Security News
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have issued alerts about the presence of hidden functionality in Contec CMS8000 patient...
The Common Vulnerability Scoring System was originally designed to convey the severity of vulnerabilities found in IT systems, and it may not be as relevant in some areas, such as industrial control systems or medical devices. MITRE developed the new rubric last year and the FDA announced this week that it has qualified as a Medical Device Development Tool.
Agency Warns That 11 Issues May Pose Risks to Devices, NetworksThe Food and Drug Administration has issued an alert warning healthcare organizations about 11 vulnerabilities dubbed "URGENT/11"...
The FDA sent out an urgent advisory warning of serious flaws in Medtronic's insulin pumps, which are used by thousands across the U.S.
Two serious flaws in the telemetry protocol could allow a hacker to control vulnerable Implantable Cardioverter Defibrillators (ICDs).
Agency Receives Critique on Draft of Premarket Medical Device Cyber Guidance UpdateThe FDA is generally on the right track in updating guidance for the cybersecurity of premarket medical devices....
The FDA's recently issued draft document updating its premarket medical device cybersecurity guidance originally issued in 2014 contains several important provisions, says regulatory attorney...
Watchdog Agency Cited Deficiencies, But Agency Says Many Have Already Been AddressedThe FDA's procedures for handling cybersecurity concerns in medical devices once they are on the market are...
A new "playbook" co-developed by the Food and Drug Administration and Mitre Corp. aims to assist healthcare delivery organizations in responding to cybersecurity incidents involving medical...
Food and Drug Administration Releases Draft of Updated Pre-Market Guidance for Medical DevicesBefore marketing their medical devices, manufacturers should prepare a "cybersecurity bill of...