16 October 2018 - As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. FDA and the U.S. Department of Homeland Security 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. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said 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. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important. Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the health care sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk.”

Read FDA press release