open source medical software

[Robin 'Roblimo' Miller]

>On the other hand, I have not yet given up on the open-source
>dream. I can see that the licensing issues are mostly orthogonal to
>the FDA requirements (although perhaps not entirely so).
>

And there is still no reason for you to give up the open source dream.

Consider:

1) You allow anyone who wants to use of modify your code to do so and 
use some or all of it for any purpose whatsoever under the usual GPL 
rules, including sharing source code for any modifications they distribute.

2) You create the MedUitlity Consortium (hypothetical name) that assumes 
a role equivalent to Linus Torvalds' in  Linux development and only 
allows approved modifications to make their way into the packages(s) 
distributed under the MedUtility name the same way Linus only allows 
certain modifications into the OS kernel called "Linux."

What seems to have been forgotten in this whole discussion is that while 
open source users are allowed -- even encouraged -- to modify code, 
there is no obligation on the part of a project's leaders to accept 
those modifications and include them in the project's "official" 
versions of the software.

Naturally, you only present the official versions of MedUtility to the 
FDA for approval. And there is no rule that says you must release 
official, certified updates any more often than your consortium deems 
necessary.

If someone wants to fork your code and create VeterinaryUtility, fine. 
Perhaps they'll come up with modifications you'll later incorporate into 
MedUtility. And VeterinaryUtility, which is not subject to FDA approval, 
can have releases every other day -- and at 6 a.m. if they want to 
release not only often but early -- while MedUtility only releases new, 
approved versions every two years.

What you're doing here is using your *copyrighted name* to protect the 
integrity of the consortium-backed (and presumably FDA approved) version 
of MedUtility while preserving software freedom.

Your other concern is easily rectified by requiring all who want to 
download and use MedUtility to sign or check a disclaimer stating that 
they're aware that in some countries it may be illegal to use this 
software for treatment of humans  unless you hold an appropriate 
professional license, and that it is the user's responsibility to comply 
with applicable licensing requirements. This disclaimer shouldn't 
interfere with the GPL; it doesn't in and of itself limit use of the 
code, and doesn't hamper its use in places that don't have U.S. levels 
of medical regulation.

- Robin 'Roblimo' Miller