Risks and Risk Mitigation Strategies Related to AI in Medical Imaging : A Qualitative Case Study of Implementing AI in Screening Mammography

Abstract: AI in medical imaging is promising. Breast cancer screening has particularly seen advancements as researchers have demonstrated how commercially available AI algorithms could detect breast cancer at the same level as the best radiologists. The clinical uptake of AI implementations has however been slow and research studies on the real-life effects AI would have when it is implemented in healthcare settings, are lacking. As AI is integrated into the workflows of hospitals, new risks, are likely to be introduced. The breast radiology department at the hospital of Capio S:t Göran is among the first in the world to clinically let AI act as an independent reader, replacing one of the two radiologists reading the mammograms. This study thus aimed to investigate how a hospital like Capio S:t Göran may prepare for the clinical uptake of AI by exploring risks from an enterprise risk management perspective, i.e., looking beyond risks associated with patient safety, and proposing risk mitigation strategies. Data was qualitatively collected through different means. Brainstorming sessions were conducted with personnel at the hospital, either directly or indirectly involved with AI, with the purpose of identifying risks. Two external experts with competencies in cybersecurity, machine learning, and the ethical aspects of AI, were interviewed as a complement. Insights were also gained via observations at the hospital and internal documents/information. The risks identified were analyzed according to an enterprise risk management framework adopted for healthcare, that assumes risks to be emerging from eight different domains. Additionally, appropriate risk mitigation strategies were identified and discussed. The findings from the study demonstrates 23 risks associated with the clinical AI implementation in medical imaging and proposes risk mitigation strategies to each identifiedrisk. Not only does the study indicate the emergence of clinical/patient safety risks, but it also shows that there are operational, strategic, financial, human capital, legal, and technological risks. In addition, the study emphasizes the existence of possible synergies between the risks. The study concludes on the significance for hospitals to view risks holistically and to manage them proactively.