Challenges in Implementing Artificial Intelligence in Breast Cancer Screening Programs: Systematic Review and Framework for Safe Adoption

Abstract

BACKGROUND: Artificial intelligence (AI) studies show promise in enhancing accuracy and efficiency in mammographic screening programs worldwide. However, its integration into clinical workflows faces several challenges, including unintended errors, the need for professional training, and ethical concerns. Notably, specific frameworks for AI imaging in breast cancer screening are still lacking. OBJECTIVE: This study aims to identify the challenges associated with implementing AI in breast screening programs and to apply the Consolidated Framework for Implementation Research (CFIR) to discuss a practical governance framework for AI in this context. METHODS: Three electronic databases (PubMed, Embase, and MEDLINE) were searched using combinations of the keywords "artificial intelligence," "regulation," "governance," "breast cancer," and "screening." Original studies evaluating AI in breast cancer detection or discussing challenges related to AI implementation in this setting were eligible for review. Findings were narratively synthesized and subsequently mapped directly onto the constructs within the CFIR. RESULTS: A total of 1240 results were retrieved, with 20 original studies ultimately included in this systematic review. The majority (n=19) focused on AI-enhanced mammography, while 1 addressed AI-enhanced ultrasound for women with dense breasts. Most studies originated from the United States (n=5) and the United Kingdom (n=4), with publication years ranging from 2019 to 2023. The quality of papers was rated as moderate to high. The key challenges identified were reproducibility, evidentiary standards, technological concerns, trust issues, as well as ethical, legal, societal concerns, and postadoption uncertainty. By aligning these findings with the CFIR constructs, action plans targeting the main challenges were incorporated into the framework, facilitating a structured approach to addressing these issues. CONCLUSIONS: This systematic review identifies key challenges in implementing AI in breast cancer screening, emphasizing the need for consistency, robust evidentiary standards, technological advancements, user trust, ethical frameworks, legal safeguards, and societal benefits. These findings can serve as a blueprint for policy makers, clinicians, and AI developers to collaboratively advance AI adoption in breast cancer screening. TRIAL REGISTRATION: PROSPERO CRD42024553889; https://tinyurl.com/mu4nwcxt.

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