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 understood by the VistA Community.
On Thu, 11 Aug 2005, Tyrus Maynard wrote:
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
Part 11 ? This part seems to be concerned only with FDA defining under
what circumstances it will accept Electronic records in lieu of paper
records whenever a given party is submitting data to comply with any
regulatory review or approval.
This soothes my belief that FDA is not charged with regulating medical
record systems in medical practices.... even if viewing any image
involves some generic technology (whether it be adjusting ambient light
in a room or adjusting pixels on your monitor). I would like to believe
that generic technology is not a medical device, at least once the given
procedure is completed and archived...and ...I would be disappointed if
medical practice did not leverage generic technology while keeping FDA
busy with other more critical beats.
Here is the link to Title21 Part 11 Do a *Find* on "closed" and "open"
and the discussion is not very enlightening....hardly a mandate for FDA
to scrutinize medical records software as if record keeping and
subsequent access and display of images constitutes a device.
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=ebf33225bf8a91b5c943d06831b245ce&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21
Is there another place where FDA discusses the open/closed paradigm which
you describe as a *cognitive loop*?
Rusty Maynard
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