[논문]SaMD의 사이버보안 규제에 대한 소프트웨어 국제표준의 적용 가능성에 대한 연구

김이영; 정영주; 류규하; 조백환

doi:10.9716/kits.2023.22.4.021

[국내논문] SaMD의 사이버보안 규제에 대한 소프트웨어 국제표준의 적용 가능성에 대한 연구
A study on the Applicability of Software International Standards for SaMD's Cybersecurity Regulation 원문보기

한국IT서비스학회지 = Journal of Information Technology Services, v.22 no.4, 2023년, pp.21 - 35

김이영 (성균관대학교 삼성융합의과학원) , 정영주 (성균관대학교 삼성융합의과학원) , 류규하 (성균관대학교 삼성융합의과학원 의료기기산업학과) , 조백환 (차의과학대학교 의학전문대학원 정보의학교실)

Abstract ▼ AI-Helper

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.

주제어

표/그림 (10)

그림 [Figure 1] The Number of AI/ML Enabled SaMD Approved by FDA Per Year
표 Select Design Principles for consideration in Medical Device Design, Principles and Practices for Medical Device Cybersecurity (IMDRF)
표 Select Design Principles for consideration in Medical Device Design, Principles and Practices for Medical Device Cybersecurity (IMDRF) (Continued)
표 Comparison between Software standard ISO/IEC 25022:2016 and Medical Device Standard IEC 62366-1:2015, IEC 62366-2:2016
표 Comparison between Software standard ISO/IEC 25022:2016 and Medical Device Standard IEC 62366-1:2015, IEC 62366-2:2016 (Continued)
표 Comparison between Software Standard ISO/IEC 25023:2016 and Principles and Practices for Medical Device Cybersecurity (IMDRF)
표 Comparison between Software Standard ISO/IEC 25023:2016 and Principles and Practices for Medical Device Cybersecurity (IMDRF) (Continued)
표 Comparison between Software Standard ISO/IEC 25023:2016 and Principles and Practices for Medical Device Cybersecurity (IMDRF) (Continued)
표 Applicability simulation of Software Standard ISO/IEC 25023:2016 with Virtual SaMD Product: Product A (DTx), Product B (VR), Product C (CDSS)
표 Applicability simulation of Software Standard ISO/IEC 25023:2016 with Virtual SaMD Product: Product A (DTx), Product B (VR), Product C (CDSS) (Continued)

참고문헌 (12)

International Medical Device Regulators Forum？(2013, December 9) Software as a Medical？Device (SaMD): Key Definitions, page 4,？IMDRF/SaMD WG/N10[1]. Retrieved from？https://www.imdrf.org/documents/software-medical-device-samd-key-definitions.？
International Organization for Standardization？(ISO), IEC 62304:2006 Medical device software - Software life cycle processes.？
International Organization for Standardization？(ISO), IEC 62366-1:2015 Medical devices -？Part 1: Application of usability engineering？to medical devices.？
International Organization for Standardization？(ISO), IEC 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices.？
International Organization for Standardization？(ISO), ISO 13485:2015 Medical Devices -？Quality Management Systems.？
International Organization for Standardization？(ISO), ISO 14971:2019 Medical devices -？Application of risk management to medical？devices.？
International Organization for Standardization？(ISO), ISO/IEC 25010:2011 Systems and？software engineering - Systems and software Quality Requirements and Evaluation？(SQuaRE) - System and software quality？models.？
International Organization for Standardization？(ISO), ISO/IEC 25022:2016 Systems and？software engineering - Systems and software quality requirements and evaluation？(SQuaRE) - Measurement of quality in use.？
International Organization for Standardization？(ISO), ISO/IEC 25023:2016 Systems and？software engineering - Systems and software Quality Requirements and Evaluation？(SQuaRE) - Measurement of system and？software product quality.？
United States Food and Drug Administration (US？FDA) (2017, December 6), What are examples of Software as a Medical Device?？https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device？Accessed February 6, 2023.？
United States Food and Drug Administration (US？FDA) (2022, April 8), Cybersecurity in？Medical Devices: Quality System Considerations and Content of Premarket Submissions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions Accessed April？12, 2023.？
United States Food and Drug Administration (US？FDA) (2022, October 5), Artificial Intelligence and Machine Learning (AI/ML)-Enabled？Medical Devices. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices？Accessed February 6, 2023.？

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