[Please keep Ira Kalet and the Debian Med mailing list in CC]
Hello,
I'm forwarding a part of a discussion to you legal experts for
clarification:
On Thu, Jul 31, 2014 at 11:15:49AM -0700, Ira Kalet wrote:
> >
> >>3. Finally, there is still the issue of what the US FDA might say
> >>about distribution within the US, as software products that do what
> >>Prism does are considered medical devices and cannot be distributed
> >>without FDA 510K premarket approval, an onerous process to be sure.
> >>It does not matter that no money is involved. What do you do about
> >>other debian-med packages? Might any of them be considered a
> >>medical device?
> >
> >I'm not aware that we have a comparable case. From my admittedly naive
> >point of view distribution wise it does not matter whether the program
> >is distributed from your web site or in addition from the Debian
> >mirrors. There was a time when Debian was maintaining a specific non-US
> >archive containing crypto stuff that was covered by some US export law
> >but this was a long time ago and all crypto software is included in
> >Debian. However, if you want to know for sure I might forward this
> >question to the debian-legal list.
> >
>
> By all means, please check with any legal resources you might have.
> My UW web site is source only, and in order for anyone to use the
> code, they have to learn Lisp, and understand Prism well enough to
> build a running system. I believe this takes it out of the realm of
> "product". A package that can be installed by just clicking, that
> results in a complete runnable radiation therapy planning system
> might be considered by the FDA a real "product". I don't really
> know for sure.
>
> Also there is a disclaimer on my web site that might not satisfy the
> Debian policy requirements that I read. It says that the software
> is provided for research and study. The license does not legally
> restrict its use in a clinical application, though other such
> systems, such as PLUNC from Univ. of North Carolina do include such
> restrictions in their license agreement. Maybe it could just go
> into the non-free area.
What do you think?
Kind regards and thanks for any advise
Andreas.
--
http://fam-tille.de
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