"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
