14 DAY TRIAL // Last week, the US Food and Drug Administration (FDA) released a guide for the industry and FDA staff on how these medical devices should be designed, tested and used to make sure they’re not only safe and reliable, but also secure.
Security researchers have often warned that medical devices, particularly wireless medical devices, can always become a target for cybercriminals and the consequences could be devastating.
Back in June, the FDA released guidelines to assist the industry in identifying issues related to cybersecurity that manufacturers should take into consideration before submitting medical devices.
Now, the FDA wants to make sure wireless medical devices are not introduced into the marketplace before being properly tested.
“It is essential that manufacturers first consider and test potential limitations of the wireless connectivity associated with their devices to prevent malfunctions that could harm patients,” Bakul Patel, a senior policy advisor in FDA’s Center for Devices and Radiological Health, noted in a blog post on the FDA’s website.
“There are many factors to consider. For example, is there enough bandwidth (the range of available frequencies) available? In an environment crowded with different kinds of wireless devices, is there a possibility that interference could critically affect the device’s function?”
In the new report, the FDA recommends that wireless medical devices use security mechanisms such as wireless encryption, data access controls.
Manufacturers are advised to make sure their products benefit from protection against unauthorized wireless access to device data and control, and software protection for control of data transmission.
“Use of the latest up-to-date wireless encryption is encouraged. Any potential issues should be addressed either through appropriate justification of the risks based on your device’s intended use or through appropriate design verification and validation,” the report reads.
The complete guidance document is available on the FDA’s website.