Transitioning from post-incident retrospective reviews to automated prospective regulatory filing dramatically reduces compliance penalties and saves patient lives. This paper details the software architecture required to extract, normalize, and file MedWatch 3500A reports automatically.
By querying hospital FHIR servers for device anomaly resources paired with vital sign drops, the ingestion pipeline constructs a complete temporal picture of device failure without human transcription delay.
The normalized dataset is transformed into an HL7 Individual Case Safety Report (ICSR) XML document, validating every schema restriction prior to triggering the AS2 transmission.