As software is becoming more and more integral part of Medical Devices, new opportunities arise from their networking and data exchange. But this is also exposing them to the same risks as common objects such as laptops and smartphones, i.e. unauthorized access to the device.
Although the FDA “is not aware of any patient injuries or deaths associated with cybersecurity incidents, nor [is] aware that any specific devices or systems in clinical use have been purposely targeted” (see. FDA on Cybersecurity in Medical Devices), the Agency is revamping the following guidance documents related to device security:
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