Dive Brief:
- HHS, the FDA and the FCC have released a joint report outlining how health care 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 probably facing a fair amount of guidance and regulation from the ONC, that's a much better proposition than to have the FDA get involved in regulating a market that isn't its strong suit. This is particularly good news for mHealth ventures, as a heavy-handed FDA approach might undermine an explosively growing sector. ONC, however, is likely to take a stern but evenhanded approach to guiding the sector.