Ransomware attack as a contributing factor

A German woman died with “ransomware attack” as a contributing factor in preventing her from receiving timely care. Media reports indicate that it may be the first death directly linked to a cyberattack on a hospital.  Apparently the closest hospital was under the ransomware attack and could not receive the emergency patient causing the first responders to travel to a more distant hospital.  The woman tragically died en route.

Cybersecurity experts have warned for years that hospitals are inadequately prepared for these attacks, despite health care being one of the biggest targets.  More than ever, hospitals have become reliant on devices that are connected to the internet. Even with redundant backup systems in place, staff are not always trained proficiently enough to quickly  transition to these systems should an attack occur. Even attacks on systems that handle patient data, but don’t directly impact medical devices, can have an adverse effect on patient care as hospital resources must be diverted for extended periods to handle those issues.

An online article is available at:  https://www.technologyreview.com/2020/09/18/1008582/a-patient-has-died-after-ransomware-hackers-hit-a-german-hospital/

In 2019 we posted: Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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