As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration 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. 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.”
“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. “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. 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.”
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 two agencies have already worked together on many aspects of medical device cybersecurity, most notably around coordination of vulnerability disclosures. This helps medical device manufacturers receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products in a way that enables all parties to respond to potential threats in a timely way. The agencies have also collaborated on planning, executing and conducting after-action reviews of DHS-led exercises that simulate real-world cybersecurity attacks and enable the government and stakeholders to practice and improve their responses to these threats. The goal of the agreement is to expand these types of collaboration by increasing the sharing of information between the two agencies to enhance mutual awareness of potential or known threats, thereby heightening coordination when vulnerabilities are identified. And to enhance shared technical capabilities, such as conducting collaborative assessments regarding the level of risk a potential vulnerability may pose to patient safety and coordinate testing of devices as warranted.
Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. The DHS’ National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA, particularly in the event of cybersecurity vulnerabilities in medical devices that are identified to the Department of Homeland Security. The FDA will continue to engage in regular, ad hoc, and emergency coordination calls with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities.
The agreement formalizes a long-standing relationship between the FDA and DHS. 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. This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices.
The FDA promotes and protects the public health by ensuring the safety, efficacy, and security of medical products, including medical devices. The agency has taken significant steps to create an environment of shared responsibility between government agencies, industry, healthcare delivery organizations and cybersecurity researchers. Interconnected devices increase cybersecurity risks which, if exploited, may affect device performance. The agency is committed to enhancing patient safety by mitigating cybersecurity risk throughout the life cycle of medical devices, which includes monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they are on the market.
The DHS mission includes preventing terrorism and enhancing security; managing U.S. borders; administering immigration laws; securing cyberspace; and ensuring disaster resilience. Information sharing is a critical part of the DHS mission to create shared situational awareness of malicious cyber activity. DHS works to prevent or minimize disruptions to critical information infrastructure in order to protect the public, the economy, and government services.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.