Top 10 downloaded iPhone health app can cause significant patient harm

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.

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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.

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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.

Screenshot 2014-07-14 11.00.21

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.

Screenshot 2014-07-14 11.20.21

“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.

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Author:

Iltifat Husain, MD

Founder, Editor-in-Chief of iMedicalApps.com. Emergency Medicine Faculty and Director of Mobile App curriculum at Wake Forest School of Medicine.

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  1. As of publish the app is currently in the top 30 “Paid” section of the Health and Fitness section of the App Store, and the top 30 for “Top Grossing”.

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21 Responses to Top 10 downloaded iPhone health app can cause significant patient harm

  1. Allen Holloway July 14, 2014 at 2:11 pm #

    Unless they can present scientifically validated data to the contrary, this has to be considered a scam, as they are making a ton of money from people who think it is real. If this is indeed just “a game”, that should be presented in bold type at the beginning of the description. If someone was hurt by assuming that their data was valid, I suspect they might be able to sue the company, so I think they should be careful. However, with the large sums they have already made from this “game”, they can probably shut it down, and just run off with the money.

    • Iltifat Husain, MD July 27, 2014 at 7:56 pm #

      I agree — I truly wonder what would happen if someone did get injured using this app. What would be the repercussions to not only the developer — but one wonders if Apple or Google would be culpable as well? That’s one of the things that’s so disappointing w/ this — if someone does use this app inappropriately due to how the developers have marketed the app (initially not having any type of disclaimer in the app) — and they have a bad outcome — it would set all the health apps back. Especially the ones who are trying to get FDA approval before use, and putting in the appropriate grunt work and going through the right channels.

  2. Devin July 14, 2014 at 5:00 pm #

    Well done, Iltifat. As a Physician in Internal Medicine, I would be horrified for a patient’s safety if they used this app for hypertension management. It has no validity at all. I hope this snake oil is removed before someone dies because of it.

    • Iltifat Husain, MD July 27, 2014 at 7:59 pm #

      Thanks, I really am giving the developers the benefit of the doubt when they tell me they actually are working on some algorithms to make this happen — my beef and issue is w/ the lack of disclaimers, and making people pay for something that isn’t supposed to be work. So many ethical dilemmas with this app.

  3. Mindaugas July 15, 2014 at 7:16 am #

    Great, now people will write in to ask me why the hell my app (which is simply a logging/charting tool for BP measurements) can’t do magic. Thank You very much dear Aura Scammers Labs.

    • Iltifat Husain, MD July 27, 2014 at 7:59 pm #

      ^ hilarious

  4. Dennis July 16, 2014 at 8:13 pm #

    I agree that it seems strange.

    On the other hand, it was only 110 years ago that skeptics questioned Nikolai Korotkov when he claimed he could measure blood pressure by listening to the quality of sounds at the elbow while deflating a cuff on the upper arm.

    I have to wonder why Dr. Husain didn’t simply share some personal results. A few erroneous examples would have quickly debunked this app.

    • Iltifat Husain, MD July 17, 2014 at 2:21 pm #

      If I had done that, I would be culpable of doing the same thing the developers of this app are — presenting a nonscientific manner to results. Since I don’t have hypertension, the variance of my BP compared to their method would be subjective. Further, there are ample examples in the screen shots I presented that show people with incorrect BP results.

      BTW Nikolai Korotkov did present his findings in an academic manner, consistent w/ the scientific method — while there were skeptics, he didn’t just randomly put something out there. He had data to back up his claims.

      • Dennis July 17, 2014 at 7:42 pm #

        I agree that Korotkov answered skeptics with scientific data including animal studies soon after his initial description of his method. However, his initial presentation was a description of the method. The data followed soon after.

        I should have said “shared personal observations” rather than “shared personal results”. I was suggesting it would have been simple for you to do a few A-B comparison with different people having BP measured with a cuff. Your personal observation of the failure of the device to work would have been more convincing than the online observations of “Fergie’s mom” and “JMRBR”.

        The accurate measurement of blood pressure by cuff and Korotkov sounds can be challenging. It is notoriously dependent on proper cuff fit. It also may be unreliable if vessels are calcified.

        It is well documented that the blood pressure measured by an arterial line, cuff/Korotkov sounds, and oscillometric method (eg Dinamap) may show considerable disagreement.

        I’ll keep an open mind, but remain skeptical.

        • Iltifat Husain, MD July 17, 2014 at 9:25 pm #

          It’s not the systolic / diastolic that matters — it’s the MAP at the end of the day. When it comes to arterial line placements, and also cuff — studies have shown the MAPs overall are pretty consistent. Often times people think use of an a-line is critical to get the “exact” BP, not really. Again, it does no good for me to use the device as all the measurements I was getting were normotensive with hardly any variance.

  5. josh July 21, 2014 at 9:00 am #

    So what are we going to do? Why talk about this sham rather than take it down? Apple is very sensitive to issues of fraud, legal risk, and their brand. How does one pursue getting garbage like this out of circulation to the public?

