In an alert posted last week, the FDA noted that many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.
In addition, as medical devices are increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of cybersecurity breaches, the FDA said.
The FDA said it has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations, including:
• 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;
• Failure to provide timely security software updates and patches to medical devices and networks and to address related vulnerabilities in older medical device models;
• 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/SQL injection.
"The FDA is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time," the alert said.
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