FDA cautions on devices connected to health care networks
The Food and Drug Administration (FDA) recently warned healthcare providers to build awareness of the vulnerabilities and risks associated with medical devices being increasingly connected to information systems and networks.
The FDA is recommending that medical device manufacturers and healthcare facilities take steps to ensure that appropriate safeguards are in place to reduce the risk of failure due to cyber attack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.
"Many medical devices contain configurable embedded computer systems that can be vulnerable to cyber security breaches," the FDA statement says. "In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cyber security breaches, which could affect how a medical device operates."
The FDA cites these cyber security vulnerabilities and incidents that could directly impact medical devices or hospital network operations:
- network-connected/configured medical devices infected or disabled by malware;
- the presence of malware on hospital computers, smartphones and tablets, targeting mobile devices using wireless technology to access patient data, monitoring systems, and implanted patient devices;
- uncontrolled distribution of passwords, disabled passwords, and hard-coded passwords for software intended for privileged device access (e.g., to administrative, technical, and maintenance personnel);
- failure to provide timely security software updates and patches to medical devices and networks and to address related vulnerabilities in older medical device models (legacy devices);
- security vulnerabilities in off-the-shelf software designed to prevent unauthorized device or network access, such as plain-text or no authentication, hard-coded passwords, documented service accounts in service manuals, and poor coding.
The full alert from the FDA is available online at http://tinyurl.com/paymv9u.