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A hospital quality assurance program (H-QAP) assures compliance in the real-world clinical environment via evidence-based best practices in patient and software systems management. Software Systems Embedded within hardware devices are increasingly prevalent in healthcare settings. They typically integrate information from devices and applications that collect, store, manipulate, and report clinical data. Authorities such as the US Food and Drug Administration (FDA) regulate software within hardware devices and the EU has recently deemed stand alone software to be medical device.
Date of Publication: May-June 2012