SaMD의 사이버보안 규제에 대한 소프트웨어 국제표준의 적용 가능성에 대한 연구

A study on the Applicability of Software International Standards for SaMD’s Cybersecurity Regulation

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.