I have been working with IRISSMedical on and off for the last two years implementing their Android-based Eye Check. The solution is currently going through ISO 62304 and compliance testing so it can gain regulatory approval. The work required to get it there has been non-trivial. Regulatory approval is required before it can be relied on by medical practitioners.
As I see it, and evidenced by the Research2Guidance report, there are two types of mHealth app. The first are ‘health productivity’ or ‘reference’ apps for fitness and wellness. The second type is more serious, used by health practitioners or patients themselves, the incorrect use of which could harm people/patients. Apps in the second category need to be known to work and be accurate.
Most apps are currently in the first category. While these apps are very useful, the more life changing, enduring (and profitable?) apps are those in the second category. Unfortunately, we have lots in the first category and not many of the second type. It’s apps in the second category that are needed in the future to help resolve increasing health spending deficits and allow self diagnosis and treatment in the home.
Some of the comments in the report are telling…
"Lack of … a clear regulatory framework … are perceived as neither major barriers nor major mHealth market drivers"
"mHealth app publishers are also somehow indifferent to the existence of a regulatory framework."
"App publishers do not have a clear view on whether or not the mHealth guidelines published by the (US) FDA last year constitute a comprehensive framework for the mHealth industry."
My view is that we don’t have enough of the right kinds of apps to determine the real issues, one of which I believe is regulation.
One respondent did say…
“If you want FDA approval for your app, how can you achieve this with Android OS upgrades at least 3 times a year? How can you be FDA compliant with the latest platforms? FDA is so slow and not suitable for mobile apps!”