FDA Regulation of Mobile Health Apps is a Real Threat

Do you want the Food and Drug Administration (FDA) to regulate your smartphone? Many in the booming digital health industry are indifferent to the risks of the FDA regulating apps as medical devices. As I noted in a recent Health Alert, the FDA’s current doctrine is to allow most new apps onto the market without regulation. However, this openness is defined only in rules written by the FDA itself, not legislation. Rep. Marsha Blackburn and others in Congress have proposed to amend the law to prevent the FDA from overreaching.

Entrepreneurs and patients who think that the FDA’s current posture is eternal should be aware of a campaign to regulate apps for health. Here’s a recent article from Mother Jones:

Online retailers like iTunes and Amazon offer thousands of apps promising all kinds of real-time information about your body — they can measure blood pressure, take your pulse, track your menstrual cycle, and tell you how well your lungs are working. Mobile health is one of the fastest-growing app categories: According to the consulting firm research2guidance, there are 100,000 mobile health apps on the market, double the number available two and a half years ago. The industry is worth some $4 billion today, and analysts predict that it will reach $26.5 billion by 2017.

Good news? Not according to the author:

Indeed, a number of recent studies have identified medical apps that failed to measure up. In 2011, pharma giant Pfizer recalled a rheumatology calculator app after the company found that its swollen-joint measurements — calculated using self-reported data — were off by as much as half. Even most simple pedometer apps don’t count your steps correctly, a 2012 study found. For a 2013 paper, researchers from the University of Pittsburgh Medical Center tested four skin cancer diagnosis apps…and three of them missed at least 1 in 3 melanomas.

You might expect that the Food and Drug Administration would regulate these apps, and it does — but mainly the ones paired with diagnostic gadgets like, say, a blood-pressure cuff. Even then, its database is full of app-related complaints. One blood-glucose tracker had 59 “adverse events” since 2012 — many involving diabetics who took too much insulin based on false readings and had to be rushed to the hospital.

Most health apps, though, are classified as “informational” or “entertainment” to escape FDA oversight.

This article is a classic of pro-regulatory journalism: Instead of comparing the apps to diagnostic choices that existed before the apps, it compares the apps to perfection. Unwittingly, the article demonstrates the power of self-regulation: Pfizer recalled its rheumatology calculator after evidence of unacceptable errors appeared. Pfizer cannot afford to have its reputation sullied by a poor product, and whichever developer made the app for Pfizer is suffering a loss of revenue from a major client.

There is a movement to get the FDA to regulate smartphone apps. Legislation is required to precisely define the FDA’s authority in this matter.

Comments (1)

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  1. Devon Herrick says:

    The medical apps your doctor uses to monitor your heart failure (remotely on his phone) should be held to a different standard than the pedometer I used to assess my walking distance. Many apps are largely for entertainment purposes. People probably shouldn’t rely on their smartphone camera to assess whether they have melanoma. But I don’t think that general rule of thumb warrants a ban on melanoma apps. There should be a safe harbor for app makers who disclose how they validate their devices to ensure quality; or disclaimers that the melanoma apps is correct only ~65%of the time.