Re: Status of uw-prism packaging for Debian
On 08/11/2014 08:03 AM, Ian Jackson wrote:
Steve M. Robbins writes ("Re: Status of uw-prism packaging for Debian"):
My guess is that the legality of distribution hinges on how the software is
represented. For example,  defines "device" as:
any article, instrument, apparatus or contrivance, including any
component, part or accessory thereof, manufactured, sold or represented
for use in
a. the diagnosis, treatment, mitigation or prevention of a disease,
disorder or abnormal physical sate, or its symptoms, in human
beings or animals,
If the software makes no claim about diagnosis or treatment, perhaps it's
still OK, as in the Osirix case.
This sounds like it could be dealt with by appropriate wording in the
Description and/or documentation (eg manpages)
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.
The way Common Lisp code is packaged in Debian appears to be most
suitable to this anyway. 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.
Sorry to have taken the time of so many people to sort this out.
If this source only strategy is OK with you all, what are the next steps?
Ira J. Kalet, Ph.D., FACMI
Professor Emeritus, Radiation Oncology
Professor Emeritus, Biomedical Informatics and Medical Education