Re:Can I drop a pacemaker 0day?
by redthrowaway on Thursday June 05, 2014 @12:58PM
(#7852837)
That strikes me as a system that was set up with the best intentions, but which in practice acts as a barrier to, rather than facilitator of, change. The only way I can see it compelling a manufacturer to change is if someone is killed by this exploit and their family uses the existence of a report of that vulnerability to push for massive willful negligence damages in a lawsuit.
[ Parent
| on HN ]
That strikes me as a system that was set up with the best intentions, but which in practice acts as a barrier to, rather than facilitator of, change
Hu?
I can see an argument that is is ineffective (maybe it just drops into the FDA bureaucracy), but I'm not sure how you can argue it is actually a barrier?
The FDA does actually have some pretty significant regulatory authority over medical devices. IANAL, but it appears this may be one of the limited cases where the FDA may actually be able to force a recall[1] as opposed to just requesting it. I suspect (and hope) the "recall" would actually be limited to a software update in this case. Even if they can't force it, a FDA-requested recall is a pretty significant thing.
[1] http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDis...