Cybersecurity features of digital medical devices: an analysis of FDA product summaries
Cybersecurity features of digital medical devices: an analysis of FDA product summaries
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DOI：
10.1136/bmjopen-2018-025374
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发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Kramer, Daniel B.
中科院分区：
文献类型：
--
作者：
Stern, Ariel Dora;Gordon, William J.;Kramer, Daniel B.
目的为了更清楚地定义受美国食品药品监督管理局（FDA）监督的数字医疗设备的前景，该分析利用公开可用的监管文件来说明受监管医疗器械中软件和网络安全功能的流行程度和趋势。设计我们分析了来自公开可用的FDA产品摘要的数据，以了解软件和网络安全功能的纳入频率和近期趋势。设置2002-2016年批准的全套受监管医疗器械，包括在FDA的510（k）和上市前批准数据库中。主要和次要结局指标主要结局是包含在其产品摘要中包含网络安全内容的软件的器械的份额。次要结果是这些份额的差异（a）随着时间的推移和（B）跨regulations.Results监管设备，13.79%被确定为包括软件。在这些产品中，只有2.13%的产品摘要包含了研究期间的网络安全内容。近年来，包括网络安全内容的设备的总体份额更高，从我们样本的前十年的平均1.4%增长到2015年和2016年的5.5%。包括网络安全内容的设备份额在监管领域也有所不同，从0%到22.2%。结论为了确保患者和医院最安全的医疗服务环境，监管机构和制造商应共同努力，使新医疗设备的软件和网络安全内容更容易获得。
Objectives To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices.Design We analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product intonation.Setting The full set of regulated medical devices, approved over the years 2002-2016 included in the FDA's 510(k) and premarket approval databases.Primary and secondary outcome measures The primary outcome was the share of devices containing software that included cybersecurity content in their product summaries. Secondary outcomes were differences in these shares (a) over time and (b) across regulatory areas.Results Among regulated devices, 13.79% were identified as including software. Among these products, only 2.13% had product summaries that included cybersecurity content over the period studied. The overall share of devices including cybersecurity content was higher in recent years, growing from an average of 1.4% in the first decade of our sample to 5.5% in 2015 and 2016, the most recent years included. The share of devices including cybersecurity content also varied across regulatory areas from a low of 0% to a high of 22.2%.Conclusions To ensure the safest possible healthcare delivery environment for patients and hospitals, regulators and manufacturers should work together to make the software and cybersecurity content of new medical devices more easily accessible.