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 Gaber wrote: > 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 regulated by the FDA, it becomes a medical device. Software > used to view images for non-diagnostic purposes is not a medical device, it > is an image viewer like the Gimp or Microsoft Paint. > > I was under the impression that this discussion started out by determining > the best practice approach to scanning in paper records into a digital > environment, the FDA does not even enter the conversation in this scenario. > > > > -----Original Message----- > From: [EMAIL PROTECTED] > [mailto:[EMAIL PROTECTED] On Behalf Of Jim Self > Sent: Friday, August 12, 2005 12:06 AM > To: hardhats-members@lists.sourceforge.net > Subject: [Hardhats-members] RE: VistA Imaging FDA... > > Gregory Woodhouse <[EMAIL PROTECTED]> wrote: > >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). > > Gregory, I think you misinterpret. Past discussion was not centered on > findling loopholes > but on finding a reasonable interpretation of FDA guidlines. As best I can > understand so > far, both free software and medical records systems are outside of their > jurisdiction. > > >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 regulations designed to promote quality and safety, not > >attempt to skirt them. > > Intentions and effects are not the same. You must be aware of the old > aphorism "The road > to hell is paved with good intentions". Regulations intended to promote one > thing may in > fact do something entirely different or with side effects that outweigh the > benefits, just > like computer programs may give unexpected results, especially in their > earliest > iterations and when applied to new situations not anticipated by their > designers one or > two decades earlier. > > >As far as scanned documents go: well, I think I've already said I think > >trying to use medical imaging software and equipment to manage scanned > >documents is a ridiculous case of overkill. But I'll just leave it at > >that. > > Perhaps a distinction should be made between diagnostic imaging and > clinical imaging? If > there is any case to be made for FDA regulation in this area, it would seem > to be clearest > for diagnostic imaging. > > As I see it there is nothing special about clinical imaging to distinguish > it from general > non-medical imaging other than 1) the requirement for a reliable connection > between image > files and data elements in a medical records database and 2) access > controls on the image > files consistent with the access policy that applies to the data. There is > nothing > specifically medical about these data integrity and security issues except > for the content > and structure of the database and the roles of the people who use it. > > >--- Thurman Pedigo <[EMAIL PROTECTED]> wrote: > >> 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 > > > >=== > >Gregory Woodhouse <[EMAIL PROTECTED]> > > --------------------------------------- > Jim Self > Systems Architect, Lead Developer > VMTH Computer Services, UC Davis > (http://www.vmth.ucdavis.edu/us/jaself) > > > ------------------------------------------------------- > SF.Net email is Sponsored by the Better Software Conference & EXPO > September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices > Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA > Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf > _______________________________________________ > Hardhats-members mailing list > Hardhats-members@lists.sourceforge.net > https://lists.sourceforge.net/lists/listinfo/hardhats-members > > > > ------------------------------------------------------- > SF.Net email is Sponsored by the Better Software Conference & EXPO > September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices > Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA > Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf > _______________________________________________ > Hardhats-members mailing list > Hardhats-members@lists.sourceforge.net > https://lists.sourceforge.net/lists/listinfo/hardhats-members
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