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 have dealt with in the past has addressed this issue in their implementation documents. With some lawyers always putting a spin on things, dealing with a secure EMR is like a PC maker providing protection against SPAM and viruses. You should not have to do that in normal operations if everyone would be civilized. But the real world is not that way. Unfortunately, this applies to scanned paper records also. Truth is most medical practices do not practice safe and secure computing techniques.
----- Original Message ----- From: "Jim Self" <[EMAIL PROTECTED]> To: <[email protected]> Sent: Friday, August 12, 2005 12:06 AM 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 > [email protected] > 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 [email protected] https://lists.sourceforge.net/lists/listinfo/hardhats-members
