Standard-based EHR-enabled applications for clinical research and patient safety: CDISC – IHE QRPH – EHR4CR & SALUS collaboration

Integration profiles collaboratively developed by CDISC and IHE for integrating data from Electronic Health Records (EHRs) with clinical research and pharmacovigilance are limited to resolving lexical/syntactic data integration issues and do not address semantic barriers. This paper describes the collaboration between two European projects - EHR4CR and SALUS - in implementing ISO/IEC 11179-based metadata registries (MDRs) and semantically integrated cross-platform data access. A common "semantic MDR" provides a framework for bidirectional/cross-MDR mapping and federated queries are enabled using the newly-defined IHE Data Exchange (DEX) profile. In the pilot implementation, mappings for 178 EHR4CR and 199 SALUS metadata elements were persisted in the semantic MDR. The DEX profile was then used to access semantically equivalent data elements in SALUS or EHR4CR participating EHR systems. ISO/IEC 11179-based MDRs and DEX integration profile address the goal of developing pan-EU computable semantic integration of data from clinical care, clinical research, and patient safety platforms.