up a level  post article  search  admin  Contact  main  parent	Re: FDA Validation a Threat to Free/OSS? by Richard Schilling on Monday April 15, 2002 @ 05:50 PM FDA approved medical devices are generally those devices that are connected to a patient, and used by a health care practitioner to make treatment decisions. Any such devices require a high quality of software that meets certain criteria, and the FDA plays an important role in verifying that quality. The approval process keeps bad software out of pacemakers and CAT scan machines. Getting FDA approval is costly, but if specific Open Source based medical devices get that approval, the credibility of Open Source applications will be strengthened. Processing data that originates from existing FDA approved medical devices with Open Source software is a worthwhile effort and would serve the medical community greatly.	Related Links Articles on LinuxMedNews Also by Richard Schilling Contact author
	The Fine Print: The following comments are owned by whoever posted them. ( Reply ) Re: FDA Validation a Threat to Free/OSS? by I. Valdes on Monday April 15, 2002 @ 09:55 PM It sounds reasonable and the proverbial good thing for software driven devices, but what about EMR's? I think that one day EMR's can and should be validated, but if implemented in the near future, this could kill a lot of Free/OSS EMR's. -- IV [ Reply to this ] Re: FDA Validation a Threat to Free/OSS? by Jim Kandler on Monday May 10, 2004 @ 10:49 AM I don't understand why this would "kill a lot of Free/OSS EMR's". I hope you are not implying that the practices used to develope them are second rate. If the code is worth writing it is worth validating. The EMR is very important and if not working properly can kill or mame someone. We have all heard of the patent who was mistaken for another and had the wrong surgery. A similar thing can happen if my records get into your file. [ Reply to this ]   The Fine Print: The following comments are owned by whoever posted them. ( Reply )

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