The heat is officially on medical device manufacturers and healthcare organizations to better secure and protect patient care equipment and systems from cyber attacks with new proposed best practices from the Food & Drug Administration (FDA) and proposals from a grassroots security industry group.
The FDA, late last week, issued draft guidelines for medical device makers that call for cyber threat intelligence-sharing via Information Sharing Analysis Organizations and ISACs, vulnerability disclosure and remediation programs, as well as other security best practices. Meanwhile, the I Am The Cavalry group, yesterday, published the "Hippocratic Oath for Connected Medical Devices," which aims to make medical device makers secure their equipment and healthcare providers to ensure they purchase secure equipment and secure it accordingly.
"Better patient care is the goal for everyone" here, says Beau Woods of I Am The Cavalry, whose Hippocratic Oath riffs off the traditional physician's oath to put patient care and safety first. "There are cyber-safety side effects … The Hippocratic Oath for medical devices attempts to join the ethics of care providers to deliver care in the best interest of the patient with methods and practices of cybersecurity."
Both documents were among the hot topics at the FDA's public workshop today on collaborative approaches to cybersecurity in medical devices.
Michael Murray, director of product development security for GE Healthcare, says healthcare is part of critical infrastructure and therefore requires requisite security protections. "From the presidential Executive Order around critical infrastructure protection [and] all the way to grassroots efforts like I Am The Cavalry, industry has realized the importance of security protections for critical infrastructure," says Murray, who is attending the FDA workshop in Washington, DC.
"Healthcare is no different: in fact, Suzanne Schwartz [of the FDA] pointed out in her opening comments that healthcare is the 'largest attack surface for critical infrastructure,'" Murray says.
The FDA's new draft guidelines call for medical device manufacturers to monitor and fix vulnerabilities and security problems in their products, according to Schwartz. "All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities—some we can proactively protect against, while others require vigilant monitoring and timely remediation," Suzanne Schwartz, associate director for science and strategic partnerships and acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health, said in a statement.
Security researchers for years now have been uncovering security flaws in medical devices such as insulin pumps, raising concerns of tampering and potential physical threats to patients. The latest draft recommendations for medical device-makers isn't the FDA's first foray into this space: in the fall of 2104, the agency issued recommendations to manufacturers about considering cybersecurity in the design of their products and submitting plans for patching and updating those systems. The agency in 2013 warned of the dangers of cyberattacks on medical equipment.
The FDA's draft guidance, which is open for public comment for the next 90 days, is all about proactive planning and assessment of vulnerabilities. Risk management is a key piece of the puzzle, and timely response to vulnerabilities that are reported in these products. The FDA cites the NIST Framework for Improving Critical Infrastructure Cybersecurity as a key component, as well as monitoring and testing for flaws and risk; setting up a vulnerability disclosure policy and program; and deploying mitigations, for example.
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"The guidance is aimed at how manufacturers are supposed to handle vulnerabilities in products that are already in the market," GE's Murray says. "The focus is on how manufacturers assess those vulnerabilities and respond to them, as well as their coordination along those lines with the FDA."
I Am The Cavalry's Woods applauds the FDA's guidelines, which he says encompasses the lifecycle of the products, starting with the design phase. "The first thing that stood out for me are the incentive structures" for building security into medical device manufacturers' processes and products, he says.
For instance, the FDA doesn't require manufacturers to report in advance to the agency each and every bug that's discovered in their products; "routine updates or patches" are exempt from that. "For a small subset of cybersecurity vulnerabilities and exploits that may compromise the essential clinical performance of a device and present a reasonable probability of serious adverse health consequences or death, the FDA would require medical device manufacturers to notify the Agency," the recommendations say.
I Am The Cavalry's recommendations, meanwhile, are similar to the five-star cybersecurity safety recommendations that I Am The Cavalry devised for automakers to protect cars from hacking. They include cyber safety by design; third-party collaboration for vulnerability reporting; forensics and analysis from incidents; resilience and containment of devices; and efficient and timely security updates.
"I think that all of the efforts to get security people, medical device manufacturers and healthcare payers/providers in the same room talking about how to work together to improve the security of the healthcare ecosystem is a positive development," Murray says.