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-- Forwarded message --
Date: Wed, 31 Aug 2005 09:53:53 -0400
From: "Callaghan, Jim" <[EMAIL PROTECTED]>
To: 'A. Forrey' <[EMAIL PROTECTED]>
Subject: RE: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Us
Sorry Thurman, but I would like to contribute one last gasp on this thread.
And Rubin, I thought you were doing better at trying to avoid that stroke,
but I fear you are falling off the wagon! As I recall, you are a pharmacist,
so it is understandable that you are knowledgeable and passionat
Perhaps a little venting never hurts, but I do not think Ruben's rant
qualifies as "a little venting". Such inflamatory words can and do hurt.
- Original Message -
From: "Mark Street" <[EMAIL PROTECTED]>
To:
Sent: Friday, August 12, 2005 3:07 PM
Sub
Yes, pleae. It is only natural to expect that many of the members of
this list are here because they are concerned about the cost of
healthcare and want to do what they can to make healthcare more
accessible. We DO need to be tolerant of one another's views and
sometimes be willing to accept disagr
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 process has far mor
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
Medical images do have an additional area of security with which other
applications may not be concerned. One has to evaluate the risk if one does
not ensure somehow that an image is never modified or replaced. Again this
gets back to the legal aspect of the medical record. Every PACS vendor I
h
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
f Of Nancy
Anthracite
Sent: Friday, August 12, 2005 12:32 AM
To: hardhats-members@lists.sourceforge.net
Subject: Re: [Hardhats-members] RE: VistA Imaging FDA...
The FDA was mentioned in my initial post because the routines we could use
that connect the TIU and the image have FDA notices on them, and I did
The FDA was mentioned in my initial post because the routines we could use
that connect the TIU and the image have FDA notices on them, and I did not
want to run afoul of the FDA if parts of the code were used, hence the reason
I called them again.
On Friday 12 August 2005 12:20 am, Roy Gabe
Exactly, diagnostic imaging (interpreting a chest x-ray or an MRI) is
regulated by the FDA, clinical imaging (viewing an image of an EKG or even
looking at the same chest x-ray as the Radiologist but not for diagnostic
reasons) is not regulated by the FDA. Software used for diagnostic purposes
is
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.
>
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
I think "purpose" is being confused with "price". Whether something that is
FDA regulated is paid for, free or even given to someone to use along with a
cash incentive, it's the PURPOSE TO WHICH IT IS PUT OR LLKELY TO BE PUT that
is going to determine whether the item is regulated or not. Of cour
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