FDA issues warning on cybersecurity of medical devices

In a safety communication, the FDA is recommending that medical device manufacturers and healthcare facilities "take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, 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."

The June 13 notice said 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, which could affect how a medical device operates.

The notice said the agency has become aware recently 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, 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 was not aware of any patient injuries or deaths associated with these incidents nor did it have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.

The FDA has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified.

Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, said the notice, including risks related to cybersecurity, and they are responsible for putting appropriate mitigations in place to address patient safety and assure proper device performance.

The FDA expected medical device manufacturers to take appropriate steps to limit the opportunities for unauthorized access to medical devices. "Specifically, we recommend that manufacturers review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise of the security of the hospital network that may be connected to the device. The extent to which security controls are needed will depend on the medical device, its environment of use, the type and probability of the risks to which it is exposed, and the probable risks to patients from a security breach."

The notice offered considerations for both medical device companies and healthcare facilities to limit unauthorized device access and to evaluate network security. Read the complete notice for more information.