When You Think You’re Not A Medical Device But You Really Are

It used to be that if you wanted to know anything about the state of your health you would have to go to a doctor for a check-up.  Boy is the world is a different place from when I grew up. 

Today there are wearables, apps, smartphone add-ons and sensors that will save you the trip.  These things let you monitor every part of your day, from the quality of your sleep to the stress in your life.  You can keep your heart healthy, your weight optimal and improve your posture.  You can learn how to exercise right and meditate most effectively.

We’re living in the information age, so there you go.

But under what heading do all of these health-informing pieces of technology get categorized?  Is a wristband a medical device?  What about a phone app?  If I put my hand on my child’s forehead and determine he has fever, am I a medical device?  Maybe they all just provide medical reference and promote health awareness, which is very different.

It seems that it largely comes down to one thing: marketing and promotion.  (That’s really one thing.)

The Attorney General of New York just concluded a year-long investigation of mobile health applications by settling with three companies, including the Israeli company, Matis. Their app, My Baby’s Beat, is, according to their website, a prenatal listener, that allows one to listen, record and share a baby’s heartbeats and other sounds. The app uses only the device’s microphone, with no accessory required.

Matis previously claimed it could turn any smartphone into a fetal heart monitor, despite the fact that it has never been approved by the FDA.  That’s a no-no.  

Also, although Matis encouraged consumers to use My Baby’s Beat instead of a fetal heart monitor or Doppler, it never conducted, for example, a comparison to a fetal heart monitor, Doppler, or any other device that had been scientifically proven to amplify the sound of a fetal heartbeat.  Ouch.

The big problem is that providing inaccurate or misleading results can be harmful to consumers by giving false reassurance that a person is healthy, which might cause her to forego necessary medical treatment and thereby jeopardize her health.  Conversely, they can incorrectly diagnose a medical issue, causing a person to unnecessarily seek medical treatment.

Sadly, the settlement cited a review on the Google Play Store by a woman who reported that the app indicated a heartbeat, when a sonogram determined there was none.

In addition to a $20,000 fine, the settlement required Matis to amend deceptive statements about their apps and modify their privacy policies to better protect consumers, while also making clear that their apps are not medical devices and are not approved by the U.S Food and Drug Administration.  It seems they’ve taken care of that.  Lesson learned.

 

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