On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”2 Less than three weeks later―after the recent surge in reported data breaches at several large corporations―media sources broke the story that the Department of Homeland Security (DHS) is investigating a different type of vulnerability: cybersecurity flaws in medical devices and hospital equipment. These flaws include security vulnerabilities that could lead to death or serious injury, as well as exposure to civil lawsuits or government investigations should such harms befall the public.

DHS’s Investigation

According to media reports, the DHS’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) is investigating approximately two dozen potential security vulnerabilities in medical devices that may be exploitable by cyber criminals.3 ICS-CERT began examining technical vulnerabilities in medical devices about two years ago, based on a cybersecurity researcher’s concerns that networked medical devices were susceptible to malicious hacking. A DHS source was quoted saying that “[i]t isn’t out of the realm of the possible” that medical device security vulnerabilities could “cause severe injury or death.”4

Media sources report that ICS-CERT has identified software bugs and/or vulnerabilities in both infusion pumps and implantable heart devices. While no deaths or serious injuries resulting from cybersecurity vulnerabilities have yet been reported, DHS is concerned that malicious actors could exploit these bugs to gain control over the devices.  In response to these concerns, ICS-CERT has been working proactively with medical device manufacturers to identify areas of exposure and mitigate risks before any medical devices or hospital equipment are attacked or protected health information or confidential data is stolen.5

Sources within DHS have apparently acknowledged that its probe is based in part on the research of Barnaby Jack, a recently deceased cybersecurity expert. Jack was well known for stating that he could hack into the wireless communications system that links implanted pacemakers and defibrillators with bedside monitors. Jack demonstrated a serious medical device cybersecurity vulnerability when, at a 2012 conference in Melbourne, he demonstrated that he could remotely cause an implanted pacemaker to deliver an 830-volt shock.6 Similarly, Billy Rios, a private cybersecurity researcher, claims to have identified a bug in a popular implanted infusion pump, and to have developed a program that allows him to remotely control the pump and administer lethal doses of drugs to patients.7

Despite experts’ assurances to patients with networked medical devices, at least one public figure―former Vice President Dick Cheney―has disabled some of the networking features of his implanted defibrillator, fearing that cyber terrorists could exploit those features.  In response to questions about his decision to go off-line, Cheney explained that he was in a “relatively unique circumstance[]” as a former Vice President; however, others remain wary and some have even followed Cheney’s lead in disabling network access on their medical devices.8

October 2, 2014 Final FDA “Nonbinding” Cybersecurity Guidance

The public notice of ICS-CERT’s two-year investigation underscores the timeliness and relevance of the FDA’s most recent guidance—issued October 2, 2014, at the start of Cybersecurity Awareness Month—to medical device manufacturers on cybersecurity, which is available here. The FDA guidance, consisting of “nonbinding recommendations” ostensibly modeled on the NIST Cybersecurity Framework, encourages manufacturers to develop controls to ensure the security of medical devices with the capability of connecting to the Internet, other devices, or other networks. For an in-depth discussion of the FDA guidance, please see the King & Spalding Client Alert available here.

The guidance encourages manufacturers to treat security measures as a fundamental part of the developmental process.  It also acknowledges that device makers face challenges in striking the balance between implementing effective cybersecurity safeguards and ensuring that devices remain usable in their intended settings. Striking this balance is particularly important in the medical field, where physicians and other personnel often need to act with extreme urgency in emergency situations. The guidance sets forth examples of security functions for device manufacturers to consider, including limiting network access to the device through authentication protocols, implementing automatic timers to terminate sessions after a period of time, strengthening password protections, placing physical locks on devices, restricting software or firmware updates, and adding features that detect, log, and respond to security compromises.

The FDA also recommends including certain documentation as part of the premarket submission process to ensure implementation of appropriate cybersecurity controls. This documentation includes a hazard analysis, a summary of controls, and a “traceability matrix” that “links [] actual cybersecurity controls to the cybersecurity risks that were considered” by the manufacturer. Notably, on October 29, 2014, the FDA is holding a webinar on the Final Guidance called “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”

Our reliance on technology to safeguard some of our most important data―or, in the case of medical devices, to keep us alive―has led to an increase in the number of reported cyber attacks, the value of the data that has been compromised in these attacks, and the level of sophistication of cyber criminals.  It is only a matter of time before malicious hackers target networked medical devices. Manufacturers can best prepare for, and react to, these attacks by considering the importance of cybersecurity in every step of the device development process, remaining vigilant to developing threats, and responding quickly to attacks.