@article{ART003148650},
author={Bae, Doo Hwan and Lee Sangmook and Ko Kwang Man and Do Hyeun Kim},
title={A Study of Validation Standard based on IEC 823041 for Health Software Product Safety},
journal={Journal of Software Assessment and Valuation},
issn={2092-8114},
year={2024},
volume={20},
number={4},
pages={291-301}
TY - JOUR
AU - Bae, Doo Hwan
AU - Lee Sangmook
AU - Ko Kwang Man
AU - Do Hyeun Kim
TI - A Study of Validation Standard based on IEC 823041 for Health Software Product Safety
JO - Journal of Software Assessment and Valuation
PY - 2024
VL - 20
IS - 4
PB - Korea Software Assessment and Valuation Society
SP - 291
EP - 301
SN - 2092-8114
AB - 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..
KW - Health software;Product Safety;Health Application;Stability;Validation
DO -
UR -
ER -
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man and Do Hyeun Kim. (2024). A Study of Validation Standard based on IEC 823041 for Health Software Product Safety. Journal of Software Assessment and Valuation, 20(4), 291-301.
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man and Do Hyeun Kim. 2024, "A Study of Validation Standard based on IEC 823041 for Health Software Product Safety", Journal of Software Assessment and Valuation, vol.20, no.4 pp.291-301.
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man, Do Hyeun Kim "A Study of Validation Standard based on IEC 823041 for Health Software Product Safety" Journal of Software Assessment and Valuation 20.4 pp.291-301 (2024) : 291.
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man, Do Hyeun Kim. A Study of Validation Standard based on IEC 823041 for Health Software Product Safety. 2024; 20(4), 291-301.
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man and Do Hyeun Kim. "A Study of Validation Standard based on IEC 823041 for Health Software Product Safety" Journal of Software Assessment and Valuation 20, no.4 (2024) : 291-301.
Bae, Doo Hwan; Lee Sangmook; Ko Kwang Man; Do Hyeun Kim. A Study of Validation Standard based on IEC 823041 for Health Software Product Safety. Journal of Software Assessment and Valuation, 20(4), 291-301.
Bae, Doo Hwan; Lee Sangmook; Ko Kwang Man; Do Hyeun Kim. A Study of Validation Standard based on IEC 823041 for Health Software Product Safety. Journal of Software Assessment and Valuation. 2024; 20(4) 291-301.
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man, Do Hyeun Kim. A Study of Validation Standard based on IEC 823041 for Health Software Product Safety. 2024; 20(4), 291-301.
Bae, Doo Hwan, Lee Sangmook, Ko Kwang Man and Do Hyeun Kim. "A Study of Validation Standard based on IEC 823041 for Health Software Product Safety" Journal of Software Assessment and Valuation 20, no.4 (2024) : 291-301.