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mHealth Regulatory Coalition

Latest Headlines

Latest Headlines

MRC pushes for more time on FDA's mobile medical app guidance

In a bit of a surprise move, the mHealth Regulatory Coalition has asked the U.S. Food and Drug Administration to revamp and republish its proposed guidance for mobile medical apps --but as a second

Highest-risk mobile medical apps are focus of FDA's draft guidance

Doctors who are using or recommending mobile apps can breathe a bit easier. The U.S. Food and Drug Administration's new draft guidance , published this morning, excuses a whole raft of lower-level

Classification for mHealth devices could simplify FDA regulation

Developers with the mHealth Regulatory Coalition may have done some important heavy lifting in the struggle to clarify the U.S. Food and Drug Administration's regulation of mobile devices. The

Cloud-based efforts 'front-and-center' in healthcare

Earlier this month, AT&T announced it was partnering with Minnesota-based medical imaging software solutions provider Acuo Technologies in an effort to develop vendor-neutral, cloud-based medical

Industry group questions FDA oversite of m-health devices

The mHealth Regulatory Coalition, an industry group comprised of many of the mobile health IT stakeholders, is weighing in on the issue of when the Food and Drug Administration (FDA) should regulate