Medical devices have become more popular and advanced as they become increasingly connected. This has great benefits but also presents cybersecurity risks. These risks can affect performance and availability/integrity of the device and data it provides. In worst cases, these attacks directly affect patient lives. At best the negatively affect hospital operations. The CDRH is primarily responsible for ensuring that medical devices are both effective and safe.
In the past, the industry focused on the quality and safety risks of the devices as standalone devices relative to the patient’s health. As a result, cybersecurity risk wasn’t given much attention. However, various cyberattacks on healthcare industries resulted in a wakeup call to begin focusing on medical devices in terms of devices of the network. Nowadays, shareholders of various devices are encouraged to work with the FDA to generate cyber solutions for the sake of a global public health concern.
