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
