A Study of Validation Standard based on IEC 823041 for Health Software Product Safety (IEC 82304 기반 헬스 소프트웨어 제품 유효성 확인 표준 연구)

Doohwan Bae (배두환); Sangmook Lee (이상묵); Kwang-Man Ko (고광만); Do-Hyeun Kim (김도현)

doi:10.29056/jsav.2024.12.29

A Study of Validation Standard based on IEC 823041 for Health Software Product Safety

Journal of Software Assessment and Valuation
Abbr : JSAV
2024, 20(4), pp.291~301
DOI : 10.29056/jsav.2024.12.29
Publisher : Korea Software Assessment and Valuation Society
Research Area : Engineering > Computer Science
Received : December 5, 2024
Accepted : December 20, 2024
Published : December 31, 2024

Doohwan Bae ¹, Sangmook Lee ¹, Kwang-Man Ko ², Do-Hyeun Kim ³

¹제주대학교 관관경영학과
²상지대학교 컴퓨터공학과
³제주대학교

Accredited

ABSTRACT

Health software products are designed by manufacturers to help individuals manage, maintain, improve, or treat their health. Some health software may pose hazardous situations. Therefore, all health software requires risk management procedures. For health software that may contribute to hazardous situations, risk controls are necessary to prevent hazards or the likelihood of hazard occurrence. Testing the final product alone is not sufficient to address the safety of health software. This paper present a process requirements for health software development based on IEC 82304 are necessary. This IEC 82304 standard aims to provide requirements for the safety and security of health software products, specifically for standalone software products. The requirements of this standard apply to software that affects such health parameters and/or to software whose security breaches compromise the privacy or confidentiality of health and welfare information..

KEYWORDS

Health software, Product Safety, Health Application, Stability, Validation

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* References for papers published after 2024 are currently being built.

[confproc] Kim, Y. / 2019 / Study on the Regulation of Medical Devices Software and the Demand of Medical Device Developers / Proceeding of the Institute of Electronics and Information Engineers : 1005~1008

[journal] Song, G. T. / 2018 / Recent research trends in smart medical devices and ICT convergence medical industry / The Journal of The Korean Institute of Communication Sciences 35(6) : 50~55

[web] / 2016 / IEC 82304-1:2016 Health software – Part 1: General requirements for product safety / IEC / https://www.iso.org/standard/59543.html

[web] / 2021 / IEC 82304-2:2021 Health software – Part 2: Health and wellness apps — Quality and reliability / IEC / https://www.iso.org/standard/78182.html

[journal] Noh, S. C. / 2011 / A Study of Security QoS(Quality of Service) Measurement Methodology for Network Security Efficiency / Convergence Security Journal 11(1) : 39~48

[book] Konschak, C. B. / 2011 / Consumer-Centric Healthcare:Opportunities and Challenges for Providers / Health Administration Press

[book] Adelstein, F. / 2005 / Fundamentals of mobile and pervasive computing (Vol. 1) / McGraw-Hill

[confproc] Venkatasubramanian, K. K. / 2006 / Security for pervasive health monitoring sensor applications / 2006 Fourth International Conference on Intelligent Sensing and Information Processing / IEEE : 197~202

[web] / 2019 / ISO 14971:2019(Medical devices ? Application of risk management to medical devices) / IEC / https://www.iso.org/standard/72704.html

[other] MFDS / 2019 / Guidelines for Permit and Review of Medical Devices with Big Data and Artificial Intelligence (AI) Technology / MFDS

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Journal of Software Assessment and Valuation 2024 KCI Impact Factor : 0.32

A Study of Validation Standard based on IEC 823041 for Health Software Product Safety

ABSTRACT

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Citation status

* References for papers published after 2024 are currently being built.

Journal of Software Assessment and Valuation 2024 KCI Impact Factor : 0.32

A Study of Validation Standard based on IEC 823041 for Health Software Product Safety

ABSTRACT

KEYWORDS

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