Actually this has nothing to do with open source .... it is how it is
distributed ie. sold vs. given away.
One of the best medical imaging systems in the market actually started
out as a freebie....the name escapes me now.... not sure what the FDA
history of that solution is but it spread far and wide and then became
commercial and would have had to get FDA approval at that point.
J
Greg Woodhouse wrote:
That's interesting. Frankly, I find it a bit disconcerting to think
that medical applications might be unregulated just because they are
open source.
--- Joseph Dal Molin <[EMAIL PROTECTED]> wrote:
There was a recent post on the OSIRIX list that asked the question
why
is OSIRIX not subject to FDA regs. The answer apparently is "if you
sell
it installed" it is FDA regulated .... if you give it away it is not.
I
have asked the people responsible for OSIRIX (BTW it is an open
source
medical image viewer) to give me a more detailed answer which I will
share with this list when I receive it.
Joseph
Kevin Toppenberg wrote:
I understand the need to protect one's business investments. But
it
was my understanding that the entire VI package was FOIA -- its
just
that one would need to be careful not to cross the FDA in
implementations.
So the "import API" should be open source, and the "VI background
processor" should be open source too, I suspect.
What we need are people who understand the system and can explain
it
-- or at least better than the usual documentation.
I suspect that there is money in the area on this subject and that
is
why there is a tendency towards secrecy.
Kevin
On 8/11/05, smcphelan <[EMAIL PROTECTED]> wrote:
We all know how protective the VistA Imaging people are. I cannot
share
anything I obtained because of the IA. Maybe legally I can. But I
cannot
jeopardize our relationship with Silver Springs. So we take the
most
conservative approach. The import API was released as a patch to
the MAG
package. If it is out on FOIA you have it. But it is designed to
work
with
the VI Background Processor.
----- Original Message -----
From: "Kevin Toppenberg" <[EMAIL PROTECTED]>
To: <hardhats-members@lists.sourceforge.net>
Sent: Thursday, August 11, 2005 9:36 AM
Subject: [Hardhats-members] Re: TIU Interface for Document Scanning
On 8/10/05, smcphelan <[EMAIL PROTECTED]> wrote:
...
We cannot share the import functionality with
anyone as that would be a violation of our IA with VistA Imaging.
I don't understand. If one has an IA with VistA imaging, then one
is
not allowed to share code?
Kevin
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===
Gregory Woodhouse <[EMAIL PROTECTED]>
"Design quality doesn't ensure success, but design failure can ensure failure."
--Kent Beck
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