The U.S. Food and Drug Administration (FDA) is the latest government agency to respond to the growing concern over increasing cybersecurity threats. After security analysts alerted FDA that medical devices used in the clinical setting were vulnerable to function manipulation and/or failure due to malware and other types of cyber threats, on June 13, 2013, FDA issued an FDA Safety Communication in order to assist medical device manufacturers and health care facilities in ensuring that appropriate safeguards are in place to reduce the risk of device failure or compromise due to a cyberattack. This advisory discusses FDA’s Safety Communication and FDA’s new draft guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which describes FDA’s current thinking regarding cybersecurity features that should be developed in order to ensure that the functionality of a device is not compromised.
To read the full text of this advisory, please click on Cyber Alert: Cyber Attacks on Human Health? FDA Urges Manufacturers to Tighten Cybersecurity on Medical Devices.
Written by Kimberly Peretti, Partner, Security Incident Management & Response Team, Cathy Burgess, Partner, Health Care, Brendan Carroll, Associate, Health Care, and Louis Dennig, Associate, Litigation & Trial Practice | Alston & Bird LLP