Healthcare IT Terms
What is FDA mHealth Regulations?
FDA mHealth regulations refer to the Food & Drug Administration’s (FDA) regulations on mobile health applications and software that generally collect, share and ensure access to health information. The FDA mHealth regulations fall on the following:
- A mobile health application which functions in a similar way to that of an FDA-regulated device,
- Health applications that are accessories to the regulated device
- Mobile health applications that help with diagnosis and treatment suggestions