FDA Guidance on Cyber Security

The Federal Food and Drug Administration (FDA) has updated its guidance on cyber security for medical devices and health care networks. Per these new recommendations, the FDA is asking that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of mishaps due to a cyber attack.

Many medical devices contain configurable, embedded computer systems that can be vulnerable to cyber security 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 cyber security breaches. The FDA is placing significant responsibility on manufacturers to ensure security based on concerns stemming from a recent series of incidents. So far, the FDA is unaware of any specific negative outcomes to patients or cases in which specific devices or systems have been targeted. It is clear, however, that vulnerabilities exist in current medical devices and networks. The FDA has been working closely with other federal agencies and manufacturers to identify communicate and mitigate vulnerabilities and incidents as they are identified.

They list the following situations 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; and
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a cyber security event has impacted the performance of a medical device or has impacted a hospital network system, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA is advising that manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cyber security, and are responsible for putting appropriate measures in place to address patient safety and assure proper device performance.

For providers, the FDA is recommending that you take steps to evaluate your network security and protect your health care system. In evaluating network security, hospitals and health care facilities should consider:

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 cyber security 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.

For complete details, please refer to the FDA Safety Communication: Cyber Security for Medical Devices and Hospital Networks website.

Contact: Patrick Cucinelli, pcucinelli@leadingageny.org, 518-867-8827