HEALTH NEWS

Who Regulates All These Health-Related Apps?

Written by Shawn Radcliffe on September 14, 2017

Tens of thousands of apps are trying to help you live healthier and longer, but only a few are regulated by the government to make sure they work.

app regulation

Want to improve your memory?

Track your sperm count from the comfort of your own home?

Take your temperature from your armpit?

There’s an app for all those.

And now researchers from the University of Washington are working on an app that screens for pancreatic cancer using a smartphone’s camera and special algorithms.

But will it work?

To answer that question, researchers have already subjected the app to a small clinical study — with the app correctly identifying almost 90 percent of potential cases of pancreatic cancer.

And that’s just the beginning of the testing process before this is deemed app-store ready.

It sounds impressive — mainly because it is — but not every health app undergoes this kind of rigorous scientific testing.

So who’s minding the app stores to make sure that these software products that promise to diagnose your health problem, track your vitals, or improve your overall wellness actually work?

Limited FDA oversight

If you answered the Food & Drug Administration (FDA), then you’re right — but just barely.

Of the more than 156,000 health and wellness apps, the FDA regulates only about 200.

These apps are ones that effectively function as a medical device or are connected to one — such as an app that analyzes your urine from a photo of a soaked chemical strip, or a device that allows health professionals in rural or remote locations to do vaginal or cervical exams and send the results to a doctor at a hospital.

Given the FDA’s limited resources, the agency focuses on regulating apps that could potentially kill or harm you. These apps require formal FDA approval — including clinical trials.

There’s another group of apps that the FDA could regulate but doesn’t — as long as companies don’t market their app as diagnosing, preventing, or treating health conditions.

This loophole is similar to the disclaimer used by nutritional supplement companies to avoid FDA scrutiny.

This includes apps that track your fitness, remind you to take your medications, or identify possible medical conditions based on your symptoms.

The last group consists of everything else — such as health or medical reference apps. The FDA leaves these alone.

“There’s the whole bottom of the pyramid — all these wellness apps. It wouldn’t be practical for the FDA to regulate them. But consumers probably need help choosing the right ones and the best ones to use.” Dr. Aaron Neinstein, director of clinical informatics at the University of California San Francisco (UCSF) Center for Digital Health Innovation, told Healthline.

False app advertising

When it comes to monitoring health apps, the FDA is not the only regulatory game in town.

The New York Attorney General’s office has already called a few developers on the carpet for overstating their app’s capabilities and having irresponsible privacy practices.

Earlier this year the office settled with three companies over health apps sold in the Apple iTunes or Google Play stores — Runtastic by an Adidas subsidiary, MIT Media Lab’s spinoff Cardiio, and My Baby’s Beat by Matis.

All three apps claimed to measure your — or your unborn baby’s — heartbeat accurately using a smartphone’s camera and sensors. But without any science or testing to back up their claims.

According to the terms of the settlement, the developers agreed to pay $30,000 in combined penalties. They also agreed to change their marketing to make it clear that the apps are not medical devices and not approved by the FDA.

The Federal Trade Commission (FTC) has also gone after a few companies for exaggerating their app’s capabilities.

While the FDA is proactive about regulating apps that fall within its scope, the FTC is reactive. This allows many companies to make unfounded claims about their apps for a long time before getting caught.

Among them is “brain training” company Lumosity, which last year settled with the FTC to the tune of $2 million.

Wild West of app stores

You might think the app stores, with their rating systems and reviews, would make it easy to choose health apps that work.

There’s a big difference, though, between choosing an app to play while waiting for your train and finding one that improves your memory or monitors your high blood pressure.

“The app stores weren’t in any way designed for the challenges of health-related claims. And it’s not reasonable to expect them to be so, either,” said Henry Mahncke, PhD, chief executive officer of Posit Science, maker of the brain training software and app BrainHQ.

Even the highest-rated health apps may not be supported by science. They just happen to be the most popular — which encourages downloads and helps them stay at the top of the charts.

However, there are a few signs to look for in a high-quality app.

If an app is something your doctor might ask you to use — like one that identifies or monitors a health problem — it may require FDA approval.

Apps that track your steps, heart rate, sleeping patterns, and other health indicators should have been scientifically tested to make sure they are accurate.

Even brain training apps should undergo scientific testing, especially if the company claims they can improve your memory, reduce your risk of dementia, or offer other brain boosts.

This is the approach that Posit Science has always taken.

“When we started this company, we knew that not only did we want to design brain training programs that were highly sensible from a scientific perspective,” said Mahncke. “We also knew from the very first day that we wanted to validate and show that these programs work — the way a new drug or new medical device would.”

On its website, the company lists more than 100 published peer-reviewed studies that tested BrainHQ in a variety of situations — with benefits like improved processing speed, memory, and attention.

Choosing a high-quality app

But what about all the companies that don’t care as much?

Especially the ones that claim their products are science-based — but aren’t — and throw some “sciency” language on their website just for show.

Neinstein suggests that before you buy a health app you ask yourself: “Is there the potential for risk with the type of application I’m choosing? Or is this pretty harm-free?”

For example, if an app that tracks your step count doesn’t work right, you’re only out a few bucks and the time it takes you to write a negative review in the app store.

But if you have diabetes and an app that is supposed to help you choose the best dose of insulin is inaccurate, it could be “potentially life-threatening,” said Neinstein.

Beyond that, you may be on your own.

“There’s not enough evidence out there, there’s not enough research that has been done to show which apps work and which don’t,” said Neinstein.

He emphasized, though, that in spite of the bad apps — you might say apples — out there, mobile and digital health is not “all good” or “all bad.”

Some comparisons of health apps have shown up in medical journals — like one done on brain training apps and another that looked at insulin dose calculators.

Not many consumers, though, will read a medical journal before downloading an app on their smartphones. These reviews can also take months to be published, by which time some of the apps will be outdated.

Mahncke said that what’s missing are side-by-side comparisons of brain training and other health apps done by an independent group, with an eye toward the science behind the apps.

But does it really matter if you buy a $2 or $9 health app that doesn’t work?

Mahncke thinks so.

“The problem is that this science offers tremendous potential for human health,” he said.

If an app that could reduce someone’s risk of developing dementia gets “lost in the tidal wave of nonsense” found in the app stores, people may miss out on a chance to improve their health.

But in order for people to find these rare gems, they will need help choosing the best health apps.

Maybe somebody will build an app for that.

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