Security News

FDA Approves Use of New Tool for Medical Device Vulnerability Scoring
2020-10-22 15:11

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.

FDA Issues Alert on Medical Device IPnet Vulnerabilities
2019-10-01 19:18

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"...

FDA Warns of Potentially Fatal Flaws in Medtronic Insulin Pumps
2019-06-28 15:14

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.

Medtronic cardiac implants can be hacked, FDA issues alert
2019-03-25 17:39

Two serious flaws in the telemetry protocol could allow a hacker to control vulnerable Implantable Cardioverter Defibrillators (ICDs).

Groups Ask FDA to Rethink Some Medical Device Cyber Proposals
2019-03-20 18:33

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....

Analysis: FDA's Reworked Premarket Medical Device Guidance
2018-11-13 16:33

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...

FDA Reacts to Critique of Medical Device Security Strategy
2018-11-07 20:03

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...

How to Use FDA's Medical Device Cybersecurity 'Playbook'
2018-10-26 19:03

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...

FDA Calls for 'Cybersecurity Bill of Materials' for Devices
2018-10-19 19:48

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...

FDA Warns of Flaws in Medtronic Programmers
2018-10-15 17:39

A vulnerability in the software update process of certain Medtronic Programmer models has determined the vendor to block the functionality on affected devices, the U.S. Food and Drug...