In issuing the report, the FDA took a very balanced view and did not expand its regulatory scope. It defines the world of medical devices and applications as
1. Administrative - i.e. something that reminds you about an appointment
2. Wellness - i.e. something that reminds you to exercise, stay hydrated, and eat right
3. Medical Device - i.e. something that measures a body signal and initiates a specific diagnosis or treatment.
#1 is not subject to regulation. #2 will have oversight by ONC but no regulation. #3 will be regulated by the FDA.
The FDA makes clear it will not focus on #2 and it will not regulate cell phones/smart phones because a mobile medical application can be operated on one. Devices that perform wellness management will not require registration or product listing.
Given the responsibilities assigned to ONC, it’s likely ONC will have to add staff with device and mHealth expertise. The language in the report suggests that ONC’s standards and best practices for wellness applications will be voluntary.
It’s always a challenge to balance innovation and government regulation. The idea of harm reduction through a risk-based framework makes great sense.
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