Breakthrough Insights

Security of Medical Devices Remains a Growing Concern

With the rising amount of connected devices in circulation, the number of potential targets for hackers and other cyber criminals to exploit continues to rise. Among the most common targets for attack: medical devices.

A survey released in October of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18% of provider organizations had medical devices impacted by malware or ransomware in the last 18 months.

Medical devices were defined in the report as “biomedical devices used by healthcare-delivery organizations in the pursuit of patient care.”

The report also stated that only 39% of the respondents were “very confident or confident that their current strategy protects patient safety and prevents disruptions in care.”

Although organizations are making gains in developing and maturing their overall security programs, the report says, progress has been slow. This is particularly true when it comes to securing medical devices, the study shows. Unsurprisingly, respondents cited patient safety as their top concern with unsecured medical devices.

“Unsecured and poorly secured medical devices put patients at risk of harm if those devices are hacked,” said Russell Branzell, president and CEO of CHIME, in a press release about the report. “In recent years, that risk has increased exponentially as devices in hospitals and health organizations have become more and more interconnected.”

Adam Gale, president of Klas, also weighed in on the findings: “Safeguarding medical devices requires a joint effort by provider organizations and device manufacturers. Many providers have the basic building blocks for a general security program in place and are making progress.”

A large majority of the survey respondents (96%) identified manufacturer-related factors as a root cause of medical device security issues. The majority of respondents also reported struggles related to out-of-date operating systems or the inability to patch devices, which have been found to be major security risks. The study also discovered that, on average, one third of medical device manufacturers have said their devices cannot be patched.

“Medical device security is a three-way relationship between provider organizations, the manufacturers, and the regulators,” said Dan Czech, director of market analysis-cybersecurity at Klas, in the announcement about the findings.

Provider organizations can follow industry-accepted best practices such as network segmentation, Czech said. “Manufacturers can include security in the design of all products going forward and can consistently patch currently offered medical devices,” he said. “Regulators can provide incentives and disincentives for manufacturers and organizations to secure their devices and can offer the needed guidance to direct the healthcare industry.”

The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

“As innovation in medical devices advances and more of them are connected to hospital networks or to other devices, making sure the devices are adequately protected against intrusions is paramount to protecting patients,” said Scott Gottlieb, FDA commissioner, in the memorandum announcement.

The partnership between the two agencies will enable them to share information about the constantly evolving threats against medical devices and help organizations in the healthcare industry proactively respond when vulnerabilities are identified.

This isn’t the first time the two agencies have collaborated on medical device security. In recent years they have been focused on the coordination of vulnerability disclosures. The partnership allows device manufacturers to receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products so they can respond to potential threats in a timely way.

During medical device development, gaps and oversights introduce a variety of risks. Learn how medical device companies can identify and reduce risk during the development process, allowing more time for transformative innovation, with the Jama Connect Risk Management Center.

Author Bob Violino is a freelance writer who covers a variety of technology and business topics.