OIG recommends FDA enhance medical device cybersecurity review process
The Department of Health and Human Services Office of Inspector General yesterday the Food and Drug Administration take additional steps to integrate cybersecurity into its premarket review process for medical devices. Specifically, OIG recommends the agency use pre-submission meetings with manufacturers to address cybersecurity concerns, and include cybersecurity documentation and criterion on the checklists and template used to guide reviews and screen them for completeness. In comments in the report, the agency agreed with the recommendations. AHA has encouraged FDA to improve medical device security.
Related News Articles
Headline
There have been 8,064 reported cases of whooping cough in the U.S. so far this year, according to the latest data from the Centers for Disease Control and…
Headline
A study published April 17 by BMC Infectious Diseases found increased incidents of Acinetobacter baumannii and carbapenem-resistant A. baumannii infections…
Headline
The Cybersecurity and Infrastructure Security Agency April 17 released guidance to reduce risks associated with a reported breach of Oracle cloud services.…
Headline
The National Counterintelligence and Security Center, the FBI, and the Defense Counterintelligence and Security Center yesterday released guidance on…
Headline
The incidence of invasive group A strep infections increased from 3.6 to 8.2 cases per 100,000 people from 2013 to 2022, according to a study authored by the…
Headline
The AHA Living Learning Network is launching the Quality Exchange, a virtual collaborative for health care quality and patient safety professionals at…