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FDA's bill of materials creates a cybersecurity blind spot for medical devices


From: InfoSec News <alerts () infosecnews org>
Date: Thu, 10 Oct 2019 07:56:31 +0000 (UTC)

https://www.healthcareitnews.com/news/fda-s-bill-materials-crates-cybersecurity-blind-spot-medical-devices

By Bill Siwicki
Healthcare IT News
October 09, 2019

The FDA’s cybersecurity bill of materials has major implications – both good and bad – for healthcare provider organizations’ IT and security teams.

While it may seem like a no-brainer to allow manufacturers access to update their own firmware in medical devices to improve cybersecurity, opening the door to devices introduces a conflicting set of challenges.

The draft bill of materials guidance is aimed at having manufacturers disclose other vendors’ software they may be using in addition to their own software/firmware. The intent is to give the IT security staff more context on the device software.

(On a related note, the FDA has issued a safety communication – aimed at healthcare organizations, IT professionals, device manufacturers and patients – warning of the cybersecurity vulnerabilities known as URGENT/11. The risk, FDA officials said in the communication, is that URGENT/11, if exploited by a remote attacker, could pose safety and security risks for connected medical devices and hospital networks.)

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