Issued2025-07-11

IEEE 3350-2025 – Recommended Practice for Improving Generalizability of Artificial Intelligence for Medical Imaging

Recommended PracticeVoluntary

Summary

Defines an architecture and recommended practices for improving the generalizability of AI models used in medical imaging, addressing how models can perform reliably across datasets, populations, devices, institutions, and deployment settings.

Healthcare Implications

Medical-imaging AI developers and healthcare organizations can use the standard to design and evaluate models for performance beyond the original training environment, identify context-specific failure risks, and strengthen external validation before clinical deployment.

Impact Level

Medium

Keywords

Safety & Risk; Clinical Quality & Efficacy; Equity & Bias

Stakeholders

Providers & Health Systems; Developers & Vendors; Regulators & Government