5/31/2013

The Office of the National Coordinator for Health IT, the FDA and the Federal Communications Commission have requested public comments about the development of an HIT regulatory framework that aims to ensure patient safety, prevent regulatory duplication and encourage innovation. The framework is expected to help address several HIT issues, such as which mobile health applications should be counted as medical devices and be subject to FDA regulation. The agencies also announced the FDA Safety Innovation Act Workgroup will conduct an online and in-person meeting about the framework this week.

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