医疗设备和医院网络的网络安全

Many medical devices contain configurable embedded computer systems that can be vulnerable to cyber-security breaches. 除了, 因为医疗设备越来越多地通过互联网相互连接, 医院网络, 其他医疗设备或智能手机, 网络安全漏洞的风险正在增加, 哪些因素会影响医疗设备的运作.

The Food and Drug Administration (FDA) has recently become aware of cyber-security vulnerabilities and incidents that could directly impact medical devices or hospital network operations, 例如:

• 网络连接/配置的医疗设备被恶意软件感染或禁用
• 医院电脑上存在恶意软件, 智能手机和平板电脑, 目标是使用无线技术访问患者数据的移动设备, 监测系统和植入病人设备
• 不受控制的密码分发, 禁用密码, 用于特权设备访问的软件的硬编码密码(例如.g.、行政、技术及维修人员)
• Failure to provide timely security software updates and patches to medical devices and networks and to address related vulnerabilities in older medical device models (legacy devices)
• Security vulnerabilities in off-the-shelf software designed to prevent unauthorized device or network access, 例如明文或不进行身份验证, 硬编码的密码, documented service accounts in service manuals and poor coding/SQL injection.

FDA建议/行动

The FDA Has a number of recommendations to mitigate the risks that technology may pose to health care organizations.

对于所有设备制造商:

Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, 包括网络安全风险, and are responsible for putting appropriate mitigations in place to address patient safety and ensure proper device performance.

The FDA expects medical device manufacturers to take appropriate steps to limit the opportunities for unauthorized access to medical devices. 具体地说, it is recommended that manufacturers review their cyber-security practices and policies to ensure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise the security of the hospital network that may be connected to the device. The extent to which security controls are needed will depend on the medical device, 使用环境, 它所面临的风险的类型和可能性, 以及安全漏洞可能给病人带来的风险.

在评估您的设备时，请考虑执行以下操作:

• 采取措施限制只有受信任的用户才能访问未经授权的设备, particularly for those devices that are life-sustaining or could be directly connected to 医院网络.
• 适当的安全控制可能包括用户身份验证, 例如用户ID和密码, 智能卡, or biometrics; strengthening password protection by avoiding 硬编码的密码 and limiting public access to passwords used for technical device access; physical locks; card readers; and guards.
• Protect individual components from exploitation and develop strategies for active security protection appropriate for the device’s use environment. 这种战略应包括及时部署常规部队, validated security patches and methods to restrict software or firmware updates to authenticated code. The FDA typically does not need to review or approve medical device software changes made solely to strengthen cyber security.
• 使用保持设备关键功能的设计方法, 即使在安全受到威胁的情况下, 被称为“故障安全模式”.”
• Provide methods for retention and recovery after an incident where security has been compromised.
• Cyber-security incidents are increasingly likely and manufacturers should consider incident response plans that address the possibility of degraded operation and efficient restoration and recovery.

卫生保健设施:

The FDA recommends that you take steps to evaluate your network security and protect your hospital system. 评估网络安全, 医院和卫生保健机构应考虑采取以下措施:

• Restricting unauthorized access to the network and networked medical devices
• Making certain that appropriate antivirus software and firewalls are up to date
• 监控未经授权使用的网络活动
• Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services
• 联系ing the specific device manufacturer if you think you may have a cyber-security problem related to a medical device
  • If you are unable to determine the manufacturer or cannot contact the manufacturer, FDA也许能够协助漏洞报告和解决方案.
• Developing and evaluating strategies to maintain critical functionality during adverse conditions

向FDA报告问题 

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a cyber-security event has impacted the performance of a medical device or has impacted a hospital network system, 通过MedWatch提交自愿报告, FDA安全信息和不良事件报告项目. 

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

This Risk Insights is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel or an insurance professional for appropriate advice. 设计©2013 Zywave, Inc. 版权所有.