The U.S. Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) recently signed a memorandum of agreement to strengthen cybersecurity in healthcare systems and medical devices.
Together, the two agencies will seek to create greater coordination and cooperation on medical devices and their cybersecurity concerns. More information will be shared now about vulnerabilities and threats, and they hope the collaboration will lead to quicker responses, which in turn could lead to greater patient safety.
“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 said. “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. 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 healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified.”
Though the two agencies have already worked together on such security for years, this expands that unity. In addition to the greater amount of information shared, they also hope to enhance shared assessments and coordinate on device testing. DHS loses none of its role as central coordinator for medical device assessor under the arrangement, nor will the FDA cease to work with DHS on patient health and cybersecurity threats’ potential for harm to patients.
“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. “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.”