The U.S. Food and Drug Administration (FDA) has issued a communication addressing recent cybersecurity incidents affecting medical devices and hospital networks.
In a June 13 memo, the FDA said it has recently become aware of cybersecurity vulnerabilities and incidents that could directly affect medical devices or hospital network operations.
As such, 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 cyberattack. Such attacks could be initiated by the introduction of malware into medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.
Recent cybersecurity vulnerabilities that could directly affect medical devices or hospital network operations include the following:
- 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/SQL injection
The FDA noted that it's not aware of any patient injuries or deaths associated with these incidents, nor does it have any indication at this time that any specific devices or systems in clinical use have purposely been targeted.
The agency recommends that manufacturers review their cybersecurity practices and policies to ensure that appropriate safeguards are in place to prevent unauthorized access to or modification of their medical devices or compromised security of the hospital network. Hospitals should also take steps to ensure security and protect their hospital system, the FDA said.
The full communication can be accessed here.
