title: Standard-based EHR-enabled applications for clinical research and patient safety: CDISC - IHE QRPH - EHR4CR & SALUS collaboration.
abstract: 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.
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France ; CCS SI Patient, AP-HP, Paris, France.
authors.forename: Christel
authors.initials: C
authors.lastname: Daniel
authors.affiliation: Software Research, Development and Consultancy, Ankara, Turkey.
authors.forename: Anil
authors.initials: A
authors.lastname: Sinaci
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Ouagne
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Sadou
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Declerck
authors.affiliation: University College London, UK.
authors.forename: Dipak
authors.initials: D
authors.lastname: Kalra
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Charlet
authors.affiliation: AstraZeneca, Sweden.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Forsberg
authors.affiliation: CDISC.
authors.forename: Landen
authors.initials: L
authors.lastname: Bain
authors.affiliation: W3C.
authors.forename: Charlie
authors.initials: C
authors.lastname: Mead
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France.
authors.forename: Sajjad
authors.initials: S
authors.lastname: Hussain
authors.affiliation: CCS SI Patient, AP-HP, Paris, France.
authors.forename: Gokce B
authors.initials: GB
authors.lastname: Laleci Erturkmen
keywords: Adverse Drug Reaction Reporting Systems; Biomedical Research; Electronic Health Records; Pharmacovigilance; Terminology as Topic