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Challenges Abound In Creating Regulatory Framework For Mobile Medical Apps, Health IT

FDA plans to release guidance for mobile medical apps ahead of a larger regulatory framework on health information technology, according to an agency official.

FDA still aims to finalize a draft guidance on mobile medical applications by the end of the year, CDRH policy advisor Bakul Patel told “The Gray Sheet” recently. But guidance on related medical software, including clinical decision support tools, electronic medical records and health information technology, is proving more complex and will likely take longer, he suggested.

Patel and other agency officials spoke Sept. 20 at an FDA user fee update meeting hosted in Washington, D.C., by...

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