Mobile application developers are trying to simplify the trip between home and hospital.
However, these mobile developers might soon discover they’ve bitten off more than they can chew, as the FDA recently sent a letter to one software developer warning them that they needed FDA clearance to market their mobile application.
These are the two main distinctions you should know about the apps out there:
- Wellness- related applications
These applications are geared more towards general health and well-being than any particular disorder. Good examples of these are mobile pedometers, trackers of calories burned, or even sunscreen re-application reminders (more of these than you would think.)
- Disease-related applications
This class of applications are promoted as disease management applications. Examples include grocery store sorters, blood glucose readers for diabetics, Self-Care management apps that help the patient catalogue lab results, and even diagnostic apps that allow physicians to input symptoms and link them together to try to come up with an answer.
Wellness-related applications don’t have to be FDA regulated, but disease-related applications do. The motivation behind the stricter regulations of the disease-related applications is to make sure the devices actually perform their advertised function, as any misrepresentation in this class could harm patients.
In addition to the software itself, any accessory device plugged into the phone or tablet to help a disease-related application operate must also be regulated.
This all also open up some grey area as to where advice ends and disease or medical management truly begins. We suspect that as these applications begin to offer more robust interventions in the lives of patients, the distinctions will become more defined.
Contact ClinEdge if you’re interested in hearing more!