Gian Iacona

I spent five years building HL7 interfaces to Epic, Athena, Veradigm, and eCW, and now write the performance evaluation plans and pipeline code behind AI/ML 510(k) submissions at Innolitics. On an engagement I write the performance evaluation plan, the algorithm development plans, and the device output inventory that an FDA reviewer will read, then build and test the pipeline code behind them. In 2026 I drafted the performance evaluation plan and centerline development reports for a coronary CT analysis device preparing a 510(k) after its FDA Pre-Sub, and I shipped 14 features (DICOM de-identification, upload telemetry, database backups, offline in-browser de-id) to a research hospital's clinical trial imaging portal, including the verification test record its sponsor's auditor requested. I hold an MS in Computer Science from Georgia Tech, a BS in Aerospace Engineering from UCF, and the InterSystems HL7 Interface Specialist certification, and I presented healthcare interoperability work at HIMSS 2026 and cardiac arrest prediction from EKG data at InterSystems READY 2026. Improving patient health at scale is the mission I signed up for.