Chad Waters via plug on 12 May 2022 10:11:45 -0700


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Re: [PLUG] Medical Open Source Problem, Nvidia open source



> Our Medical Devices' Open Source Problem – What Are the Risks?
>
> https://www.bleepingcomputer.com/news/security/our-medical-devices-open-source-problem-what-are-the-risks/
>
> But OSS also comes with its own set of risks that device manufacturers
> must address while leveraging its many advantages, because when it comes
> to the medical devices our lives depend on, a data breach or a system
> crash is nothing to sneeze at.

Medical device security is my wheel house. I can go on forever on the subject, but I'll type up a quick primer:

Managing the software components within medical device is a challenge for manufacturers regardless of the license.  

There has a movement for a "software bill of materials" (SBOM) for devices that was originally championed at the NTIA (Dept of Commerce) https://www.ntia.doc.gov/SoftwareTransparency It has since moved over to CISA https://www.cisa.gov/sbom 

The tool advertised in this article is focused on managing software components. Generating SBOMs seems to be a key function.

Healthcare and medical devices have been been the on the forefront of the movement with proof of concept collaboration between manufacturers and healthcare providers.

The are a few SBOM formats out there
SWID (NIST)- https://nvd.nist.gov/products/swid
SPDX (Linux Foundation)- https://spdx.dev/
CycloneDX (OWASP) - https://cyclonedx.org/

SBOMs are making their way into laws and regulations- 

May 12, 2022 - Executive order on security that among other things requires SBOMs for federal procurement 
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/05/12/executive-order-on-improving-the-nations-cybersecurity/

April 2022 - The FDA released a *draft* of the "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"... the security requirements to get a medical device. SBOMs are included in those requirements. They also appeared in a previous draft in 2018(?)

April 2022 - the Patch Act the was introduced to bolster healthcare IT security that includes SBOM for medical devices.

There’s a lot if anyone is interested.
-Chad



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