Hi Ira,
On Mon, Aug 18, 2014 at 01:42:51PM -0700, Ira Kalet wrote:
>
> I had the good fortune at a recent social event to meet an attorney
> for one of the big multinational corporations in the medical device
> business, whose job is to look after FDA regulatory issues. He even
> was familiar with RTP systems. He agrees with the view that if the
> Prism software is not represented as a ready-to-use device or
> system, and is only distributed as a source code library, then no
> FDA involvement should be necessary.
Thanks for your continuous effort into this.
> The way Common Lisp code is packaged in Debian appears to be most
> suitable to this anyway.
I have to admit that I do not have the slightest idea how Common Lisp is
handled in Debian and that I feel incompetent to give a sensible answer
to your question. So please take my answer with a grain of salt. It
might be best to contact the Lisp developers list[1] about Lisp details.
> Building a runnable binary is highly Lisp
> vendor specific and would be difficult to automate. But treating it
> as a library from which someone really knowledgeable could build a
> binary on their own would be relatively easy. I would support this.
In general a Debian package tries to deliver a ready to run program (if
this is the nature of the software and if it is not just a library).
However, I'm not only Lisp-illiterate I have only a very vague
imagination what Prism finally is and how use cases of this software
really look like. So it might perfectly be that the term "library" fits
better than a ready to run program.
BTW, in the consequence of our discussion another idea popped up in my
mind. I have no idea whether this is possible but are there chances
that a patient suspects some mistake in calculating radiations and might
go to court and sue the person / hospital claiming they might have
caused some harm to him. Is there any chance that this will fire back
to Debian / the Debian maintainer in some way? If there would be a
chance for this we should be quite carefully in wording the description
for a potential prism package.
For instance to declare the program (library?) only fit for "educational
use" or something like this. In case we should decide for such a means
I guess we would be done also with FDA issues since we are not shipping
a device but rather a program to demonstrate something for educational
purposes. (If people might use it for real calculations anyway - that's
their problem.)
What do you think about this?
> Sorry to have taken the time of so many people to sort this out.
Well, sometimes it needs careful discussion to create a system which can
be used in health care. I do not think that this was extraordinary long
discussion compared to the complexity of the problem.
> If this source only strategy is OK with you all, what are the next steps?
As far as I understood previous mails of yours we need some
preconditions for prism in Debian anyway. What about simply starting
with packaging these preconditions. Even if we might finally decide
that we do not deliver a prism binary package (but just provide
packaging stuff to make it simple creating a Debian package with very
less effort) we can turn Debian into a system where it is brain dead
easy to install Prism onto. Perhaps it is a good idea to contact the
Lisp developers via their mailing list[1] how to start with these Lisp
preconditions.
Hope this helps and thanks for your effort
Andreas.
[1] http://lists.alioth.debian.org/pipermail/pkg-common-lisp-devel/
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