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Are HIT Tools Medical Devices?

Posted July 02, 2010 7:52 AM

The Food and Drug Administration is reconsidering its previous decision to exclude health information technology (HIT) tools from regulation as medical devices. A decade ago HIT comprised rudimentary clinical documentation systems and administrative applications but these tools have now become part of the clinical workflow itself. Is regulation of HIT tools as medical devices premature? Should the same standards used for medical devices be applied to HIT tools?

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Guru

Join Date: May 2010
Location: Metro.Manila, Philippines.
Posts: 1269
Good Answers: 27
#1

Re: Are HIT Tools Medical Devices?

08/04/2010 10:32 AM

Anything and everything used in connection to the delivery of care to patients should be considered and labeled as medical devices. When the usage of such can and may affect the quality of healthcare delivery, it should be governed by all applicable medical device standards. The bigger concern and issue at hand is, who will be that governing body will be? FDA as it was named and created is supposedly that body, BUT the present role, composition, visions, etc., are and be considered as a Big joke for the general public. The agency is self-serving catering more to big lobbying organizations, pharmaceutical, medical equipment manufacturers as well as influencial medical associations. Even medical research and developments are being curtailed, mostly limited to what can be conceived as profitable business-wise in the future. And for those same reasons why consumer's are being neglected, as test subjects or research guinea pigs where public interests are at the bottom of their priorities.

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