Self-testing data clinician presentation application software IVD
Definition
An application software program designed as an Internet-based information system intended to be used by a healthcare professional to view the results of a self-test [e.g., immunochromatographic test (ICT)] performed by a patient. The software receives data from the patient’s mobile device (e.g., smartphone) application software, through a web portal, and presents the results to the healthcare professional for review and assessment.