FDA and DHS increase coordination to medical device cybersecurity threats

Agreement will facilitate information sharing between agencies on vulnerabilities  and threats involving medical devices

PARCA eNews – Oct. 31, 2018 – The U.S. FDA 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 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, M.D. said in a press release. "But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges."

The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety.

The agreement formalizes a long-standing relationship between the FDA and DHS with both agencies 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.

Source: FDA press release