The FDAs recent release of its guidance on mobile medical applications met generally widespread support among those in industry and medical practice alike. With the clarification of regulatory guidelines, industry experts predicted a surge of new mobile applications and physicians welcomed better understanding of the role of their existing mobile devices.
While the grey area of uncertainty surrounding the necessity of FDA clearance has been reduced and physicians and patients can breathe a sigh of relief knowing that there may be federal validation for new and existing mobile healthcare tools, the document will have some rarely discussed consequences. While the mobile healthcare app market free-for-all was in absolute need of regulatory and future guidance, its important to note the winners and losers in the departure from a completely open playing field.
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