Bridging Gaps in Standards for the Secondary Use of Health Data: Exploratory Standard, Tool Assessment, and...

Standards for the secondary use of health data remain 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 health care, leaving gaps in their applicability for research, regulatory and decision-making. This research is part of the Integration of Heterogeneous Data and Evidence Towards Regulatory and Health Technology Assessment Acceptance (IDERHA) project, which creates a federated processing environment for secondary health care use cases.

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 adherence to findable, accessible, interoperable, and reusable (FAIR) principles and interoperability.

In this exploratory assessment and feasibility study, we performed a consensus-based evaluation of health data standards and harmonization tools across major health-data categories. State-of-the-art standards from different standard-producing organizations were evaluated based on community adoption, technical suitability, and alignment with European Health Data Space requirements. Data-harmonization tools were tested in a pilot experiment using synthetic Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM)-based data to assess the quality and feasibility of applying harmonization workflows within IDERHA. We also assessed the inherent adherence to FAIR principles of the OMOP-CDM, identifying its strengths in semantic interoperability and data reuse. Finally, we addressed the datasets handling challenges (metadata discoverability, global identifiers, access control, and licensing), which are not inherently solvable by bare data description standards, through complementary mechanisms implemented in IDERHA.

We recommend a set of standards to support the secondary use of heterogeneous health data across clinical, imaging, genomic, socioeconomic, environmental, and patient-reported outcome measure (PROM)/patient-reported experience measure (PREM) domains. This standards collection, centered on OMOP-CDM and complemented by established extensions, was paired with selected harmonization and quality-assessment tools. Feasibility testing on synthetic OMOP data confirmed the suitability of the tools for evaluating data quality, mapping accuracy, and extract, transform, and load. A lung-cancer use case demonstrated how diverse datasets can be harmonized and prepared for federated analysis. A FAIR-dataset maturity evaluation showed that integrating OMOP data into the IDERHA environment substantially improved adherence to FAIR principles-particularly in metadata completeness, interoperability, and hosting capabilities-supporting enhanced discoverability, accessibility, and reuse of standardized health data.

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