FDA health app regulation won't cost $30M

By Brian Dolan
04:14 am

Brian Dolan, Editor, MobiHealthNewsIn recent months it's become clear that the media is increasingly turning its attention to mobile health.

The attention, of course, is welcomed by most everyone working in mHealth today, but sometimes it's painful to read the hyperbole, exaggerations, and misconceptions that are perhaps inevitable with the increase in coverage.

Proteus Biomedical is one company that has noticed this hyperbole. The media often uses words like "Orwellian" and "Big Brother" to describe the company's medication adherence technology. A recent report over at Dark Daily piqued my interest by stating that Novartis had an exclusive deal with Proteus for all of its drug delivery technology, because we had reported the exclusivity was only for certain use cases, including organ transplant drugs. A rep from one of the companies confirmed the report's inaccuracy. After all, if it were true it would be tantamount to Novartis acquiring the company, right?

A number of readers called my attention to a Bloomberg report published last week. One reader called the report "totally and completely absurd" among other things.

Bloomberg wrote that the US Food & Drug Administration may regulate the chips in mobile phones along with health apps. They also wrote that FDA clearance of apps and devices could cost device makers more than $30 million a pop. They also quoted someone as stating that the Apple AppStore offered between 20,000 and 30,000 "wellness apps."

Let's take these one at a time.

Sure, the FDA has yet to add guidance for ongoing regulation of mobile health apps and devices. It has been suggested that in some cases the FDA could consider smartphones as accessories to medical devices and deserve some regulatory attention. I have yet to hear someone claim that the individual components of smartphones would be subjected to the same review.

What about the costs of such regulation? While some medical devices can cost tens of millions of dollars or even hundreds of millions of dollars, the recent experience of at least two mobile health companies says otherwise. One medical app company and another mobile health device company that secured FDA 510(k) clearance told me that the process cost under $1 million -- in the hundreds of thousands of dollars range. Sure, the 510(k) process technically means that the Bloomberg article's headline is correct and "Apple’s IPhone Health Tool May Get Same FDA Scrutiny as Stents," but that doesn't mean it will cost anywhere near as much.

Finally, the article claims that the "online Apple store features 20,000 to 30,000 wellness apps." That's one metric we have tracked closely over the years and 20,000 apps, let alone 30,000, is way off the mark. Assuming "wellness" apps are ones intended for use by consumers (could an EMR app for physicians really be a "wellness" app?), our last apps report found that the AppStore offered just under 5,000 health-related apps intended for use by consumers. That was last September. Today, the total number of apps found in the Health/Fitness and Medical categories of the AppStore is still less than 15,000. That number includes those for healthcare professionals, which are usually about 30 percent of the apps, and the miscategorized, which typically hover around 20 percent.

You can watch a Bloomberg video report based on a distillation of the article discussed above over at YouTube. Each of the metrics are discussed in the video. Of course, the video's introduction is: "I hope you never have to do this, but [if] you need to diagnose a heart attack, well, there is an app for that."

It's all downhill from there.

As the discussion heats up around mobile health and the industry enjoys the benefits and pitfalls of sitting atop the Gartner Hype Cycle, let's do what we can to help the discussion avoid becoming "totally and completely absurd." Bloomberg, of course, is not alone in the hyperbole but this report was particularly emblematic of the dangers of hype in mHealth. Thanks to those readers who sent it in.


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