Food and Drug Administration Response Planning for a Networked Medical Device Compromise

Networked medical devices, including dialysis machines, pacemakers, radiology systems, and medication dispensing systems, pose a growing threat to the security and privacy of personal health information and the safety of patients. Such networked devices use hardware, software, and networks to monitor a patient's medical status, regulate bodily functions, and transmit and receive related data. The complexity and task performed by networked devices has increased exponentially over time. To meet the new demands within networked device functionality, wireless, Internet, and network connectivity has been introduced along with new cybersecurity vulnerabilities. Food and Drug Administration is responsible for ensuring and monitoring the safety and effectiveness of networked medical devices. We will examine the Food and Drug Administration's plans and processes for timely communicating and addressing a networked medical device cybersecurity compromise.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Completed	Food and Drug Administration	Food and Drug Administration Response Planning for a Networked Medical Device Compromise	Office of Audit Services	A-18-16-30530; W-00-17-42020	2018