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FDA cites need to protect equipment from cyberattacks

Thursday June 13, 2013
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Medical device manufacturers and healthcare facilities should ensure appropriate safeguards are in place to reduce the risk of failure due to cyberattack, according to the FDA.

Such an attack could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.

"Recently, the FDA has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations," according to a safety communication from the agency.

Devices and operations that may be affected include:

• 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 or hard-coded passwords for software intended for privileged device access (such as for 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.

What to do

Healthcare facilities should take protective steps that include:

• Restricting unauthorized access to the network and networked medical devices;

• Making certain appropriate antivirus software and firewalls are up-to-date;

• Monitoring network activity for unauthorized use;

• Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services;

• Contacting the specific device manufacturer about any potential cybersecurity problem related to a medical device. If unable to determine or contact the manufacturer, the FDA and the Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team may be able to assist in vulnerability reporting and resolution;

• Developing and evaluating strategies to maintain critical functionality during adverse conditions.

Read the full safety communication: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm356423.htm.


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