A sub-workgroup of the FDA Safety Innovation Act met July 19 to come up with recommendations about whether and how mobile health applications and health IT should be regulated. The group decided that mHealth and HIT should not be subject to FDA oversight with some exceptions, including medical device data systems, medical device accessories that are used with smartphones and some clinical decision support apps or software. The full FDSIA workgroup will consider the recommendations before sending them to the ONC and the FDA.

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