​Responsible Use of AI in breast cancer screening

Challenges

AI has the potential to transform healthcare by addressing challenges such as increased demand for care and a shortage of staff. In breast cancer screening, studies show that AI can save time, consequently improving access to qualified personnel and enhancing diagnostic quality.

Despite the rapid development of AI, its implementation in healthcare remains limited. Interpretation of legal frameworks, a lack of coordinated initiatives, and insufficient guidance from national agencies are some of the barriers to implementation. 

Other challenges include the validation of AI models, ensuring adequate competence, and access to data. Since conditions and resources vary among regions, there's a risk that AI implementation could lead to increased healthcare inequalities rather than leveling disparities. 

This highlights the need for national guidance and clinical practice guidelines to ensure the responsible use of AI, as well as quality and access to equitable care within screening programs.

Project purpose

This project is a preliminary study that will map out challenges, needs, and potential solutions. The focus will be on regulations, ethics, responsibility, patient safety, and cost-effectiveness. The goal is to develop a prototype for a knowledge support system that facilitates the responsible use of AI in breast cancer screening. The work will be carried out in close collaboration with relevant stakeholders and other initiatives.

Expected outcomes

• Increased understanding of regulations: The project will enhance understanding of how relevant legal frameworks impact the use of AI in breast cancer screening.
• Prototype for AI use support: The project will deliver a prototype for supporting regions in addressing challenges that arise from the use of AI in breast cancer screening, with potential for application in other screening programs.
• Prototype for medical device regulations support: A prototype for supporting the regulatory framework for medical devices related to AI technology in breast cancer screening, with a special focus on the National Board of Health and Welfare's regulations concerning medical devices and other relevant legal provisions.

Long-term results: Despite its focus on AI in breast cancer screening, this preliminary study is also expected to provide increased knowledge on how the National Board of Health and Welfare can meet healthcare providers' needs regarding innovation and AI use in general. It will also enhance the National Board of Health and Welfare's capacity to develop guidelines and indicators related to new technologies and the authority's mandate.

The results will be disseminated through the networks of the National Board of Health and Welfare and AI Sweden and shared with relevant authorities and healthcare stakeholders.

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