Dive Brief:

• HHS, the FDA and the FCC have released a joint report outlining how healthcare IT (particularly mHealth) will be regulated. The report, which is now headed for Congress,  was required under the Food and Drug Administration Safety Innovation Act.
•  In the report, the FDA said it will not actively oversee what the report calls 'Administrative HIT' even if the products meet the FDA's definition of a medical device.   "We believe a limited, narrowly tailored approach… is prudent," the report said "We also recommend that no new or additional areas of FDA oversight are needed."

Dive Insight:

Health IT vendors must be pretty happy with this report. For years they've been worried that their products would be regulated as medical devices.  Now, while they are facing a fair amount of guidance and regulation from the ONC, that's a much better proposition than having the FDA get involved in regulating a market which isn't its strong suit.  This is particularly good news for mHealth ventures, as a heavy-handed FDA approach might undermine explosively growing sector. Under ONC's guidance, however, I believe health IT will find a stern but evenhanded approach to guiding the health IT.