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FDA decision frees health IT developers
Federal Times: In the tightly regulated world of healthcare delivery, those who toil in the fields of information technology had been facing a quandary. Is health IT medicine? If so, it would be subject to government regulation. If it is technology, however, it would be exempt from the rigors of oversight.
The Food and Drug Administration resolved the question with the April publication of a framework declaring that the products of health IT are not the same as medical devices and thus not subject to healthcare regulations. Now companies are sorting through what the decision means for their products and systems.
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