Cybersecurity for Medical Devices

von itsbusiness AG

Cybersecurity is a topic of increasing concern for medical devices, from accessing and changing parameters maliciously, to theft of patient data or introduction of malware into wider medical systems. Older medical devices may not have updated cyber security which leaves them open to cyberattacks.

There are key standards for cybersecurity and medical devices and following these will mitigate the risks of cyberattack:

ISO 14971: Medical Devices - Application of Risk Management to Medical Devices

Purpose: Focuses on risk management throughout the lifecycle of a medical device, including considerations for cybersecurity risks.

Application: Manufacturers use ISO 14971 to identify, assess, and mitigate risks associated with medical devices, with a growing emphasis on cybersecurity risk in the evolving healthcare landscape.

IEC 62304: Medical Device Software - Software Life Cycle Processes

Purpose: Specifically addresses software lifecycle processes for medical device software, emphasizing safety and effectiveness. (IEC 62304)

Application: Provides a framework for developing, maintaining, and updating software in medical devices, with considerations for cybersecurity to prevent vulnerabilities.

ISO/IEC 27001: Information Security Management System (ISMS)

Purpose: Establishes a systematic approach to managing information security, including cybersecurity aspects.

Application: Organizations, including those manufacturing medical devices, use ISO/IEC 27001 to build and maintain a robust information security management system, addressing cybersecurity risks.

ISO/IEC 27002: Code of Practice for Information Security Controls

Purpose: Provides a set of guidelines for implementing specific security controls, complementing ISO/IEC 27002.

Application: Offers detailed security control recommendations that can be applied to enhance the cybersecurity posture of medical devices and associated systems.

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