January 22, 2015 Articles

Bringing the Cyber War to the Medical Device Battleground

By Karen Woodward and Mary Beth Buckley

With rapid advances in medical technology, including an increasing number of wireless, Internet- and network-connected, interoperable medical devices, the Food and Drug Administration (FDA) has strongly encouraged all stakeholders, and in particular manufacturers, to take steps to ensure the cybersecurity of such devices. And, while the path to the fail-safe cybersecurity of these devices may be long and complex, the FDA and stakeholders have shown their commitment to achieving the optimal security sought by the FDA. This article discusses the FDA’s current cybersecurity guidance, the hurdles and challenges identified by stakeholders, and likely next steps for the FDA and the medical device community. 

Premium Content For:
  • Litigation Section
Join - Now