In June, the U.S. Food and Drug Administration (FDA) recommended 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 a cyberattack. The Safety Communication suggests that a cyberattack could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.
According to the Safety Communication, the FDA recently became aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations. Although EMS agencies weren’t specifically mentioned in the communiqué, the FDA expressed the following concerns that could also affect EMS providers:
“¢ 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); and
“¢ Security vulnerabilities in off-the-shelf software designed to prevent unauthorized devices 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 stresses that the department isn’t aware of any patient injuries or deaths associated with these incidents, nor do they have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.
The department has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they’re identified.
The FDA is recommending that healthcare agencies take steps to evaluate network security and protect patient care records. The suggestions 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 if you think you may have a cybersecurity problem related to a medical device. If you are unable to determine the manufacturer or cannot contact the manufacturer, the FDA and DHS ICS-CERT may be able to assist in vulnerability reporting and resolution; and
“¢ Developing and evaluating strategies to maintain critical functionality during adverse conditions.
They further recommend that healthcare professionals report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, at www.fda.gov/MedWatch/report.htm1.
According to the Safety Communication, the FDA recently became aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations. Although EMS agencies weren’t specifically mentioned in the communiqué, the FDA expressed the following concerns that could also affect EMS providers:
“¢ 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); and
“¢ Security vulnerabilities in off-the-shelf software designed to prevent unauthorized devices 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 stresses that the department isn’t aware of any patient injuries or deaths associated with these incidents, nor do they have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.
The department has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they’re identified.
The FDA is recommending that healthcare agencies take steps to evaluate network security and protect patient care records. The suggestions 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 if you think you may have a cybersecurity problem related to a medical device. If you are unable to determine the manufacturer or cannot contact the manufacturer, the FDA and DHS ICS-CERT may be able to assist in vulnerability reporting and resolution; and
“¢ Developing and evaluating strategies to maintain critical functionality during adverse conditions.
They further recommend that healthcare professionals report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, at www.fda.gov/MedWatch/report.htm1.
