MammoClean: Toward Reproducible and Bias-Aware AI in Mammography through Dataset Harmonization

Abstract: The development of clinically reliable AI systems for mammography is hindered by profound heterogeneity in data quality, metadata standards, and population distributions across public datasets. This heterogeneity introduces dataset-specific biases that severely compromise the generalizability of the model, a fundamental barrier to clinical deployment. We present MammoClean, a public framework for standardization and bias quantification in mammography datasets. MammoClean standardizes case selection, image processing (including laterality and intensity correction), and unifies metadata into a consistent multi-view structure. We provide a comprehensive review of breast anatomy, imaging characteristics, and public mammography datasets to systematically identify key sources of bias. Applying MammoClean to three heterogeneous datasets (CBIS-DDSM, TOMPEI-CMMD, VinDr-Mammo), we quantify substantial distributional shifts in breast density and abnormality prevalence. Critically, we demonstrate the direct impact of data corruption: AI models trained on corrupted datasets exhibit significant performance degradation compared to their curated counterparts. By using MammoClean to identify and mitigate bias sources, researchers can construct unified multi-dataset training corpora that enable development of robust models with superior cross-domain generalization. MammoClean provides an essential, reproducible pipeline for bias-aware AI development in mammography, facilitating fairer comparisons and advancing the creation of safe, effective systems that perform equitably across diverse patient populations and clinical settings. The open-source code is publicly available from: https://github.com/Minds-R-Lab/MammoClean.