Medical apps may not be strangers to doctors’ offices anymore but they also realize that apps are difficult to recommend responsibly to patients or even to find, because there is no real guidance or validation. This current article in JAMA online confirms the perception and the need for care integration that both Editors Charles especially and Donna have pointed out lo these many years. However this Editor is quite disillusioned at the attempts to date to ‘curate’ apps with the Happtique failure and the relatively low profile to date of IMS Health’s AppScript and professional review site iMedical Apps and the stated intentions of SocialWellth which purchased Happtique. The reality is that the numbers are against it–IMS Health in their study estimated 40,000 medical apps–in 2013. For apps that want to take the high road, it’s economically difficult, but could be rewarding in the long term. The WellDoc BlueStar diabetes tracking and management support app did with FDA clearance and prescription-only use, but few so far can see a revenue model there. Also MedCityNews.
Intended use determines degree of health app regulation–and also how you communicate your attributes and performance claims. Bradley Merrill Thompson, who performs an invaluable service by advising our field on regulation, compliance and interacting with FDA, demonstrates how a developer can determine where the intended use of an app might fall on the regulatory spectrum. In the second half of the article, he gives descriptions of how a fictional app’s features and claims can move an app from unregulated to FDA Class I and II, increasing the amount of scrutiny and regulation that may not be warranted based on the intended use and the market. This last is especially valuable for those of us in marketing and sales–and also designers, engineers and CEOs. What we call ‘saying it safely’ often falls on deaf ears. As the Wild West begins to acquire churches and farms–there’s no more getting away with ‘fast ones.’ FDA medical app regulation and the art of intended use (Mobihealthnews)