The Food and Drug Administration's latest security guidance to medical-device makers reflects the growing risk hackers and malware present to the lives of hospital patients.
The FDA issued its recommendations Thursday, saying it had recently become aware of "cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations." The agency did not know of any deaths related to the incidents or of any specific devices or systems being targeted.
What the FDA found were networked medical devices infected or disabled by malware that had also been discovered in hospital computers, smartphones and tablets.
In addition, the FDA was aware of unsafe password practices for device-controlling software. The poor practices included uncontrolled distribution and the use of disabled and hard-coded passwords.
Other problems that posed a risk to patients included the failure to quickly patch software vulnerabilities in medical devices.
For years, security researchers have been exposing vulnerabilities in medical equipment, such as patient monitors, imaging devices and drug pumps. What has changed is the growing interconnectedness of these devices, as they are attached to medical networks that span intensive-care units, hospital rooms and operating theaters.
Because medical networks are often connected to the Internet, this has left all attached hardware vulnerable to malware launched by hackers most likely looking to steal Social Security numbers and other patient data. Such information is useful in impersonating someone else during criminal activity.
"Medical identity theft is a big issue," said Mustaque Ahamad, a professor and cybersecurity expert at the Georgia Institute of Technology.
The FDA guidelines for manufacturers call for stronger authentication requirements in software and timely deployment of patches and updates to applications and firmware. In addition, equipment should have "fail-safe modes" in which the device's critical functionality is not affected when security is compromised.
To encourage the fixing of vulnerabilities in devices already in use, the FDA guidelines include a note saying the agency "typically does not need to review or approve medical device software changes made solely to strengthen cybersecurity."
The recommendations should help manufacturers avoid unnecessary delays in getting network-connected devices approved, a process that takes from six months to a year, said Matthew Neely, director of research and development at SecureState, which has done penetration testing on medical equipment.
As a next step, Neely would like to see the FDA issue more robust guidelines. "Instead of general guidance, they should come up with stricter standards around what security requirements need to be in place," Neely said. "Then build a process to make sure that people are actually coding to those standards and developing devices to those standards."
The FDA began knuckling down on software quality in medical devices last year after finding that nearly a quarter of recalls were due to a software failure. At the time, the agency said its Office of Science and Engineering Laboratories would dedicate more time testing software quality and security to reduce the failure rate.
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