대한의용생체공학회:의공학회지 (Journal of Biomedical Engineering Research)

  • 제44권2호
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  • Pages.99-108
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  • 2023
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  • 1229-0807(pISSN)
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  • 2288-9396(eISSN)
대한의용생체공학회 (The Korean Society of Medical and Biological Engineering)
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인공호흡기 원격 통합 모니터링 및 제어 시스템 개발을 위한 소프트웨어 위험관리 및 사이버보안

Software Risk Management and Cyber Security for Development of Integrated System Remotely Monitoring and Controlling Ventilators

  • 정지용 (연세대학교 대학원 의료기기산업학과) ;
  • 김유림 (연세대학교 대학원 의료기기산업학과) ;
  • 장원석 (연세대학교 대학원 의료기기산업학과)
  • Ji-Yong Chung (Department of Medical Device Engineering and Management, Yonsei University, College of Medicine) ;
  • You Rim Kim (Department of Medical Device Engineering and Management, Yonsei University, College of Medicine) ;
  • Wonseuk Jang (Department of Medical Device Engineering and Management, Yonsei University, College of Medicine)
  • 투고 : 2023.02.10
  • 심사 : 2023.03.08
  • 발행 : 2023.04.30
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초록

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

키워드

과제정보

본 연구는 2020년 범부처의 연구개발비(202011B26)로 수행되었으며 이에 감사드립니다.

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