| Title |
A Study on Design of Requirements for Medical Device Cyber Security Evaluation on Digital Twin Environment |
| Authors |
서병석(Byung-Suk Seo) ; 구지현(Jee-Hyun Koo) ; 손선영(Sunyoung Sohn) ; 고광만(Kwang-Man Ko) |
| DOI |
https://doi.org/10.5573/ieie.2024.61.10.103 |
| Keywords |
Medical device; Cyber security; Software as a medical device; Digital twin |
| Abstract |
The concept of traditional medical devices has recently expanded from medical devices that include firmware and programmable logic controllers to digital medical devices that only have software. In particular, malfunctions or breakdowns in medical devices are causing fatal consequences such as serious injury, death, and permanent impairment of bodily functions. Recently, cases of cybersecurity threats such as hacking of medical devices and information leaks have been consistently reported. These threats can cause not only property damage but also direct harm to patients' lives, highlighting the importance of cybersecurity for medical devices. Medical devices must be manufactured and evaluated based on specific cybersecurity clearance and screening guidelines[1] during the entire software development process. In this paper, we present cybersecurity requirements that must be observed in medical device development and suggests ways to utilize them in a digital twin environment. In medical device development, by proactively examining cybersecurity requirements in a virtual environment such as a digital twin, effects such as shortened inspection time and cost savings can be achieved in a practical offline environment. |