thanx Rick...there is an app to monitor your skin for cancerous spots (sounds useful, I was wondering whether to use it), would that be example of FDA regulated app as it requires some decent accuracy in diagnosis?...one could argue that if the software alerts you would go to dermatogolist anyways so there is no really a downside...Kris
It does seem that the US government likes to stand in the way of progress. If medical manufacturers go to Europe or Asia because they can get their devices approved quicker, than the FDA needs to change. It sounds like they want to, but I would be surprised if they really do.
Anyone have any experience with the new wrist bands that monitor your activity? It seems like a good way to help improve your activity and sleep cycles with feedback. I hope the FDA will not decide to regulate these.
The use of mobile computing devices holds much promise for improving disease treatment and quality of medical care. It would be a shame to watch the cost of these devices exponentially rise because of demands of overbearing regulation.
If all those medical apps are forced to have a statutory message saying
" The results provided by this App are indicative only. Please consult your doctor for the final diagnosis of the symptoms"
then majority of the concerns of a potential risk to the patients can be addressed. The patient using the app is always advised to visit a doctor to take the second opinion when the situation warrants.
And this regulation can be effected more quickly than the time consuming certification of the Apps.
I suppose it is an advantage to know that any and all apps in medical use have gone through a proper process in order to determine whether they're appropriate for use in that way. But it's likely, as part of a trade-off, that American vendors and manufacturers will continue to complain as long as the US government gets in their way with painstaking regulations.