FDA Wants Medical Devices To Have Mandatory Built-In Update Mechanisms (bleepingcomputer.com)

Catalin Cimpanu, writing for BleepingComputer: The US Food & Drug Administration plans to ask Congress for more funding and regulatory powers to improve its approach towards medical device safety, including on the cybersecurity front. An FDA document released this week reveals several of the FDA's plans, including the desire to force device makers to include mandatory update systems inside products for the purpose of delivering critical security patches.

In addition, the FDA also plans to force device makers to create a document called "Software Bill of Materials" that will be provided for each medical device and will include software-related details for each product. Hospitals, healthcare units, contractors, or users will be able to consult the medical device's bill of materials and determine how it functions, what software is needed for what feature, and what technologies are used in each device.

Comments

Re:Nice try

[olsmeister]

I bet you could make a really sweet Faraday onesie... bonus points if you wear it and fight crime at the same time.

I can see the repercussions now

[nimbius]

kids: dad what happened to grandma?
dad: well kids...shes gone to a better place
mom: dad flashed a rom to her pacemaker with the wrong binary architecture
dad: Its more complicated than that kids, Grandma was one SMA antenna away from being able to route our IPv6 traffic so we can use faster fortnight servers.
kids: is grandma in heaven?

Dad: more importantly, does daddys toolchain documentation cover the insulin pump in grandpa....

Re:Nothing in the article says "remote" updates

[Jamu]

I hate to think where they put that.

Re:About time

[barakn]

Yes, I'm sure the updates will be obtained via Ham Radio. Fucking idiot.