" <[EMAIL PROTECTED]>
> To:
> Sent: Friday, August 12, 2005 10:44 AM
> Subject: [Hardhats-members] RE: VistA Imaging FDA and NonCommercial Use Re:
> [Hardhats-members] Re: TIU Interface for Document Scanning
>
> >> Still,
> >> our FDA approval process has
ject: Re: [Hardhats-members] RE: VistA Imaging FDA and NonCommercial Use
Re: [Hardhats-members] Re: TIU Interface for Document Scanning
A little venting never hurts. The topic is relevant to the implementation
of
an EHR and VistA IMHO. If is difficult enough to integrate this stuff
into a
s
6 PM
> To: hardhats-members@lists.sourceforge.net
> Subject: Re: [Hardhats-members] RE: VistA Imaging FDA and NonCommercial
> Use Re: [Hardhats-members] Re: TIU Interface for Document Scanning
>
> I'd like to add a few thoughts
>
> 1. The FDA document linked above was intere
>
> Funny that you should bring this up as an example.
> Just today I had a patient which had been unhappy
> about the cost of ambien. So I had tried tamazepam.
> But that made him feel hung over the next morning. So
> then we tried triazolam, which is shorter acting.
> Well, today I got a m
Hardhats-members] RE: VistA Imaging FDA and NonCommercial Use
Re: [Hardhats-members] Re: TIU Interface for Document Scanning
I'd like to add a few thoughts
1. The FDA document linked above was interesting. I asks the question
as to what would happen if the system malfunctioned. How
A little venting never hurts. The topic is relevant to the implementation of
an EHR and VistA IMHO. If is difficult enough to integrate this stuff into a
system/culture that is generally technophobic.
I see it everyday, being that I am a drugless practitioner in a medical center
surrounded by
> You know what? Lets have the market decide. We'll
> remove federal,
> state and local government support for ALL
> healthcare, and eliminate
> third party providers, and see just how much someone
> willing to spend
> for Ambien.
Funny that you should bring this up as an example.
Just today I
I agree with Greg here. This is a technical list (hence then name).
It's not that economic or policy issues aren't important or
interesting, this just isn't the right forum.
--- Greg Kreis <[EMAIL PROTECTED]> wrote:
> I don't see how this discussion is relevant to hardhats. There are
> lists wh
I don't see how this discussion is relevant to hardhats. There are
lists where people can debate the cost of medicine and the reasons for
it. We have over 400 subscribers and I suspect that most of them are
here
because this is the hardhats list and they have a general expectations
of the cont
> Ruben, I wonder why you are the only member of this list that uses such
> inflamatory negative words.
Inflammatory is lieing. And there is no need for a careful analysis
here. The muck rating of the Pharmaceutical companies is as evident as
the Grand Canyon. People spend too much time fig
I'd like to add a few thoughts
1. The FDA document linked above was interesting. I asks the question
as to what would happen if the system malfunctioned. How likely is it
that the patient would be harmed, or even killed? Even if document
imaging is not FDA regulated, this is a useful thought?
- Original Message -
From: "Ruben Safir" <[EMAIL PROTECTED]>
To:
Sent: Friday, August 12, 2005 10:44 AM
Subject: [Hardhats-members] RE: VistA Imaging FDA and NonCommercial Use Re:
[Hardhats-members] Re: TIU Interface for Document Scanning
Still,
our FDA approval
> Rhetoric abounds decrying cost of medicine in the U.S. to the point some
> advocate importing from Canada.
It's not rhetorical. It's a measurable and real. There is nothing
rhetorical about the spirally costs of drug therapy and medicine.
> Adding that to the recent fiasco regarding
> th
11, 2005 1:02 PM
> To: hardhats-members@lists.sourceforge.net
> Subject: RE: VistA Imaging FDA and NonCommercial Use Re: [Hardhats-
> members] Re: TIU Interface for Document Scanning
>
> Fair enough. It is just disconcerting to see all this talk about how to
> find "loo
Rusty:Let me inquire to some contacts that might be able to give a
reference. The FDA has supported an AAMI software engineering standard
(SW68-2001) that realtes to the best engineering practices supporting such
closed devices. But I will find out more as this information should be
widely unde
t: Re: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use
Re: [Hardhats-members] Re: TIU Interface for Document Scanning
This thread has covered various theories about the scope of FDA regulation
for viewing images. I have previously posted a *question* asking where
Title 21 describ
This thread has covered various theories about the scope of FDA regulation
for viewing images. I have previously posted a *question* asking where
Title 21 describes regulation of Electronic Medical Records except
within the scope of Part 11 describing their receipt of documents
supporting var
Sure viewing a scanned paper document should not be under the FDA regs. But
if the device is used for clinical interpretation, wouldn't a practicing
clinician want to use a FDA approved device? Camera taking pictures of
things probably doesn't need FDA approval for example in anatomic pathology
o
This was discussed on a long thread in May 2004 at the topica.com site
in which I cited some of the FDA links after struggling to put them in a
context.
http://lists.topica.com/lists/hardhats/read/message.html?mid=910130973
In the use of language about *closed* or *open*, do you mean Title 21
Pa
On 8/11/05, Michael D. Weisner <[EMAIL PROTECTED]> wrote:
> One might then be
> forced to look at the issue of SOUP (Software of Unknown Pedigree) in the
> software device. I wonder if all OS software must be treated as SOUP, since
> there are few if any formal controls on design, let alone V&V.
>
Fair enough. It is just disconcerting to see all this talk about how to
find "loopholes" in FDA regulations (e.g., the use vs. marketing
discussion). I realize not everyone lives in the U.S. and not everyone
is subject to the same laws, but I'd think VistA developers would want
to embrace regulatio
se
> 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 t
ot;Cameron Schlehuber" <[EMAIL PROTECTED]>
To:
Sent: Thursday, August 11, 2005 12:11 PM
Subject: RE: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use Re:
[Hardhats-members] Re: TIU Interface for Document Scanning
>I think "purpose" is being confused with "pri
The FDA has repeated said that the difference of a device from other
non-regulated software is whether its control capability has the inclusion
of an open cognitive loop that precedes the control of a device. In any
particular situation the can be consulted to determine whether this
control cri
From: "Joseph Dal Molin" <[EMAIL PROTECTED]>
> Actually this has nothing to do with open source it is how it is
> distributed ie. sold vs. given away.
>
Actually it appears to have nothing to do with the method of distribution as
explained in http://www.fda.gov/cdrh/ode/guidance/337.pdf
"This
hursday, August 11, 2005 9:45 AM
To: hardhats-members@lists.sourceforge.net
Subject: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use Re:
[Hardhats-members] Re: TIU Interface for Document Scanning
Actually this has nothing to do with open source it is how it is
distributed ie. so
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 freebiethe name escapes me now not sure what the FDA
history of that solution is but it spread far
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
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
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