  6. josh July 21, 2014 at 11:08 am #

    Other interesting note: there is an app Instant Blood Pressure Pro. It has the same description (the reference to Johns Hopkins, the bogus disclaimer, and more), yet it is by a different developer and is lower in price at $1.99.
    –Josh

  7. josh July 21, 2014 at 11:58 am #

    I just clicked my way through the Apple feedback and contact us pages as best I could for the App Store and submitted the following:

    Dear Apple,

    There is an app “Instant Blood Pressure Monitor” which claims to measure a person’s blood pressure just with an iPhone and without a cuff. This is not physically possible. It is dangerous to permit this app to persist in the App Store. The free and pro versions each offer slightly different disclaimers (for “entertainment” in one case, for “entertainment and fitness” in the other). There is no disclaimer in the world which dismisses the fact that an app which claims to measure a person’s blood pressure will be interpreted by the public to be a blood pressure measuring tool. Apple may be held accountable for this since you screened the app and cleared it. As Apple has made clear to the developer community, the FDA has high standards for apps which use the iPhone as a medical device. Check this app out carefully — it certainly uses the iPhone as a medical device. Also the app alludes to Johns Hopkins yet has no relationship with Hopkins and no medical literature to back up the validity of the app to measure blood pressure.

    https://itunes.apple.com/us/app/instant-blood-pressure-monitor/id835333129?mt=8

    I urge you to remove both free and pro versions of the app as soon as possible.

    Please let me know how you handle this case.

    Best regards,

  8. josh July 27, 2014 at 10:05 am #

    Even though Apple has said it wants to be careful about medical apps, that’s not my experience thus far bringing this BP app to their attention. I tried two different customer feedback links for Apple and iTunes, but got disinterested responses from Apple. Basically each said, “not my department”. Quite disappointing.

    What are others doing?

    • Iltifat Husain, MD July 27, 2014 at 8:01 pm #

      Josh — could you copy and paste their response? Would be really interested to see what they are saying. Thanks!

  9. Goran Bambič August 1, 2014 at 5:35 am #

    These types of applications can frankly be compared with a profit of war. It is sad that someone’s life is to be taken as a hostage to earnings. The only solution is to talk about it openly and raise awareness among users. At the same time, it is necessary to launch medical applications that will be useful, professional verified and will increase the quality of health care. Technology is intended to provide improvements, but unfortunately, some of developers advantages for rapid enrichment, irrespective of the fact that this endangers the lives of people.

  10. Itai August 10, 2014 at 4:53 am #

    Hi guys

    I must say that I found this discussion interesting, specially on the scientific level.
    I found this article “The ear as a location for wearable vital signs monitoring” written by these guys (David Da He, Eric S. Winokur, Thomas Heldt, and Charles G. Sodini) from MIT.

    In their paper they say that:
    “This location (behind ear) offers discreet sensing of reflectance PPG and BCG signals. PPG enables the measurement of blood oxygenation and heart rate, and BCG allows the measurement of heart rate and respiratory rate. With the Valsalva maneuver, it is shown that cardiac output is correlated to the amplitude of the BCG signal. Furthermore, when BCG is coupled with chest ECG, the inverse of the R-J interval correlates to blood pressure. Future work includes designing low noise circuits to sense ECG behind the ear to allow localized blood pressure estimation, and adding an accelerometer to enable orientation calibration.”

    I am not an MD but for my understanding the proof of concept has been published in several occations. Am I correct?
    here is the link to the paper:
    https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CB4QFjAA&url=http%3A%2F%2Fdspace.mit.edu%2Fopenaccess-disseminate%2F1721.1%2F69025&ei=Fi7nU9uYLubgyQOEjICwBg&usg=AFQjCNF09LLTVjZIZonvu2DMjGBdSMPmMw&sig2=BFSg_9QCHuhisi5fBEu7Gw

    • Allen Holloway August 11, 2014 at 12:05 pm #

      Published, but has it been verified? You can publish almost anything, but with new concepts and technologies, it will have to be verified by an independent source. The concepts sound great, but how they are actually reduced to practice may not be quite so simple. I look forward to hearing more about this.

  11. Itai August 10, 2014 at 4:56 am #

    And, by the way, one of the writers of this paper has (supposedly) been hired by apple

    http://www.macrumors.com/2014/05/01/apple-hires-another-wearables-expert/

  12. Lori August 31, 2014 at 8:46 am #

    I have been managing my BP with a cuff my iHealth. I found this app in the iTunes Store and downloaded it. I have been using both for several months. The instant BP app was spot on the ihealth cuff until Thelma’s update. Now it throws off strange readings. It’s enough to scare the tar out of you. I could not find the disclaimers you are talking about. I have emailed the company twice with my odd readings and all I have gotten back is they are working on it.

    • Allen H September 2, 2014 at 12:47 am #

      Blood Pressure is the measurement of systolic and diastolic pressures within the artery. For a technique to be accepted as valid, it must be compared to the intra-arterial pressure. And any new technique, such as this must be verified by at least one independent study. And if it is indirect, again such as this is, the physics of how it works needs to be discussed. Until this has been validated in these ways, it cannot be considered to be an accurate measure of blood pressure, especially when people’s health may be at stake.

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