Lexology November 17, 2023
The number of medical devices with wireless and network-connected capabilities continues to grow. At the same time, by some reports the number of ransomware attacks on health care facilities has more than doubled in recent years.[1] Recent cyberattacks and/or ransomware attacks on healthcare systems have resulted in stolen patient data, emergency room closures, diversion of ambulances, and cancellation of surgeries and other appointments. Given the potential disruptions in patient care in connection with these incidents, the cybersecurity of medical devices with wireless and network-connected capabilities becomes increasingly important to avoid and mitigate these possible impacts.
Against this backdrop, the Federal Food and Drug Administration (FDA) recently published its final guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content...
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