The FDA's Center for Devices and Radiological Health and the Department of Homeland Security's (DHS's) Office of Cybersecurity and Communications announced that they will engage in a collaborative partnership to address medical device cybersecurity by coordinating and sharing information.

“As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients,” FDA Commissioner Scott Gottlieb, MD, said in a prepared statement. “The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns. But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone.”

Per the agreement, the DHS will continue to spearhead efforts relating to medical device vulnerability coordination and will consult with the FDA regarding technical and clinical matters in relation to medical devices. The expectation is that the collaboration will “lead to more timely and better responses to potential threats to patient safety” and increasing coordination efforts when vulnerabilities occur.

The agencies have previously collaborated on cybersecurity vulnerability disclosures, which help device manufacturers respond to threats quickly. Additionally, both agencies collaborated on the overall development and execution of DHS-led drills that mimic real-world cybersecurity threats, thus enabling government agencies to learn from the exercise and better prepare for such threats. These efforts will continue to be implemented as part of the agreement.

“DHS has some of the top experts on control systems technology, and we look forward to continuing to leverage this expertise for the sake of improving the lives and safety of people across the country,” Christopher Krebs, undersecretary for the National Protection and Programs Directorate at DHS, said in the same statement. “DHS has enjoyed a great working relationship with the FDA for several years and look forward to this agreement making that working relationship even stronger and more effective.”