US agencies to bolster cybersecurity of medical devices
The US Food and Drug Administration (FDA) has announced that it has partnered with the US Department of Homeland Security (DHS) as part of the FDA’s aim to strengthen cybersecurity in healthcare.
The government agencies released the news on Tuesday, October 16.
Scott Gottlieb, commissioner of the FDA, said: “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.”
He explained that addressing modern challenges such as this cannot be achieved by one government agency alone, and the collaboration with the DHS will place the FDA in a strong position to proactively respond when vulnerabilities are identified.
Under the agreement, potential or confirmed medical device vulnerabilities will be shared between the agencies, leading to more timely responses to threats to patient safety.
The “memorandum of agreement” is intended to facilitate a greater coordination and cooperation in addressing cybersecurity challenges pertaining to medical devices.
Christopher Krebs, undersecretary for the national protection and programs directorate at DHS, said that the ability to identify, address, and mitigate vulnerabilities in medical devices is a “top priority” for the department.
“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,” he added.
Under the terms of the agreement, the DHA will continue to act as the central medical device vulnerability coordination centre and the FDA will provide technical and clinical expertise regarding medical devices.
The two agencies have already worked together on many aspects of medical device cybersecurity.
For example, they have arranged for cybersecurity researchers to provide manufacturers with information on vulnerabilities in their products, enabling all parties to respond to threats in a timely manner.
According to the press release, “this kind of coordination and information-sharing can ultimately help protect patients who rely on life-saving medical devices".
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