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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
  • Publisher : Korea Software Assessment and Valuation Society
  • Research Area : Engineering > Computer Science
  • Received : December 5, 2024
  • Accepted : December 20, 2024
  • Published : December 31, 2024

Bae, Doo Hwan 1 Lee Sangmook 1 Ko Kwang Man 2 Do Hyeun Kim 1

1제주대학교
2상지대학교

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..

Citation status

* References for papers published after 2023 are currently being built.