Framework for Clinical Validation of an AI-Assisted Portable Breast Cancer Screening System

Breast cancer remains a major global health challenge, and early detection substantially improves survival outcomes. This work presents a framework for the clinical validation of an AI-assisted portable breast cancer screening system designed to support future clinician-supervised deployment in diverse healthcare settings.

Using standardized diagnostic features and supervised machine learning classification, initial validation demonstrated strong classification performance (98.25% accuracy). The proposed framework integrates methodological reproducibility, ethical oversight, clinician supervision, and translational healthcare considerations to support responsible AI-assisted screening applications.

Keywords: Breast cancer screening; clinical validation; translational healthcare; clinical decision support; equitable access.