Tag Archives: U.S. Food and Drug Administration

URGENT/11 Cybersecurity Vulnerabilities Could Affect Medical Devices and Hospital Networks

On the heels of an FDA committee report concerning cybersecurity issues with medical devices [view related post] the U.S. Food and Drug Administration (FDA) issued an alert regarding cybersecurity vulnerabilities, referred to as “URGENT/11,” that could introduce risks for some medical devices and hospital networks. According to the FDA’s October 1st notice, the URGENT/11 vulnerabilities … Continue Reading

Abbott Laboratories Releases Patches for Cardiac Devices

Abbott Laboratories has issued software patches to some of its implantable cardiac devices (manufactured by St. Jude) for cybersecurity flaws and battery issues that have plagued the devices, necessitating the U.S. Food and Drug Administration (FDA) to previously issue warnings to patients about the devices [view related posts here and here]. There are more than … Continue Reading

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all parties associated with clinical research with the appropriate use of electronic health records in FDA-regulated clinical investigations, which in … Continue Reading

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant portion of these devices will be medical devices such as pacemakers, in-home monitoring systems and … Continue Reading
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