Issued2026-03-01

Post-deployment Monitoring and Safety Reporting of AI Medical Imaging Devices in Clinical Practice

Professional GuidanceVoluntary

Summary

Recommends a structured approach to monitoring deployed imaging AI in radiology and oncology: assign responsibility, inventory devices, monitor people, processes and performance, collect audit data, investigate problems, and train staff. Includes supplier questions and operational case studies.

Healthcare Implications

Clinical providers can embed AI monitoring within local governance, track errors and drift, and escalate safety concerns. This professional guidance complements manufacturer surveillance and existing legal reporting duties; it excludes non-imaging productivity tools and does not itself impose new legal obligations.

Impact Level

Medium

Keywords

Safety & Risk; Clinical Quality & Efficacy; Transparency & Governance

Stakeholders

Providers & Health Systems; Developers & Vendors