Interesting thread. Thanks to Brian for getting it started. Thanks also to Brian for coming to the last CORBAmed session and providing some education on Open Source. As CORBAmed works to get the next version of the Healthcare Roadmap, for Component Technologies drafted, it has come increasingly clear that the user community has great potential power and influence in this area; defining the requirements for the functionality a piece of software is expected to perform at. After discussions with several vendors at the CORBAmed session, the issues of costs to develop, test and conform to accreditation criteria became increasingly overwhelming. Seemed like a no win situation. The users lose, the vendors lose...not a good thing. After reading this thread, a thought occured to me. Vendors provide software to a variety of customers, and we all know that specialized "tweaks" must be made for each customer. What if there was a forum where you could submit software and validated software resulted on the other side? A software accreditation of sorts. Who would pay for such a thing? Would users see the long term cost savings and justify supporting such a notion. Of course a similar notion exists with the Open Group "branding" program. An validation of software is expensive due to all the issues raised on this thread. However, if there was a healthcare accreditation for software compliance would the industry take one giant step forward through cooperation? Would it result in an overall cost savings to both the vendor and user community? Is the user community strong enough to organize such a long term strategy, to effect such changes? Another paradigm is the shift of the business case for vendors from one of product to one of service. This will take some evolution, however, I believe we have already seen this in other industries. Take the cell phone for example. Remember when it used to cost hundreds of dollars for the phone and then you had to pay for air time? Now the phones are free and you pay for the service. Could a similar paradigm be on the horizon for healthcare software applications? OK, a lot of loaded words and baiting questions. Just some thoughts. Let the discussions continue. My $0.02, -Mary Mary E. Kratz, MT(ASCP) University of Michigan Health System Medical Center Information Technology 4251 Plymouth, Suite 3000 Ann Arbor, MI 48105-2785 v: (734) 763-6871 f: (734) 998-6806 >>> Arun Sivashankaran <[EMAIL PROTECTED]> 09/10/99 09:11AM >>> I am fairly new to the group, but coming from the commercial medical (not open-source) software development environment, I see this as the main concern. The only way that i can see an open source medical project getting FDA 510(K) and the like is if one lead person or group assumes responsibility for the VAST amounts of paperwork that have to go into it before, during and after the project. This does not even begin to address issues such as clinical testing, etc. How are these issues addressed in the current projects? Someone has to assume responsibility for ultimate compliance. Perhaps the current FDA model isn't ammenable to open-source projects. I would appreciate some feedback, as I think that there could be a very viable role for open-source in the medical community. Thanks, Arun Sivashankaran Project Engineer BIOMEC, Inc. On Thu, 9 Sep 1999 [EMAIL PROTECTED] wrote: > > > One topic to be pursued within such a forum is open source standardization > and certification, e.g., for FDA or eventual HIPAA compliance. The nature > of gov't regulations for FDA requires rather strict record-keeping which > seems to be problematic for the open source development paradigm. > Similarly, for security compliance -- which may well include record-keeping > to ensure secure development practices -- how can open source contributors > deal with that? > > Comments? > > > > >
