Ch 18 Managing Medical Devices within a Regulatory Framework

What is it about?

The implementation of electronic health records, increased concern for patient confidentiality, changes in how mobile stand-alone devices that store personal health information are developed, and networked devices has elicited a steadily increasing focus on medical device cybersecurity and their software. This section discusses the important and wide span role of regulations relating to vulnerable medical device subsystems and the challenges that various stakeholders face across the total product life cycle from original equipment manufacturers, software developers, device user facilities and mobile technology. We provide various solutions from industry, academia, and government regulations to guide stakeholders (e.g., risk management, quality management, clinical engineering, and developers) that are responsible for mitigating cyber threats.

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