IPnet Cybersecurity Vulnerabilities – Urgent

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices

The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities is already publicly available.

Security researchers have identified 11 vulnerabilities, named “URGENT/11.” These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.

These vulnerabilities exist in IPnet, a third-party software component that supports network communications between computers. Though the IPnet software may no longer be supported by the original software vendor, some manufacturers have a license that allows them to continue to use it without support. Therefore, the software may be incorporated into other software applications, equipment, and systems which may be used in a variety of medical and industrial devices that are still in use today.

Read the safety notification here: https://www.fda.gov/medical-devices/safety-communications/urgent11-cybersecurity-vulnerabilities-widely-used-third-party-software-component-may-introduce?utm_campaign=2019-10-01%20URGENT%2F11%20Cybersecurity%20Vulnerabilities&utm_medium=email&utm_source=Eloqua

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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