Infographic: FDA's multi-layer regulatory structure for mobile medical apps
Despite the security and privacy risks that mobile apps pose for medical use, the Food and Drug Administration is "leading the way in defining a regulatory path for mobile medical apps (MMAs)", explains an infographic from high-tech product design and development consultancy Sagentia.
The FDA breaks down MMAs into regulated, unregulated and enforcement discretion categories. An example of an unregulated MMA would be a heart rate monitor on a wrist band used for health and fitness; enforcement discretion MMA would be a smartphone app used for patient coaching.
Under the regulated category, the FDA distinguishes between lower risk (e.g., a remote laboratory monitoring system), medium risk (e.g., an implantable glucose sensor that transfers patient data) and higher risk (e.g., point-of-care diagnostic tool using a smartphone camera and app to collect and interpret patient data).
"The FDA has a good framework in place for evaluating whether an app will be regulated or not. Risk analysis is key," Sagentia explains.
To view the full-size infographic, click here.