October 1, 2014 by Alexander Soule
The FDA asks medical device manufacturers to submit documentation about controls they have in place to mitigate the threat of hackers accessing their devices, including ongoing software patches and updates to operating systems.
The FDA is asking medical device manufacturers to submit documentation about cybersecurity controls they have in place to mitigate the threat of hackers accessing devices, including ongoing software patches and updates to operating systems.
The FDA issued the recommendations in a document to be released in full Thursday titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” after having released a draft version last June. On Tuesday, the agency stated it found no indication that specific devices or systems have been purposely targeted by hackers, but remains concerned about device-related cybersecurity vulnerabilities.
“There is no such thing as a threat-proof medical device,” Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health, said in prepared remarks. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”