ODM on FHIR: Towards Achieving Semantic Interoperability of Clinical Study Data

Observational clinical studies play a pivotal role in advancing medical knowledge and patient healthcare. However, to lessen the prohibitive costs of conducting these studies and support evidence-based medicine, results emanating from these studies need to be shared and compared with one another. This paper explores how semantic interoperability of clinical data can be achieved by integrating two prominent standards for clinical data: ODM and FHIR. ODM lacks a rich-enough information model to adequately capture the contextual information of clinical study data. This is overcome by using FHIR’s information model to achieve semantic interoperability of clinical data. This work outlines our ongoing effort to integrate the ODM standard to the FHIR standard. In particular, it demonstrates how the hierarchical ODM model lends itself to be mapped to the ubiquitous FHIR resources. We describe the approach and provide insights into the assumptions made to fit the clinical data extracted from the ODM standard into the FHIR resources. Our focus is not only on mapping the data from ODM to the FHIR models but on capturing the contextual information, present in other sources, such as the study protocol, and which should have been made available with the extracted data. Finally, we discuss the exceptions under which the extracted ODM data does not adequately fit the targeted FHIR resources and offer some insight into a suitable solution.