Table 1.

Assessment of health data standards by category for the secondary use of health data in the IDERHA^a project. For each of the data categories identified in this study, the table lists the candidate standards evaluated and their scores across 5 criteria each rated high, medium, low, or partial.

Data category and standard		Adoption and popularity	Interoperability	OMOPb-CDMc compatibility	EHDSd alignment	Tooling and support	IDERHA role
Observational and clinical data
	OMOP-CDM v5.4	High	High	Primary	High	High	Primary
	HL7e FHIRf	High	High	Partial	High	High	Complementary
	CDISCg SDTMh	High	Medium	Partial	Partial	High	Complementary
	CDISC ADaMi	High	Medium	Partial	Partial	High	Complementary
Terminologies and vocabularies
	OMOP standardized vocabularies	High	High	Primary	High	High	Primary
	SNOMED CTj	High	High	Primary	High	High	Complementary
	LOINCk	High	High	Primary	High	High	Complementary
	RxNorm/ATCl/ICD-10m/CPT-4n/HCPCSo	High	High	Primary	High	High	Complementary
Metadata
	DCAT-APp	Medium	High	Not applicable	High	Medium	Primary
	HealthDCAT-AP	Low	High	Complementary	High	Low	Primary
	Gaia-X Self-Description	Medium	High	Not applicable	High	Medium	Complementary
	CDISC Define-XML	High	Medium	Partial	Partial	High	Complementary
Imaging
	DICOMq	High	High	Extension	High	High	Primary
	OMOP-CDM Imaging extension	Low	Medium	Extension	Partial	Low	Extension
	NIfTIr	Medium	Medium	Partial	Partial	Medium	Complementary
	Genomic CDM (OHDSIs Oncology WG)	Low	Medium	Extension	Partial	Low	Extension
Molecular biology and genetics
	GA4GHt	High	High	Complementary	Partial	High	Complementary
	CDISC SDTM	High	Medium	Partial	Partial	High	Complementary
Security and privacy
	GA4GH Passport	Medium	High	Not applicable	Partial	Medium	Primary
	GA4GH AAIu	Medium	High	Not applicable	Partial	Medium	Primary
	ISO/IECv 27001:2022	High	Medium	Not applicable	High	Medium	Complementary
	eIDASw	High	High	Not applicable	High	Medium	Primary
AI model representation
	ONNXx	High	High	Not applicable	Partial	High	Primary
	MEDSy	Low	Medium	Partial	Partial	Low	Complementary
	ISO/IEC 42001:2023	Medium	Not applicable	Not applicable	Partial	Low	Complementary
	ISO/WDz 24051-2	Low	Low	Not applicable	Partial	Low	Complementary
	ISO/IEC 22989	Medium	Not applicable	Not applicable	Partial	Low	Complementary
Environmental data
	OHDSI GISaa Extension	Low	Medium	Extension	Partial	Low	Extension
	INSPIREab + ISO 19115-1/ISO 19119/ISO 19136	High	Medium	Complementary	High	Medium	Complementary
Socioeconomic data
	HL7 FHIR Gravity	Medium	Medium	Partial	Partial	Medium	Complementary
	ESeC	Medium	Low	Partial	Partial	Low	Complementary
PREMsac/PROMSad
	PROae FHIR IGaf	Medium	High	Partial	Partial	Medium	Primary
	ISO/IEEEag 11073-10201:2020	Medium	Medium	Partial	Partial	Low	Complementary

^aIDERHA: Integration of Heterogeneous Data and Evidence Towards Regulatory and Health Technology Assessment Acceptance.

^bOMOP: Observational Medical Outcomes Partnership.

^cCDM: Common Data Model.

^dEHDS: European Health Data Space.

^eHL7: Health Level Seven.

^fFHIR: Fast Healthcare Interoperability Resources.

^gCDISC: Clinical Data Interchange Standards Consortium.

^hSDTM: Study Data Tabulation Model.

ⁱADaM: Analysis Data Model.

^jSNOMED CT: Systematized Nomenclature of Medicine-Clinical Terms.

^kLOINC: Logical Observation Identifiers Names and Codes.

^lATC: Anatomical Therapeutic Chemical.

^mICD-10: International Classification of Diseases.

ⁿCPT-4: Current Procedural Terminology, 4th edition.

^oHCPCS: Healthcare Common Procedure Coding System.

^pDCAT-AP: Data Catalog Vocabulary Application Profile for European Data Portals.

^qDICOM: Digital Imaging and Communications in Medicine.

^rNIfTI: Neuroimaging Informatics Technology Initiative.

^sOHDSI: Observational Health Data Sciences and Informatics.

^tGA4GH: Global Alliance for Genomics and Health.

^uAAI: Authentication and Authorization Infrastructure.

^vIEC: International Electrotechnical Commission.

^weIDAS: electronic Identification, Authentication, and Trust Services.

^xONNX: Open Neural Network Exchange.

^yMEDS: Medical Event Data Standard.

^zISO/WD: ISO/Working Draft.

^aaGIS: Geographic Information System.

^abINSPIRE: Infrastructure for Spatial Information in the European Community.

^acPREM: patient-reported experience measure.

^adPROM: patient-reported outcome measure.

^aePRO: patient reported outcome.

^afIG: implementation guide.

^agIEEE: Institute of Electrical and Electronics Engineers.