Gunawardhana and Horn Review FDA Role in Medical Device Cybersecurity for FDLI Update

Shook Of Counsel Sonali Gunawardhana and Associate Margaret Horn have authored “Medical Device Cybersecurity: How the US Food and Drug Administration and Other Stakeholders Are Collaborating to Increase Patient Safety,” published in the April/May 2019 issue of the FDLI Update. 

Although connected medical devices enhance the ability of health care providers to treat patients and improve outcomes, the authors say manufacturers, hospitals and other health care entities have to work together to manage their security risks. Hacking may not only expose providers to the risks of system damage or ransomware, but may also put patient health at risk. 

The authors review the efforts of the U.S. Food and Drug Administration (FDA) to develop safety plans and work with partner agencies, including the Federal Communications Commission, to establish a regulatory framework that will still foster further development of connected medical devices. The article notes that FDA also is working with the Department of Homeland Security to address cybersecurity threats and attacks. 

In “a departure from the way FDA has traditionally approached a growing regulatory issue,” the authors note that FDA is encouraging stakeholders to participate in DEF CON’s^® Biohacking Village later this year in order to work collaboratively with cybersecurity researchers. This year’s conference will include a technical scenario built by the California Cybersecurity Institute at Cal Poly and run by Mayo Clinic, in which participants will work to defend a hospital under siege from malicious hackers. 

“FDA appears to truly appreciate the importance of continued collaboration due to the ever changing cybersecurity landscape,” the authors conclude. “We believe it is safe to say that cybersecurity issues will remain a steadfast challenge due to the continued use of legacy devices in various healthcare delivery systems as well as the introduction of novel interconnected medical devices to provide better and more efficient healthcare for patients.”

FDLI has graciously granted permission to Shook to allow our visitors to view the article.