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KMID : 1142220210160010027
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.27 ~ p.35
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A Study on Postmarket Management Method for Cybersecurity in Medical Devices
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Han Seoung-Hee
Woo Jae-Hyun
Kim Sung-Min
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Abstract
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The demand for ICT-based medical devices is gradually growing according to the global trend of the medical device market. And accordingly, the number of cyber attacks is increasing. Moreover, as the technology of cyber attack becomes more sophisticated, the extent of damage is increasing for vulnerable devices from cyber threat, like legacy devices already on the market. Therefore, the leading countries, such as the United States, Europe, and Canada are already preparing and operating postmarket management of cyber security policies. In Korea, the need for cyber security guideline in the postmarket management aspect has emerged in line with the market trend. In this study, guidelines and regulations on the postmarket management of cybersecurity in major countries were compared and analyzed with the domestic situation. Based on the analysis results, a postmarket management method of cyber security was proposed in consideration of domestic circumstances.
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KEYWORD
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Medical Device, Software, Cyber security, Post Market
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Listed journal information
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