Cybersecurity Vulnerabilities – GE Healthcare Clinical Information System

FDA is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored.  Per the FDA notice:

“A security firm has identified several vulnerabilities in certain GE Healthcare Clinical Information Center workstations and Telemetry Servers, that may allow an attacker to remotely take control of the medical device and to silence alarms, generate false alarms and interfere with the function of patient monitors connected to these devices.

These devices are used mostly in healthcare facilities for displaying patient information, such as the physiologic parameters (such as temperature, heartbeat, blood pressure) of a patient, and monitoring patient status from a central location in a facility, such as a nurse’s workstation. To date, the FDA is not aware of any adverse events related to these vulnerabilities.

These vulnerabilities might allow an attack to happen undetected and without user interaction. Because an attack may be interpreted by the affected device as normal network communications, it may remain invisible to existing security measures.”

Learn more about cybersecurity vulnerabilities related to the GE Healthcare Clinical Information System in the FDA Safety Communication issued on January 23, 2020. The document outlines important safety information and recommended actions.

Related post:  The FDA’s Role in Medical Device Cybersecurity

About the author

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

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