data discoverability: (DCAT-APn)

  • Standards that allow semantic interoperability: (OMOP-CDMo)

  • SNOMED CTp (Clinical data) LOINCq (Lab data)

  • OHDSIr vocabularies

  • SNOMED, LOINC, ICDs, RxNorm, etc

  • ISO 13606-Health Informatics- Electronic Health Record —Parts 1,2,4 (Reference model/ Archetype interchange specification / Security)

  • ISO 11073-10101 and ISO 11073-10201- Health informatics — Device Interoperability (Point-of-care medical device communication — Domain information model/Nomenclature)

  • ISO 23903:2021

  • Health informatics — Interoperability and integration reference architecture — Model and framework

  • Standards on data discoverability: HealthDCAT-AP

  • OMOPt for enabling data analysis

  • ISO/IEC 22989: AI concept and terminology
Syntactic

  • Standards that facilitate communication: FHIRu (Clinical data)

  • DICOMv (Imaging data)

  • FHIR (All data)

  • DICOM (Imaging data)

  • HL7, FHIR (Clinical data)

  • DICOM (Imaging data)

  • ISO/IEEE 11073-20601 and ISO/IEEE 11073-20701 (PGHD- Device Interoperability and optimized exchange protocol)

  • EN/ISO 13606: Health Informatics- Electronic Health Record —Parts 3,5(Reference archetypes and term lists/Interface specification)
Technical

  • Federated peer-to-peer (P2P) network

  • Secure processing environment

 JSON or XML

  • Semantic web languages such as W3Cw RDFx, RDFSy, OWLz, SPARQLaa, JSON-LDab, etc

  • JSON or XML (medical data)

  • ISO accreditation for the EHDS2 secure processing environment, for example, ISO/IEC 27001

  • IEEE 3652.1, Guide for Architectural Framework and Application of Federated Machine Learning

aEIF: European Interoperability Framework.

bTEHDAS JA: Towards the European Health Data Space Joint Action.

cEHDS2: European Health Data Space for the secondary use of data.

dINCISIVE: improving cancer diagnosis and prediction with AI and big data.

eIoMT: Internet of Medical Things.

fThe complete list of standards is available in the toolkit. The table highlights the main standards used in health and IoMT

gEHDS: European Health Data Space.

hEU: European Union.

iFAIR: Findability, Accessibility, Interoperability, and Reusability.

jISO: International Standards Organization.

kIEC: Internation Electrochemical Commission.

lIEEE: Institute of Electrical and Electronics Engineers.

mIHE: Integrating the Healthcare Enterprise.

nDCAT-AP: Data Catalogue vocabulary Application Profile for data portals.

oOMOP-CDM: Observational Medical Outcomes Partnership Common Data Model.

pSNOMED CT: Systematized Nomenclature of Medicine – Clinical Terms.

qLOINC: Logical Observation Identifiers Names and Codes.

rOHDSI: Observational Health Data Sciences and Informatics.

sICD: International Classification of Diseases.

tOMOP mapping (linking the semantic layer with the syntactic layer)

uFHIR mapping (linking the semantic layer with the syntactic layer).

vDICOM: Digital Imaging and Communications in Medicine.

wW3C: World Wide Web Consortium.

xRDF: Resource Description Framework.

yRDFS: Resource Description Framework Schema.

zOWL: Web Ontology Language.

aaSPARQL: SPARQL Protocol and RDF Query Language.

abJSON-LD: JSON for Linked Data.