open source medical software

Kelly Anderson kelly at
Wed Feb 2 19:36:45 UTC 2005

It's probably obvious from the previous replies, but I think it's worth 
stating that you might consider breaking the project up into several 
pieces, each of which has it's own license. This can give you more 
flexibility than one license might be able to. You could get the benefit of 
open source for the parts that are perhaps more generally applicable (many 
eyes and so forth) and largely avoid the problems with the more 
specifically medical parts for the majority of users. This would increase 
the number of users for the parts that are more generally applicable, 
giving you more of the benefits of open source to your overall project.

I'm curious about something though. As I understand it, the FDA tends to 
look at "medical devices" as a whole system, hardware, software and 
processes together. Does that mean that a Computer running Linux has to be 
FDA approved prior to running an X-Ray machine with it, or examining 
X-Rays, or whatever. The point here is that if the FDA has approved 
"computers" and specifically "Linux" or "Windows XP", then there is 
precedence for how they might deal with a multi-part piece of software. 
Similarly, they may have approved the use of Oracle in a system, but maybe 
not MySQL, or maybe they have approved both. If the "base" package can get 
initial FDA approval, then it's only the smaller part (that might change 
more frequently) that would have to go through the process regularly. I 
guess my point here is to find out what the FDA has done with other open 
source projects that may have been incorporated into medical devices, 
because there had to have been one or two previous attempts. This also goes 
to the idea of separating the pieces, as a general "Baysian Engine" might 
get FDA approval on it's own more easily than the entire system.

IANAL, etc.


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