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This chapter covers security and privacy considerations for AI/ML-enabled medical devices. We will begin by examining a typical hospital IT questionnaire, which is necessary to obtain approvals for the on-site deployment of such devices. Then we present the crucial topics of encryption and medical data management for multi-party accesses. Next, we review the regulations for AI/ML as they pertain to medical data and devices both in the EU and the US. We present a detailed review of the documentation required for security and privacy in the medical devices. We cover the newly emerging domain of GenAI and the security risks inherent in large language models. Lastly, we conclude by discussing the risks posed by legacy medical devices with outdated operating systems.

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Security and Privacy for AI/ML-Enabled Medical Devices

  • 章节

  • 发表日期：

    2026年

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  • Ajit Pandey,
  • Pramod Gupta,
  • Naresh Kumar Sehgal

摘要

This chapter covers security and privacy considerations for AI/ML-enabled medical devices. We will begin by examining a typical hospital IT questionnaire, which is necessary to obtain approvals for the on-site deployment of such devices. Then we present the crucial topics of encryption and medical data management for multi-party accesses. Next, we review the regulations for AI/ML as they pertain to medical data and devices both in the EU and the US. We present a detailed review of the documentation required for security and privacy in the medical devices. We cover the newly emerging domain of GenAI and the security risks inherent in large language models. Lastly, we conclude by discussing the risks posed by legacy medical devices with outdated operating systems.