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FederalTimes : FDA decision frees health IT developers

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. “The new FDA framework on health IT goes further than previous documents from the FDA and will lead to less confusion and aversion of healthcare for developers,” said Travis Good, CEO of health software company Catalyze. The FDA declaration goes even further, noting that even IT products that straddle the line still will be exempt. “For most health IT products that may be considered devices, FDA does not intend to focus its oversight on them,” said Bakul Patel, senior policy advisor for the FDA’s Center for Devices and Radiological Health. Read more :|head

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