在医疗器械的利益风险分析中考虑网络安全风险:范围审查
Oscar Freyer1, Fatemeh Jahed1, Max Ostermann1
1Else Kröner Fresenius Center for Digital Health, Dresden University of Technology, Dresden, Germany.
Journal of medical Internet research
|December 24, 2024
概括
这次审查发现,虽然医疗器械 (MD) 的网络安全风险是公认的,但仍然存在.
科学领域:
- 医疗设备 网络安全 网络安全
- 监管科学 监管科学
- 风险管理 风险管理
背景情况:
- 连接医疗设备 (MDs) 提供了好处,但也带来了重大的网络安全风险.
- 欧盟和美国的监管框架要求在MD批准的利益风险分析 (BRA) 中评估网络安全风险.
- 目前关于系统评估和将这些网络安全风险整合到BRA的指导是有限的.
研究的目的:
- 对法律框架,指导方针和标准进行范围审查.
- 确定医疗器械 (MD) 的利益风险分析 (BRA) 中如何考虑网络安全风险.
- 涵盖美国,加拿大,韩国,新加坡,澳大利亚,英国和欧盟的法规.
主要方法:
- 在10个数据库中使用PRISMA-ScR指南进行了系统的文献搜索.
- 搜索包括2024年7月和9月的"网络安全"",收益/风险"和"风险-收益"等术语.
- 从34份包含的文件 (法规,标准,报告,指南) 中提取和分析了数据.
主要成果:
- 在150份文件中,有34份符合纳入标准,包括法规,标准,技术报告和指导文件.
- 大多数文件都承认网络安全风险,但缺乏将其纳入利益风险分析 (BRA) 的详细方法.
- 没有找到BRA内部评估网络安全风险的全面和标准化方法.
结论:
- 在承认医疗器械 (MD) 中的网络安全风险和为其纳入利益风险分析 (BRA) 提供指导之间存在重大差距.
- 需要标准化框架来指导网络安全风险的评估及其对MD安全和保障的影响.
- 需要更清晰的方法来评估网络安全风险,以确保医疗器械的安全和保障.
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