The US Food and Drug Administration has released a set of guidelines it wants medical device manufacturers to follow to reduce cybersecurity risks endemic in the market. In an effort to prevent hackers from accessing patient records, the FDA is asking that all devices manufactured by companies such as Medtronic or Johnson & Johnson, which make implanted cardiac devices, be designed with encryption so The new guidance suggests that maintenance downtime could be responsible for some cybersecurity attack vectors, saying "it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle.”
The US Food and Drug Administration has released a set of guidelines it wants medical device manufacturers to follow to reduce cybersecurity risks endemic in the market. In November 2015, the regulatory agency issued an official warning notice about security threats in medical devices connected to a network. The new guidance suggests that maintenance downtime could be responsible for some cybersecurity attack vectors, saying "it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle.”