I was going through the Apple App Store’s Health & Fitness category last week, when I noticed an interesting health app that had made it into the top 10 “Paid” and “Top Grossing” sections.1 The app’s name is: “Instant Blood Pressure — Monitor Blood Pressure Using Only Your iPhone”.

The following screen shots show the initial description you get of the app in iTunes or your iPhone.

The app touts a patent pending process, and states it’s developed by a team from Johns Hopkins — going on to say how Johns Hopkins is a leader in health innovation.

The app costs $3.99 to download — and–as you can see in the above descriptions I have taken screen shots of — promises to measure your blood pressure using just your iPhone. I downloaded the app, and there were two tasks it required. First, it asks you to place your finger on the camera (measuring your heart rate), and second, you have to place your phone’s microphone on your heart.

There are no disclaimers in the app stating how the app might not work, is in testing mode, or is for entertainment purposes.

Rather, the app’s introduction screen touts how you don’t need to use a cuff. You just need your iPhone.

So, are people actually using this app? Yes! If you look at the comments section in iTunes it’s clear this app is being used to manage people’s hypertension.

The first comment above is the most interesting. It basically lets everyone know again how the app works, and how it’s from Johns Hopkins University (it’s actually not from Johns Hopkins University, I’ll explain that later).

There is even a comment from a medic (firefighter) that states they are in the medical field and how they feel confident using the app.

There are over 30 comments about the app that I have attached to the end of this post for viewing. In general, the comments give a favorable review of the app, with many people stating how they are using the app. There are some terrifying comments, of how people state the app doesn’t correlate — with one person saying their BP cuff was giving them 170 systolic readings while the app was giving normal readings. There are also comments implying how this is a fake app, how it’s ridiculous the developers are charging $3.99 for something like this, and how it should be removed from the App Store because it can cause serious harm.

So can your iPhone accurately measure your blood pressure by using your phone’s camera and it’s microphone?

You get the answer when you click the “more” section in the description. The last few lines of the description explain everything.

“Instant Blood pressure is for entertainment purposes only”

So how does an app make it into the top 10 paid section, competing among the likes of “Fitness Buddy”, “7 minute workout challenge”–and apps that even Apple has pushed from a fitness standpoint — all while explaining it will measure your blood pressure in a few paragraphs and then at the end give a line saying it’s “for entertainment purposes”?

I reached out to the developers of this app to get a better idea. Ryan Archdeacon is the founder and CEO of Aura Labs — they make: “Instant Blood Pressure–Monitor Blood Pressure Using only your iPhone”. I had a phone conversation with him and also exchanged several messages via email.

Basically, he told me he is a biomedical engineer trained at Johns Hopkins University. The app itself is not from Johns Hopkins University even though it is somewhat implied in the description section (in the comments section people actually think it’s from the University). Ryan wanted to stress to me how the app is currently only for entertainment purposes and shouldn’t be used by people to measure their blood pressure. When I asked him why there is no disclaimer in the app, he felt this is something that might be included in future updates.

He was very straightforward with telling me that he could not explain how the app works — basically stating how it’s a patent pending process that he can’t get into at all. I was particularly interested to find out why an app that is in “beta” mode, or for entertainment purposes only is charging $3.99, and he stated the following:

We have given a lot of thought to our pricing model. Of note, there are broad sections of our test data that fall well within the accuracy parameters laid out in the my last e-mail. However, we have identified certain areas that do fall outside of those parameters and other weaknesses in need of improvement. So the app certainly does work for the majority of our users as reflected in our data and our user feedback. With that said we have been definitely taking feedback regarding our pricing into our considerations for potential future adjustments.

Ryan requested I not do an article on their app — stating how they did not feel the app was ready for press yet. He told me that if I held off on publishing a story, he would give me an exclusive when they have more data on the app.

According to articles in the American Heart Association and the Cleveland Clinic, there is no correlation between blood pressure and heart rate. I’m not going to comment on the physiology of heart rate and blood pressure correlation (the app implies that it measures your heart rate as a parameter for blood pressure), or my personal opinions on using an iPhone microphone to measure your blood pressure.

If you tell any Physician that you’re using your iPhone’s camera and microphone to measure blood pressure, they would recommend against it. I was hoping to have solid data from Ryan to back up the claims, and he stated they had based the app on 254 readings across 181 subjects, with ages ranging from 18 to 105. No literature to back up the app was or has been provided.

Many of my colleagues in the mobile health ecosystem think this app is atrocious and is an example of what sets us back in the world of mobile health. They think it’s just a marketing scheme, a modified bait and switch scheme that promises to measure your blood pressure, but then gives one line stating how its for entertainment only. However, I’m going to give Ryan Archdeacon and the Aura Labs team the benefit of the doubt, maybe they actually are working on figuring out how your iPhone’s camera and microphone can detect your blood pressure.

If they truly are working on algorithms that utilize your phone’s sensors, I’m puzzled by the following:

1) Why isn’t there some sort of white paper or publishable information about the results of the app.

2) Why isn’t there a disclaimer within the app so people who download it understood it’s for entertainment only?

3) Why are they charging $3.99 for an app that is not supposed to be used to measure blood pressure. Let me emphasize that, Aura Labs says you shouldn’t use this to measure blood pressure, but still want to charge you to use the app.

4) Why would they not want press about this app?

My formal recommendation is for this app to be removed from the iTunes store. If you don’t think your app is ready for press–if it can’t do what the title states it can do–then it shouldn’t be available to download.

We have written extensively about how the FDA is getting into the arena of regulating mobile apps. With the one line disclaimer about how the app is for entertainment purposes, the Aura Labs team is trying to avoid FDA regulation. They have probably skirted it by that line and are also probably trying to avoid FTC regulation. A few years ago, we wrote about how blue light therapy apps were making false promises, and a few months later the FTC came in and forced those apps to be removed. Aura Labs is walking a dangerous tightrope with the FTC.

The FDA and FTC aside — what about the ethical dilemma this app presents? Yes, there is a one line disclaimer in the description of the app. However, you have to click on the “more” section to view it, and it’s buried at the end. There is no disclaimer in the app itself. What if one person out there with hypertension is actually using this app to monitor their blood pressure — the comments section show there is at least one. What if that one person has a horrible outcome — there is huge potential for harm if this app is not used correctly.

When I first saw this app, I was terrified. I practice medicine in the Emergency Room. I see what poor blood pressure management does on a daily basis. I see people arrive to my ER non-responsive, on the verge of dying, due to hemorrhagic strokes secondary to blood pressure that isn’t controlled. I’ve talked to family members telling them how their loved one died because their blood pressure was too high, resulting in a catastrophic failure of one of their organs.

Blood pressure management is not a game. This is real life. This is not “entertainment”.

More iTunes Reviews of the app, 3/5 star rating currently, and 4/5 star rating on Google Play.