Andrew, > As far as I know, medical record systems are not medical devices!! Is this > contrary to anyone's understanding? It is contrary to my understanding of the respective German law.
I understand that there is a fine line whether or not it applies. Let me give an example: As long as the system uses its drug database solely for letting doctors select drugs for a prescription without giving any further information about them (like a specialized word list) it wouldn't be considered a medical device. However, as soon as the system starts supporting the medical decision making process (be that by suggesting equivalent drugs of lower price, be it by cross checking patient allergies/gravidity/drugs, be it by offering advice on dosage based on age/weight etc.) it would then be considered a medical device. It can be argued, of course, whether the medical _record_ system in toto needs to meet the FDA specs or rather just the medically-augmented prescription application. Karsten -- GPG key ID E4071346 @ wwwkeys.pgp.net E167 67FD A291 2BEA 73BD 4537 78B9 A9F9 E407 1346
