这食品和药物管理局（FDA）对医疗保健行业进行了更新的前市场网络安全指南，该指南更新了针对医疗设备制造商的网络安全建议，目的是解决脆弱性和不断发展的网络安全威胁。
这draft premarket cybersecurity guidance,医疗设备中网络安全管理的上市上提交的内容，确定与网络安全有关的问题，制造商在医疗设备的设计和开发中应解决的问题，以确保更好地保护设备免受网络安全威胁，以中断临床操作并延迟患者护理。
FDA 510 K Clearance＆Market批准医疗设备
188金宝搏网站靠谱吗操纵子策略师是FDA 510 K流程顾问，如果适用，请客户注册SBU（小型企业单位）。删除产品的测试要求，创建档案，解决查询以及完成所有活动后。
这new guidance is intended to provide recommendations to the medical device industry regarding cybersecurity device design, labelling and that FDA recommended documentation be included in pre-market submissions for devices vulnerable to cybersecurity threats. The recommendations build on the framework that the FDA created in its 2014 guidance for manufacturers.
According to the FDA, these updated recommendations also will facilitate an efficient premarket review process and help ensure that medical devices are designed to sufficiently address cybersecurity threats before the devices are on the market.
“Cybersecurity threats and vulnerabilities in today’s modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this way, we can help ensure the healthcare sector is well positioned to proactively respond when cyber vulnerabilities are identified in products that we regulate.”
“Today’s draft premarket cybersecurity guidance provides updated recommendations for device manufacturers on how they can better protect their products against different types of cybersecurity risks, from ransomware to a catastrophic attack on a health system,” Gottlieb said in his statement, noting that the rapidly evolving nature of cyber threats necessitated an updated approach “to make sure [the guidance] reflects the current threat landscape so that manufacturers can be in the best position to proactively address cybersecurity concerns when they are designing and developing their devices.”
Gottlieb说：“这是对设备安全的总产品生命周期方法的一部分，在该方法中，制造商必须充分解决从设计阶段到设备在市场上的设备网络安全的解决方案，以帮助确保患者免受网络安全的保护。”
的关注加强医疗井斜ce cybersecurity, the FDA also announced this week an协议与国土安全部一起增加有关医疗设备安全的协作。FDA设备与放射健康中心与DHS网络安全与通信办公室之间的协议旨在鼓励有关潜在或确认的医疗设备网络安全脆弱性和威胁的更大协调和信息共享。这些机构说，这种合作可以导致对患者安全的潜在威胁的更及时，更好的反应。
“Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cyber criminals who may seek to put patient lives at risk,” Gottlieb said in a statement about the partnership.
关于本周发布的指南草案，它纳入了新建议，包括“网络安全法案”，该建议是商业和/或现成的软件和/或现成的软件以及设备的硬件组件的列表，可以容易受到影响漏洞。FDA说，根据与设备相关的网络安全风险水平，此列表可以是一个重要资源，以帮助确保设备用户能够快速响应潜在的威胁。
指南草案还引入了两层设备
Those with higher cybersecurity risk, including implanted devices such as pacemakers or neurostimulation devices, and standard cybersecurity risk, which includes devices that contain software—based on potential harm to patients from cybersecurity threats. The指导草案outlines the documentation for inclusion in a premarket submission to the agency to demonstrate that the design of the medical device has adequately mitigated risk.
