In this chapter, the reader will learn about cybersecurity from the perspective of the medical device manufacturer, where key phases of a medical device’s lifecycle will be examined. Further, with there being a need to focus beyond securing devices and data at the deployment phase, the reader will be encouraged to look past individual medical devices and to consider third-party elements, as well as manufacturing tools and systems used in the design, deployment, and sustaining of a medical device. Similarly, the reader will be presented with a discussion associated with government and international regulations/standards and reasons for following regulations and standards. And lastly, the reader will be provided with an in-depth examination of the most recently released IEEE/UL standard, which has been recognized for its forward-looking perspective on how to identify cybersecurity risks, protect medical devices, and ensure the secure continuous use of medical solutions.

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Device Security & Standards

  • William Harding,
  • Andreas Hartmann,
  • Shayla O’Brien,
  • Viktor Sinzig,
  • Gabriel Break,
  • Natalie Sinzig

摘要

In this chapter, the reader will learn about cybersecurity from the perspective of the medical device manufacturer, where key phases of a medical device’s lifecycle will be examined. Further, with there being a need to focus beyond securing devices and data at the deployment phase, the reader will be encouraged to look past individual medical devices and to consider third-party elements, as well as manufacturing tools and systems used in the design, deployment, and sustaining of a medical device. Similarly, the reader will be presented with a discussion associated with government and international regulations/standards and reasons for following regulations and standards. And lastly, the reader will be provided with an in-depth examination of the most recently released IEEE/UL standard, which has been recognized for its forward-looking perspective on how to identify cybersecurity risks, protect medical devices, and ensure the secure continuous use of medical solutions.