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
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
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 haz- ards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have seri- ous 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 man- agement and cybersecurity application.
Abstract
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 haz- ards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have seri- ous 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 man- agement and cybersecurity application.
참고문헌 (23)
- 최보윤, "STPA를 적용한 의료기기 시스템의 안전성 프로세스 가이드라인", 인터넷정보학회논문지, 22(6), pp.59~69 (2021), 한국인터넷정보학회
- 이재희, "COVID-19 시대 국내외 원격의료 동향과 의료서비스산업의 균형 성장을 위한 정책 제언", 문화기술의 융합, 6(4), pp.591~598 (2020), 국제문화기술진흥원
- 김동엽, "의료기기 소프트웨어 위험관리를 위한 개발생명주기 기반 위험관리 요구사항 연관성 분석", 정보처리학회 논문지, 6(12), pp.543~548 (2017), 한국정보처리학회[DOI]
- MFDS, "Guideline for Software Validation of Medical Devices" (2007), Ministry of Food and Drug Safety
- MFDS, "Guideline on Review and Approval of Medical Device Software" (2019), Ministry of Food and Drug Safety
- IEC, "IEC 62304, Medical Device Software-Software Life-Cycle Processes", International Electrotechnical Commission, ~ (2006)
- KISA, "Cyber Security Guide for Smart Medical Service" (2018), Korea Internet & Secuirty Agency
- 노시완, "원격 헬스케어 모니터링 시스템에서 키 격리기법을 이용한 개선된 건강정보 전송 보안 프로토콜", 멀티미디어학회논문지, 19(12), pp.1981~1991 (2016), 한국멀티미디어학회[DOI]
- Oh JM, "Policy Research on Smart Medical and ICT Convergence Security", Proceedings of the Korea Technology Innovation Society, pp.607~624 (2020)
- 신수민, "5ss5c와 Immuni 랜섬웨어의 암호화 프로세스 분석 및 복구 방안 연구", 디지털콘텐츠학회논문지, 21(10), pp.1895~1903 (2020), 한국디지털콘텐츠학회[DOI]
- 전인석, "의료산업에서의 랜섬웨어 대응 방법", 정보보호학회논문지, 28(1), pp.155~165 (2018), 한국정보보호학회[DOI]
- 김기환, "디지털헬스케어 차세대 정보보호체계수립방안에 대한 연구", 한국컴퓨터정보학회논문지, 27(7), pp.57~64 (2022), 한국컴퓨터정보학회[DOI]
- Thomasian NM, "Cybersecurity in the Internet of Medical Things", Health Policy and Technology, 10(3) (2021)
- Kim YR, "A Study on the Regulation of Medical Devices Software and the Demand of Medical Device Developers", Proceeding of the Institute of Electronics and Information Engineers, pp.1005~1008 (2019)
- Han SH, "A Study on Postmarket Management Method for Cybersecurity in Medical Devices", Regulatory Research on Food, Drug, and Cosmetic, 16(1), pp.27~35 (2021)
- MFDS, "Guideline on Review and Approval for Cybersecurity of Medical Devices", Ministry of Food and Drug Safety, ~ (2020)
- KISA, "KISA-GD-2019-0007", Korea Internet & Security Agency, ~ (2019)
- 박호준, "전자의료기기 국제규격(IEC 60601-1)에 부합한 위험관리 방법론 제안", 대한산업공학회지, 44(3), pp.215~225 (2018), 대한산업공학회[DOI]
- MFDS, "Guidelines for Risk Management of Medical devices", Ministry of Food and Drug Safety, ~ (2007)
- 임종천, "화재수신기 기반의 화재감시로봇을 위한 프로토콜 설계", 한국정보전자통신기술학회 논문지, 11(4), pp.452~459 (2018), 한국정보전자통신기술학회
- 이연식, "시스템 컨트롤러 오류 자동복구 및 리셋 알고리즘", 한국컴퓨터정보학회논문지, 25(3), pp.89~96 (2020), 한국컴퓨터정보학회[DOI]
- Chung YJ, "Untact Technology Trends Due to the Diffusion of Covid19 – A Study on the Service Robot", The Journal of the Korea Contents Association, 18(2), pp.18~23 (2020)