Regulating the App Store

[By Adam Ghosh]

Back when Apple first released the idea of the app store to the public, they probably had no idea how proliferate it would be and how it would weave itself into countless workplaces and individuals’ hands.  A quick look on the store today will return you with some 700,000 apps of which 13,000 are health-related.  With so many apps being released on a weekly basis, the credibility as well as the usefulness of some of these applications began to be called into question (a good example of which is an “x-ray” app which just shows pre-rendered images and responds to movements made by the smartphone).

Enter the FDA

To combat this, the FDA has been working on a set of rules and guidelines that will better weed out the less than ideal applications that could potentially lead to misdiagnosis, as well as a host of other problems associated with individuals receiving information that has not been upheld by a healthcare professional or a credible source.

The problem with these apps comes down to one of categorization.  The FDA has the ability to regulate apps that enter the app store that have tags as “medical software,” but not those that have been submitted under the category of “wellness.”  As you can imagine, apps that have not had their credibility upheld generally don’t get submitted under the first category, but rather the second.  The real problem with this happens when a “wellness” app suggest or recommends healthcare advice that has not been backed up an industry professional and consequently may lead to some serious health problems.

Example:

Let’s take a closer look at a good example of this in action.  A ways back, a large number of software companies were capitalizing on the idea of the pedometer and the ability to track one’s footsteps throughout the day.  It was only a matter of time before the app store saw its versions enter the hands of iPhone users across the globe. The issue?  Some of these apps were just fine, giving users the ability to track their steps and better calculate the amount of calories burned over a given period of time.  However, if the same app has any wording linking the amount of steps you take to weight management or obesity then it moves out of the realm of simply being a wellness application and instead becomes a medical app that has not been thoroughly regulated.

Even though it is a suggestion that has become common knowledge (exercise leading to weight loss) the application has indeed violated the app stores regulatory language.  Often times, the software companies behind these aren’t even aware a violation has occurred until they receive a message detailing the removal of said app from the store. It is this exact problem that the FDA seeks to correct but the changes won’t come overnight.

The process will start with an evaluation of a given app to determine the risk level it poses and if the information given is inaccurate or not fleshed out enough.  Representatives in charge of this movement have stated several times that the process won’t be as all encompassing as once imagined.  The pedometer example is a good indicator of apps that might be passed by when a decision is being made.  While a certain pedometer app may not have a licensed professional substantiating its health claims, the risk an obese person has from exercising is fairly low and thus not a priority of the FDA to regulate said app.

Real Issues

The real issue lies with apps that are more closely tied to high-risk adverse health conditions like cancers, heart problems or acute viruses.  If an app gives you a series of pictures of individuals with a certain kind of rash that is indicative of “X” virus and a user then takes medical advice on the assumption that they share the same symptoms, a serious problem has occurred.

With such a high propensity for misdiagnosing, the FDA isn’t asking that you blatantly ignore or cease to use all applications that have not been backed up by an expert.  The FDA is rather suggesting that individuals use their best judgment when seeking out advice via the app store.  If something appears serious visit a physician or a doctor, not an automated response from an app you paid .99 cents for.

Assessment

The FDA hopes to put the final touches on their regulatory guidelines sometime in the next two months.  When the guidelines go live, you can expect to see a huge change to the quality and quantity of the medical apps that are released onto the iOS store.

About the Author:

Adam Ghosh has over twenty years experience as a researcher in the medical field. In that time he has worked with allergists and vascular surgeons, and everyone in between. Now he supplements his early retirement by contributing to: http://www.weatherbyhealthcare.com

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Filed under: iMBA, Inc., Information Technology | Tagged: Adam Ghosh, Apple Inc, FDA, iOS store, Medical App Debacle, Regulating the App Store | 1 Comment »