When federal agencies hold a three-day public meeting next month to get feedback from stakeholders on their health IT report, one technology area that will no doubt garner prominent discussion is mobile medical applications. Though the draft report developed by the Food and Drug Administration, in consultation with the Office of the National Coordinator for HIT and the Federal Communications Commission, contains a proposed strategy and recommendations for a risk-based regulatory framework for health IT, it says very little about mobile technology.
Section 618(a) of FDASIA explicitly directed that the agencies publish a report to Congress that includes mobile medical apps. However, the document simply summarizes in a single paragraph the essence of the FDA's 43-page September 2013 final guidance on mobile medical apps, reiterating the regulatory agency's "narrowly focused approach" to oversight of these products and its intention to concentrate on a "small subset" of the app market--only those apps that present the greatest risk to patients if they do not work as intended.
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