I am fairly new to the group, but coming from the commercial medical
(not open-source) software development environment, I see this as
the main concern. The only way that i can see an open source medical
project getting FDA 510(K) and the like is if one lead person or group
assumes responsibility for the VAST amounts of paperwork that have
to go into it before, during and after the project. This does not even
begin to address issues such as clinical testing, etc.
How are these issues addressed in the current projects? Someone
has to assume responsibility for ultimate compliance. Perhaps the
current FDA model isn't ammenable to open-source projects. I
would appreciate some feedback, as I think that there could be a
very viable role for open-source in the medical community.
Thanks,
Arun Sivashankaran
Project Engineer
BIOMEC, Inc.
On Thu, 9 Sep 1999 [EMAIL PROTECTED] wrote:
>
>
> One topic to be pursued within such a forum is open source standardization
> and certification, e.g., for FDA or eventual HIPAA compliance. The nature
> of gov't regulations for FDA requires rather strict record-keeping which
> seems to be problematic for the open source development paradigm.
> Similarly, for security compliance -- which may well include record-keeping
> to ensure secure development practices -- how can open source contributors
> deal with that?
>
> Comments?
>
>
>
>
>
