Product Liability Update

Originally published as a Snell & Wilmer Legal Alert, June 20, 2013

Within the last week the Food and Drug Administration (FDA) issued a pair of Safety Communications directed towards the medical device and healthcare industries regarding cybersecurity. Computer virus and other malware attacks against medical devices and hospital networks create risks of equipment performance degradation and possible failure, which could compromise patient care. While the FDA has reported no deaths or injuries thus far due to such incidents, it considers cybersecurity breaches to be “increasingly likely” and warranting pro-active counter-measures. 

The FDA cautioned in its June 13 and 17 Safety Communications, “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.” Cyberattacks causing data breach incidents involving confidential patient information have also been reported.

Concerns about medical device cybersecurity vulnerabilities are not just theoretical. In 2010, a Veterans Affairs (VA) official reported to Congress that over 122 medical devices at VA facilities had been found to be compromised by malware over the prior 14 months. Recent media accounts reports indicate that since 2009, malware had infected more than 325 devices at VA hospitals, including X-ray machines, computers used with cardiac catheterization devices, a mammography viewing machine and a gamma camera for nuclear medicine studies. In another instance, a virus reportedly caused a medical device to potentially expose sensitive patient information by sending it to outside servers, thus resulting in a data breach.

In its recent Safety Communications, the FDA now recommends that healthcare facilities and medical device manufacturers implement appropriate safeguards against malware intrusions and develop plans to mitigate the effects of such incidents.

Concerning healthcare facilities, the FDA listed several cybersecurity vulnerabilities that can 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, smartphone 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 (for administrative, technical or maintenance personnel);
• Failure to provide timely security software updates and patches to medical devices and networks, particularly in in older medical device models (legacy devices); and
• Security vulnerabilities in off-the-shelf software designed to prevent unauthorized device or network access.

In addressing these concerns, the FDA issued several recommendations for healthcare facilities:

• Restrict unauthorized access to the network and networked medical devices;
• Keep antivirus software and firewalls up-to-date;
• Monitor network activity for unauthorized use;
• Protect individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services;
• Contact the medical device manufacturer if the facility thinks it may have a cybersecurity problem related to a medical device; and
• Develop and evaluate strategies to maintain critical functionality during adverse conditions.

Cybersecurity vulnerabilities may also extend to physicians, medical groups and even insurance carriers/claims administrators if they are connected to the facility’s computer networks, absent appropriate firewalls, antivirus protection and other security counter-measures.

With regard to medical device manufacturers, the FDA noted:

• Manufacturers are responsible for putting appropriate mitigations in place to address patient safety and assure proper device performance;
• Manufacturers are expected to take appropriate steps to limit opportunities for unauthorized access or modifications to medical devices (or compromise the security of the hospital network that may be connected to the device), specifically including a review of their cybersecurity practices and policies to assure appropriate safeguards are in place;
• Manufacturers should use design approaches that maintain the device’s critical functionality, even when security has been compromised, known as “fail-safe modes”; and
• 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.

“Appropriate mitigations” include user authentication methods (user ID and password, smartcard or biometric), strengthening password protection by avoiding hard-coded passwords and limiting public access to passwords for technical device access, physical locks, card readers and guards. 

The FDA specifically encouraged manufacturers to timely deploy routine, validated security patches for medical device software or firmware and to implement methods to restrict device software or firmware updates to genuinely authenticated code. In that regard, the FDA noted that it “typically does not need to review or approve medical device software changes made solely to strengthen cybersecurity.” This pronouncement is apparently in response to a concern voiced by some manufacturers, that FDA regulations limit the changes that can be made to a device’s software.

In addition, on June 14, 2013 the FDA issued draft guidance on how manufacturers should address cybersecurity in their pre-market submissions. Previously in 2005, the FDA had issued guidance on how manufacturers should address cybersecurity issues related to products that use off-the-shelf software. 

Given the continued push towards electronic medical records and an increasingly-connected web of high-tech medical devices linked to hospital networks and the Internet, issues regarding medical device and hospital network cybersecurity are here to stay. Further guidance and other potential action from the FDA can be expected.