The agency is encouraging medical device manufacturers to evaluate their risk and take action to remediate any vulnerability.
The vulnerability could allow a remote attacker to gain access to highly sensitive systems.
URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
Long-term industry efforts are essential in closing the gaps in the device ecosystem.
Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies.
Just because your device isn’t specifically targeted by hackers doesn’t mean it isn’t vulnerable to cybersecurity threats.
The concept of adding connectivity to a medical device may be simple. The process, however, is not.