A Responsible Framework for Applying Artificial Intelligence on Medical Images and Signals at the Point of Care: The...

The potential of artificial intelligence (AI) in medicine lies in its ability to enhance clinicians' capacity to analyse medical images, thereby improving diagnostic precision and accuracy and thus enhancing current tests. However, the integration of AI within health care is fraught with difficulties. Heterogeneity among health care system applications, reliance on proprietary closed-source software, and rising cybersecurity threats pose significant challenges. Moreover, before their deployment in clinical settings, AI models must demonstrate their effectiveness across a wide range of scenarios and must be validated by prospective studies, but doing so requires testing in an environment mirroring the clinical workflow, which is difficult to achieve without dedicated software. Finally, the use of AI techniques in health care raises significant legal and ethical issues, such as the protection of patient privacy, the prevention of bias, and the monitoring of the device's safety and effectiveness for regulatory compliance. This review describes challenges to AI integration in health care and provides guidelines on how to move forward. We describe an open-source solution that we developed that integrates AI models into the Picture Archives Communication System (PACS), called PACS-AI. This approach aims to increase the evaluation of AI models by facilitating their integration and validation with existing medical imaging databases. PACS-AI may overcome many current barriers to AI deployment and offer a pathway toward responsible, fair, and effective deployment of AI models in health care. In addition, we propose a list of criteria and guidelines that AI researchers should adopt when publishing a medical AI model to enhance standardisation and reproducibility.