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FDA and DHS to Increase Collaboration and Better Coordinate Efforts to Improve Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) have announced a memorandum of agreement to implement a new framework to increase collaboration and improve coordination of their efforts to increase medical device security.

The security of medical devices has long been a concern. Cybersecurity flaws in medical devices could potentially be exploited to cause patients harm, and with an increasing number of medical devices now connecting to healthcare networks, it is more important than ever to ensure adequate protections are in place to ensure patient safety and threats are rapidly identified, addressed and mitigated.

Medical devices are a potential weak point that could be exploited to gain access to healthcare networks and sensitive data, they could be used to gain a foothold to launch further cyberattacks that could prevent healthcare providers from providing care to patients. Vulnerabilities could also be exploited to deliberately cause harm to patients. While the latter is not believed to have occurred to date, it is a very real possibility.

Both the FDA and DHS are aware of the threat posed by medical devices and have working to strengthen cybersecurity. The two agencies have collaborated in the past on medical device cybersecurity and vulnerability disclosures, although the new agreement formalizes the relationship between the two agencies.

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The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” explained FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone.”

Under the new agreement, information sharing will be increased between the two federal agencies to improve understanding of new medical device security threats. When vulnerabilities are discovered, both departments will work closely together to assess the risk that the vulnerabilities pose to patient safety. The agencies will also coordinate the testing of the vulnerabilities.

By working more closely together, the two agencies will be able to eliminate duplication of activities and will be able to work more efficiently at identifying and mitigating threats. “Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks,” wrote the FDA.

DHS will remain as the central coordination center for medical device vulnerabilities through the National Cybersecurity and Communications Integration Center (NCCIC), which will continue to be responsible for coordinating information sharing between medical device manufacturers, security researchers and the FDA.

The FDA’s Center for Devices and Radiological Health will use its considerable technical and clinical expertise to assess the risk vulnerabilities pose to patient health and the potential for patients to come to harm from exploitation of vulnerabilities. This information will then be shared with DHS through regular, ad hoc, and emergency communication calls.

“Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS.

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.