关键词: 医疗器械, 网络安全, 漏洞库, 建设, 运营

Abstract:

Currently， cybersecurity issues have become one of the key factors restricting the development of the medical device industry. Promoting vulnerability governance and strengthening the safety management of medical devices throughout their entire life cycle is particularly important. Cybersecurity vulnerabilities are becoming an important national strategic resource. The construction and operation of a national medical device cybersecurity vulnerability database is a fundamental and strategic project in the field of medical device cybersecurity in China. It plays an irreplaceable and important role in ensuring patient life safety and privacy， maintaining medical order and social stability， and promoting the healthy development of the medical device industry. This study， based on an analysis of the current situation of medical devices cybersecurity vulnerability governance， explores the key issues and chanenges existing in the construction and operation of the national medical device cybersecurity vulnerability database， such as insufficient awareness， scattered management， limited technical means， and the technology， data， talent， and policies and regulations in the governance of cybersecurity vulnerabilities. The study systematically summarizes the principles for establishing the national medical device cybersecurity vulnerability database， including the principles of authority， completeness， accuracy， timeliness， and security. It also covers key technologies， such as vulnerability collection and verification， vulnerability analysis and evaluation， vulnerability early warning and release， and vulnerability repair and management. Additionally， the construction process is outlined， including planning and design， data collection and organization， platform construction and development， testing and optimization， and launch operation and maintenance. The operation and management model is another focus， which includes organizational structure and personnel management， vulnerability information management and services， cooperation and exchange， supervision， management， and evaluation. The aim is to build a vulnerability database platform that is authoritative， complete， accurate， timely， and secure， in order to address the threats posed by cybersecurity vulnerabilities in medical devices. At the same time， this study aims to provide theoretical support and practical guidance for the improvement of China's medical device cybersecurity protection system.

Key words: Medical devices； , Cybersecurity； , Vulnerability database； , Construction； , Operation