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Designing Security into Medical Device Software

Considerable effort in the development of medical devices is focused on safety and reducing patient risk. Even so, with the recent increased connectivity of devices, security researchers have found security lacking in medical devices, with one recent example finding over 1400 security vulnerabilities in a commonly-used infusion pump.

As a reaction to this troubling trend, the Federal Drug Administration (FDA) has issued guidance on managing security in medical devices. This paper discusses how to refocus medical device development to include security as a key factor, in addition to safety.