With 2012 rapidly coming to a close, an article published recently on the mHIMSS website by attorneys at Arent Fox law firm in Washington, D.C. reviewed some of the regulatory issues that made mHealth news this past year that they believe also will spill over into 2013.
At the top of the lawyers' list was the U.S. Food and Drug Administration's ongoing efforts to finalize guidance for the industry on mobile medical applications; the guidance is intended to establish a pathway for regulating certain MMAs as medical devices. The FDA issued a Draft Guidance for Industry on MMAs in July 2011, and the industry submitted a large number of comments to the agency in response.
The FDA expects the MMA grouping to be a "small subset" of the wider health app market, and is focusing "only [on] those mobile medical apps that present the greatest risk to patients when they don't work as intended," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in July. The agency is expected to continue working with industry in 2013 to issue a balanced Final Guidance to Industry on the regulation of MMAs.
The lawyers also expect Meaningful Use to have more of an impact on the mHealth industry, going forward. The final rules for Stage 2 were published in September by the Centers for Medicare and Medicaid Services, and included stipulations requiring providers to engage their patients via electronic methods; mobile devices could very well help to facilitate such engagement.
To learn more:
- read the article