They may be still safer than some chemicals promoted in health food stores -
or more important, consider the safety of paper records - where is FDA
there? ...thx/t

> -----Original Message-----
> From: [EMAIL PROTECTED] [mailto:hardhats-
> [EMAIL PROTECTED] On Behalf Of Greg Woodhouse
> Sent: Thursday, August 11, 2005 10:02 AM
> To: hardhats-members@lists.sourceforge.net
> Subject: Re: VistA Imaging FDA and NonCommercial Use Re: [Hardhats-
> members] Re: TIU Interface for Document Scanning
> 
> 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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