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Sensible regulation and clinical implementation of clinical decision support software as a medical device
6
Zitationen
7
Autoren
2022
Jahr
Abstract
Recently published research determined that the Epic Systems Corporation Sepsis Model-a widely implemented electronic health record (EHR) based software to identify patients with sepsis-performed poorly at identifying patients at risk for sepsis compared with standard workflows, despite generating added burden for clinicians. 1 While the company had internally validated the model in 2015, limited information was made public about the algorithm's performance because it-like many other clinical decision support tools-did not require clearance from the United States Food and Drug Administration (FDA) before being used in patient care.
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