The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk. 
 
The guidance builds on the framework that FDA established in its earlier guidance, finalized in 2014, for helping manufacturers consider cybersecurity in the design and development of their medical devices. 
 
“Today’s draft premarket cybersecurity guidance provides updated recommendations for device manufacturers on how they can better protect their products against different types of cybersecurity risks, from ransomware to a catastrophic attack on a health system,” said FDA Commissioner Scott Gottlieb, M.D. “Because of the rapidly evolving nature of cyber threats, we’re updating our guidance to make sure it reflects the current threat landscape so that manufacturers can be in the best position to proactively address cybersecurity concerns when they are designing and developing their devices.” 
 
FDA also said it will host a public workshop Jan. 29-30 to discuss the newly released draft guidance, which will bring together diverse stakeholders for an in-depth discussion to obtain feedback on the draft guidance.
 
In related news, yesterday, FDA and the Department of Homeland Security announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices. AHA has repeatedly asked FDA to strengthen its activities to improve medical device security, and earlier this year AHA voiced support for an FDA plan to improve medical device security that included revised pre-market guidance. 

Related News Articles

Headline
The Health and Public Health Sector Coordinating Council, a public-private partnership, yesterday released a crisis response guide to help health care…
Headline
The Healthcare and Public Health Sector Coordinating Council, a public-private partnership developed to mitigate threats to the nation’s health care sector,…
Headline
China and its proxies have been observed attempting to identify and illicitly obtain valuable intellectual property and public health data related to vaccines…
Headline
The Department of Homeland Security and the Cybersecurity and Infrastructure Security Agency have updated their telework guidance to include new guidance on…
Headline
Cyber actors have launched phishing campaigns against first responders, initiated denial-of-service assaults against government agencies and threatened medical…
Headline
The FBI warned today of specific COVID-19-themed email phishing campaigns targeting U.S.-based medical providers. The campaigns leverage email subject lines…