Cybersecurity for Medical Devices

Brian Pate of SoftwareCPR® writes:
In May 2014, FDA offered further guidance to manufacturers regarding premarket submission information identifying cyber-security risks and hazards associated with their medical devices, and the responsibility for engineering appropriate risk controls to address patient safety and assure proper device performance. FDA encouraged manufacturers to report any cyber-security incidents that may occur.

Many manufacturers may be struggling with first steps toward improved cyber-security or what process to use. Since many medical device manufacturers are already familiar with the ISO 14971 risk management process, SoftwareCPR® recommends that cyber-security risks simply be added to the existing risk analysis. Using techniques such as threat modeling, cyber-intrusions can be treated like failure modes that can lead to high level hazards that have been identified for the clinical harms of the medical device. The ISO 14971 process will then guide the evaluation and design of appropriate risk controls for these types of cyber-intrusions.

Device manufacturers and healthcare institutions should also become familiar with a number of Health IT security standards – including the IEC 80001 series – that contain specific recommendations for addressing and assessing cybersecurity risks.

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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