Medical device businesses have been able to develop devices that provide better treatments, more precise diagnoses, increased data reporting capabilities, and overall better patient monitoring because to technological advancements in and around the sector.
随着网络攻击变得更加普遍和复杂，许多行业专业人员担心医疗设备的潜在安全风险。Let’s take a closer look at three of the most pressing concerns in medical device security today, as well as three potential solutions for avoiding a cyber disaster.
安全挑战：设计没有网络安全的医疗设备：
尽管医疗设备应该是安全的，但它们通常具有网络安全功能，例如防火墙，两因素身份验证或入侵检测。Even if the device or software isn’t used to store any patient information, hackers may consider devices with weak security as a way to obtain access to huge healthcare databases and hospital systems.
监管机构正在努力解决这些安全我ssues with medical devices. following the discovery of a vulnerability that might possibly allow hackers to manipulate the quantity of insulin given, the FDA issued a warning about a line of insulin pumps in 2019.
解决方案：设计控制和FDA网络安全指南
Security best practises must be used in the design of connected devices. this is why the FDA issued two guideline documents to assist producers in achieving this goal during the premarket phase：
The FDA has provided a non-exhaustive list of methods manufacturers might improve medical device security protections:
- 两因素身份验证
- Restricting unauthorized access to medical devices
- Implement firewalls that are both adequate and up-to-date
- Monitoring network activity for unauthorized use
- 禁用所有不必要的端口和服务
- 如果适当的话，可以识别现成的软件。
- Virus protection when necessary
- Encryption of sensitive data.
SECURITY CHALLEGE: INTEROPERABILITY OF MEDICAL DEVICES AND REPLICATION CYBERATTACKS
当黑客从链接到网络（也称为节点）的一个设备中窃取关键凭据和安全密钥时，他们可以使用该信息来访问该网络上的所有其他设备。With each additional stakeholder and device, the chance of this increasing exponentially.
解决方案：库存管理系统和网络细分
在设备上方面，可以使用两项重要的安全措施来对抗复制攻击。跟踪设备和人员是检测将成为黑客可能利用的安全缺陷的强大工具。
独特的设备指标（UDI）是购买者获得自己库存管理系统帮助的好方法。
虚拟LAN，它使用简单的权限逻辑在开关级别和子网中划分流量，该子网在IP级别限制和控制流量。将它们分解为适当的分组，应该使可视化更加简单。
安全挑战：最新基于软件的医疗设备
任何软件产品的寿命都必须包括安全修复程序。在升级医疗设备软件方面，赌注明显大于笔记本电脑或智能手机等非医疗设备。在极端情况下，网络安全失误可能会导致患者受伤甚至死亡。
如果对起搏器的软件更新会导致设备离线或失败，那可能是致命的。对于更新失败的低风险设备也是如此，这可能导致诊断或治疗不正确。
SOLUTION: REGULATORY CONTROLS
在市场后监管措施方面，制造商再次成为承担责任的人。The documents ofPost market Management of Cybersecurity in Medical Devices.
The FDA recommends that manufacturers create complete cybersecurity risk management strategies and follow all documented best practises outlined in this advisory 21 CFR Part 820 QSR. We have best experienced team who can guide you in documentation as per the requirement of21CFR第820部分QSR。它还需要记录的网络安全风险管理计划，以遵守行业标准，例如ISO 30111。
选择安全QMS解决方案非常重要，这可能有助于您设计风险较小的更安全的医疗设备。网络攻击者攻击患者的数据和客户记录，制造商必须在整个医疗设备的生命周期中确保最佳的设计和文档管理系统。
188金宝搏网站靠谱吗医疗设备监管咨询拥有最有经验的团队，他们将协助您实施最佳和要求组织的QMS。升级软件时，不仅需要遵守规则；制造商必须在软件验证期间进行彻底的风险评估，并为每次分发更新。
