FDA, DHS form partnership to address medical device cybersecurity

The Food and Drug Administration (FDA) and Department of Homeland Security (DHS) are joining forces to address cybersecurity for medical devices.

The agencies announced a memorandum of agreement between the FDA’s Center for Devices and Radiological Health and DHS Office of Cybersecurity and Communications on Monday, Oct. 16. The agreement pledges the departments will implement “greater coordination and cooperation” when addressing cybersecurity issues for medical devices.

The agreement is a part of an overall effort to strengthen cybersecurity in healthcare, especially as more devices are developed and connected to hospital networks. Protecting patient safety was cited as a top reason to protect devices from cybersecurity threats by the agencies. 

Cybersecurity was named as a top technology hazard for 2019 among healthcare executives.

The agreement is meant to encourage the agencies to share information about potential or confirmed medical device cybersecurity vulnerabilities and threats. Additionally, the agencies hope to be more timely and responsive to potential threats that risk patient safety.

“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,” a press release stated. “This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices.”

The FDA said it’s currently working to create a program that addresses cybersecurity threats for medical devices, but it can’t do all the work alone. It’s new partnership with DHS will serve as an effort to be proactive about device security and help healthcare providers identify and address cybersecurity risks.

“This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk,” FDA Commissioner Scott Gottlieb, MD, said in a statement.