Say there was one, FDA....etc. approved version of Linux....perhaps the NSA version would be a good place to start...would that not encourage the use of Linux? What might at first seem like an onerous hurdle could in fact be a blessing if there were a way to fund such an effort.
I too will stick to my glasses.... Joseph ------- Joseph Dal Molin e-cology corporation www.e-cology.ca 1.416.232.1206 ----- Original Message ----- From: "Tim Churches" <[EMAIL PROTECTED]> To: <[EMAIL PROTECTED]> Sent: Wednesday, January 30, 2002 6:03 PM Subject: Re: FDA endorses open source > "John S. Gage" wrote: > > > > There, I knew that would get your attention. > > > > I spoke today at some length with John F Murray at the FDA who is the > > lead author of the new Guidance. He said quite explicitly that the > > FDA regulations do not apply to standard patient record keeping > > systems. He referred me to HIPAA for guidance about that. > > That's an interesting dichotomy. Here in Oz, our equivalent of the FDA > is the Therapetic Goods Administration (TGA), and they too are only > interested in goods/products/devices which directly prod, slice, zap, > get implanted into, biochemically alter or otherwise have some effect on > living humans. This interest undoubtedly extends to the software which > may command and control such things. However, like the FDA, the TGA has > never (AFAIK) expressed any interest in software which stores and > manipulates medical records which then cause doctors, nurses and other > health professionals to prod, slice, zap, implant things into, > biochemically alter (through presribing and administration of drugs) and > otherwise have some effect on living humans. I suspect that the > rationale for this lack of interest in medical record systems is because > the human health professionals which are interposed between the > electronic medical record and the patient provide checks and balances. > This may or may not be the case. I know that in my youndger days as an > intern and resident, I could only be described as an automaton towards > the end of a 36 hour shift... Indeed, if electronic medical record > systems are to succeed, then they must be trustworthy - what is the > point if you always have to check that the medical record is presenting > the correct information? With pen-and-paper records, I may not trust or > believe what a colleague has recorded, but at least I can be fairly > certain that the barely legible scrawl on the page is as s/he recorded > it. > > So formal validation is, IMHO, a Good Thing in Principle. The only > question is how to go about it in a way which is equitable (that is, > doesn't penalise open source projects with zero capitalisation) while > still being adequately thorough. I suspect it will mean bringing a lot > more discipline and rigour to the way open source "testers" approach > their task. Tricky. > > > Apparently > > Mr. Murray was at a meeting with manufacturers of laser eye surgery > > devices and asked what the device did when Windows crashed. They > > hadn't thought of that. > > I think I'll delay my radial keratoplasty (or whatever the procedure > which fixes myopia is called) until a Linux version of the machine is > available... > > Tim C > >
