FDA announces actions to strengthen medical device cybersecurity

The Food and Drug Administration today released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices. Developed by MITRE Corp., the “playbook” includes steps such as developing a medical device inventory and conducting training exercises. The agency also announced two memoranda of understanding to create information sharing analysis organizations, groups of experts that will gather, analyze and disseminate information about cyber threats. “We believe this transparent sharing of information will help manufacturers address issues earlier and result in more protection for patients,” said FDA Commissioner Scott Gottlieb, M.D. AHA has repeatedly asked FDA to strengthen its activities to improve medical device security.