August 15, 2018

Reference Number: 18-108099-160

In recent years, there has been a dramatic increase in the level of interconnectedness and data exchange between medical devices and their network environments. Increased connectivity in medical devices can: improve access to health care information; facilitate more timely diagnoses and treatments; and, improve access to care for patients. However, it can leave medical devices vulnerable to unauthorized access in a manner similar to computer systems. These vulnerabilities can impact the safety of the medical device by affecting clinical operations, causing diagnostic errors, or causing direct harm to patients.

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