Data Connectivity

A weakness of the EndoGoddess App (and others like it) is the fact that glucose journal entries must be typed into the data fields by the user rather than automatically filled in by the glucometer which actually stores all of the glucose readings. Currently, the FDA requires a separate regulation process for apps that connect to medical devices (full policy here). However, when an app requires a user to enter data themselves and does not instruct any management advice or algorithms, the app does not require FDA regulation for release.

Glucometers are without question medical devices that should have FDA regulation as they are devices upon which people with diabetes owe their glucose control and lives to everyday. Every aspect of the glucometer development and quality process as well as functioning is carefully assessed by the FDA.

However, transfer of data (or connectivity) with the meter to an app does not carry the same weight in my opinion. Glucometer technology transfers have minimal to no errors as has been shown by many device companies in their FDA approval process. Perhaps device makers that have their data stored in the cloud (rather than the device) can assure the FDA that their data precision methods and software are consistent as part of the FDA device approval. This would allow a free marketplace for app developers to use the quality-assured, FDA-regulated data without redundant work by the app developers who seek only to display this data. I am researching this possibility for the EndoGoddess App given the importance of connectivity in taking the EndoGoddess App to the next level.