Healthcare apps: Time for a second opinion?

It’s one thing to trust an app that counts your steps throughout the day. It’s another thing to trust an app that helps to diagnose you with a serious illness. As the number of healthcare apps continues to grow, the questions remains: Can healthcare apps be trusted?

This is becoming a key question lately for consumers, healthcare professionals, app developers and the media – and it’s one that we wanted to briefly address in today’s post.

There’s a sound reason why the general public places their trust in prescription drugs and medical devices – namely, regulation. But while the United States Food and Drug Administration (FDA) regulates most medical devices, they review very few applications. At this point in time, experts say that the FDA’s power and efforts aren’t nearly enough to cover the estimated 97,000 health apps currently in the app stores – a number that will only continue to grow in all likelihood.

While these apps hold great promise, they offer have the potential for to cause great harm, as recently noted:

Without a new approach [to regulation], consumers risk aggravated conditions or even death due to poorly designed, fraudulent, or dangerous technologies, these critics say. Healthcare providers, too, find it increasingly difficult to discern valid from invalid apps, making it tougher to recommend mHealth apps to motivated patients.

In a recent editorial published in The New England Journal of Medicine, health law expert Nathan Cortez and his colleagues also questioned the validity of the promises made by many of these apps to improve health and reduce medical error. While a large number of health apps are out there simply to help consumers track their exercise or dieting habits, there are plenty of other apps that pose a more concerning risk to their faithful users. Apps that handle issues like managing insulin doses for diabetic patients, for example, could simultaneously affect an entire userbase if a single mistake or bug enters into the app’s infrastructure, assuming the app could be deemed safe and trustworthy from the start.

According to Cortez, “Early studies evaluating whether these apps work or not tend to paint a pretty dim picture of them. The results aren’t that promising.”

Over the past decade, the FDA has approved about a hundred medical apps. According to the agency, roughly 40% of these approvals came in the past two years. For the most part, these apps are just mobile adaptations of (or accessories to) traditional, regulated medical devices.

In September 2013, the FDA presented their official stance for what types of products and technologies would fall under their jurisdiction. In regards to the mobile health industry, the agency conducts a pre-market review for apps when the app developer submits information to the FDA seeking out their approval. Only sometimes has the FDA taken enforcement actions by issuing a public reprimand to a company whose products violate their rules and regulations.

The issue at hand is that the FDA’s jurisdiction is limited to only those that constitute a medical app, as opposed to a rudimentary health and fitness app. This is a fine line that mobile app testers and developers may need to walk if they feel they could be in danger of FDA persecution.

“It looks like Congress is building momentum towards some kind of legislation, some type of bill actually passing,” states Cortez. Thus far, there have been several laws proposed in Congress in an effort to change the FDA’s regulatory approaches in this matter, but none have passed. The case against expanding the FDA’s oversight is that too much tech regulation can serve to stifle innovation in the mobile health industry – an industry that certainly can provide an incredibly helpful resource to the general public.

It will be interesting to watch the progress of healthcare apps over the next few years. While the FDA may not require approval in every instance, consumers will most certainly demand apps that are high in quality.

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