Some Health Apps a Worry for FDA, Doctors

Nancy Crotti

August 4, 2014

2 Min Read
Some Health Apps a Worry for FDA, Doctors

Want to measure your blood pressure? There's an app for that - more than one, actually - and they have doctors worried sick.

A story on recounts physicians' concerns that patients will use substitute certain apps, such as Instant Blood Pressure or Instant Blood Pressure Pro, for traditional blood pressure testing. These apps claim to take your blood pressure using your iPhone, no cuffs required.

A user would have to click on Instant Blood Pressure's support link to read a disclaimer that reads: "At this time, Instant Blood Pressure is intended for recreational use only. It is not a medical device. Consult a doctor if you have any health concern."

A click on Instant Blood Pressure Pro's support link brought up a page of ads with "related" links for life, health and car insurance.

A recent piece from Politico notes that there are more than 100,000 health apps on the market.

Editorial writer and attorney Nathan Cortez writes that while some mobile health are helpful, including one to measure glucose levels and another that records electrocardiograms and transmits the readings to their cardiologists, others may not be.

The federal government has taken note.

"The FDA is focusing on a small subset of mobile apps that are medical devices and present the greatest risk to patients if they do not work as intended," a U.S. Food and Drug Administration spokesperson told Wired. "For that subset, the FDA might take action were it to determine that an app does not meet relevant regulatory requirements. But our typical approach would be to allow a firm to come into compliance voluntarily before taking enforcement action."

The FDA must approve apps that are intended to measure vital signs before they can be sold in the U.S. The agency cites industry estimates that 500 million smartphone users worldwide will be using a healthcare application by 2015, and by 2018, 50% of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.

About the Author(s)

Nancy Crotti

Nancy Crotti is a frequent contributor to MD+DI. Reach her at [email protected].

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