A Semantic interoperability framework for reinforcing post market safety studies

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2013
Yüksel, Mustafa
Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Enabling safety analysts to seamlessly access a wide range of Electronic Health Record (EHR) sources for collecting de-identified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs can provide major improvements for such post market safety studies. The adoption of EHR systems and data exchange among these systems are rapidly increasing due to a number of national and cross-border initiatives. Although the main priority of these systems is improving clinical care, we demonstrate that the same systems and interfaces can be exploited for post market safety studies as well. We have developed an ontological framework where EHR sources and target clinical research systems can continue to use their own local data models, interfaces and terminology systems; while both structural and semantic interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in our Semantic Resource Set. The Common Information Model at the core of this set acts as the common mediator. Our semantic interoperability framework for post market safety studies is scalable. The quantity and quality of the information provided through our framework to the safety analysts is a significant improvement compared to traditional methods. Semantically mediating all the patient data and terminology systems in formalized representations allows us to extend the capabilities of our tools easily.

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Citation Formats
M. Yüksel, “A Semantic interoperability framework for reinforcing post market safety studies,” Ph.D. - Doctoral Program, Middle East Technical University, 2013.