JMIR Publications

ABSTRACT

Background:

Standards for the secondary use of health data are still under development and do not comprehensively address specific categories of health data. Existing health data and interoperability standards are primarily designed for the primary use of healthcare, leaving gaps in their applicability for research, regulatory and decision-making. This research is part of the IDERHA project, which creates a federated processing environment for secondary healthcare use cases aligned with EHDS regulations.

Objective:

This study aims to recommend a set of standards and tools to support harmonization objectives in the secondary use of health data. The proposed standards establish a shared representation model for data providers and stakeholders, improving data FAIRness and interoperability.

Methods:

A comprehensive review and selection of standards and harmonization tools were performed across major health-data categories. Standards from OHDSI/OMOP, HL7 FHIR, DICOM, DCAT-AP/HealthDCAT-AP, GA4GH, INSPIRE, CDISC, and others were evaluated based on community adoption, technical suitability, and alignment with EHDS requirements. Data-harmonization tools were tested in a pilot experiment using synthetic OMOP-CDM based data to assess readiness, quality, and feasibility of applying harmonization workflows within IDERHA. We also assessed the inherent FAIRness of OMOP CDM, identifying its strengths in semantic interoperability and data reuse, while addressing limitations related to metadata discoverability, global identifiers, access control, and licensing through complementary mechanisms implemented in IDERHA.

Results:

In this research, we recommend a set of standards to support the secondary use of heterogeneous health data across clinical, imaging, genomic, socioeconomic, environmental, and PROM/PREM domains. This standards collection, centered on OMOP CDM and complemented by established domain-specific specifications, was paired with selected harmonization and quality-assessment tools from the OHDSI and EHDEN ecosystems. Feasibility testing on synthetic OMOP data confirmed the suitability of tools for evaluating data quality, mapping accuracy, and ETL. A lung-cancer use case demonstrated how diverse datasets can be harmonized and prepared for federated analysis. FAIR-DSM evaluation showed that integrating OMOP data into the IDERHA environment substantially improved FAIRness—particularly in metadata completeness, interoperability, and hosting capabilities—supporting enhanced discoverability, accessibility, and reuse of standardized health data.

Conclusions:

By strengthening adherence to FAIR principles, this research facilitates the broader integration of standardized health data for regulatory processes and health technology assessment (HTA) applications. The proposed set of standards and tools provides a comprehensive overview of existing approaches, while offering solutions that can be applied to other scenarios involving the secondary use of health data.