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Requirement analysis, design, implementation, evaluation, use, and maintenance of semantically interoperable Health Information Systems (HIS) have to be based on eHealth standards. HIS-DF is a comprehensive approach for HIS architectural development based on standard information models and vocabulary. The empirical validity of HIS-DF has not been demonstrated so far. Through an empirical experiment, the paper demonstrates that using HIS-DF and HL7 information models, semantic quality of HIS architecture can be improved, compared to architectures developed using traditional RUP process. Semantic quality of the architecture has been measured in terms of model's completeness and validity metrics. The experimental results demonstrated an increased completeness of 14.38% and an increased validity of 16.63% when using the HIS-DF and HL7 information models in a sample HIS development project. Quality assurance of the system architecture in earlier stages of HIS development presumes an increased quality of final HIS systems, which supposes an indirect impact on patient care.
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