The US Food and Drug Administration released guidance last week in which it suggested that medical-device manufacturers consider the dangers of hacking in the design of their products, while not requiring countermeasures.
The nine-page document informs companies of the agency’s “current thinking” on the topic of cybersecurity. In it, the FDA recommended that companies assess any dangers on the intentional or unintentional misuse of a device in their design stage. In addition, medical devices and systems should detect and log attacks and allow technicians to react to such attacks, whether through patching a vulnerability or other action.
“The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information,” the agency stated, adding that “manufacturers should address cybersecurity during the design and development of the medical device, as this can result in more robust and efficient mitigation of patient risks.”
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