À¯È¿¼º°á°ú(Recomendation)
As AI-SaMDs for CR begin to be applied in clinical practice, there is a growing concern regarding the legal liability for any patient harm related to the utilization of AI-SaMDs. It is difficult to present an evidence-based opinion regarding liability, as AI-SaMD itself or its clinical introduction remains in its infancy. However, considering the current legal system in Korea, an AI-SaMD that assists physicians' interpretation cannot be a legal subject.