September 27, 2013

Hold the Phone: FDA to Regulate Smartphone Health Apps?

From: RegBlog

Silki Patel

The Food and Drug Administration (FDA) has set its eyes on the fast-growing mobile health app market, estimated to reach $26 billion by 2017.

A recent FDA action has reignited uncertainty over the agency’s treatment of mobile health apps.  Earlier this year, the FDA sent a letter to a firm called Biosense, questioning the company’s lack of federal regulatory clearance for uChek Urine analyzer, a kit that allows consumers to use their cell phone cameras to read color differences on test strips designed to detect unhealthy levels of protein and other substances in urine.

Biosense’s kit is used with a smartphone camera and app, available on both Apple’s iPhone and Verizon Android Phones, “to process results for nearly 14 substances and determine the risk for more than 60 diseases.”  The FDA has not sent letters to any other app makers, according to Erica Jefferson, an FDA spokeswoman.

Mobile healthcare, also known as mHealth, stands to become the “biggest technology breakthrough of our time,” according to U.S. Secretary of Health and Human Services Kathleen Sebelius.  Today, mobile apps are already addressing health problems.  For example, BlueStar, a doctor-prescribed app by Welldoc, provides coaching messages for diabetics based on real-time blood glucose values and trends.  In all, an estimated “25-30% of today’s doctor visits could be replaced by phone, text, and digital check-ins.”

Domestic healthcare spending in the United States is so large it is difficult to fathom.  As a result of the high costs of traditional healthcare, consumer appetite for mobile health apps is likely to grow.  According to Business Insider, the “top 10 mobile health applications generate up to 4 million free and 300,000 daily downloads.”

By 2015, an estimated 500 million people will be using healthcare mobile applications.  Combined, the increasing health spending and consumer mobile appetite are set to transform the health industry.  There are already 17,000 mHealth applications available in major app stores.

However, the FDA has not completed guidelines for what regulatory requirements will apply to app makers nor has it indicated at what stage in development an app will require regulator approval.  The FDA drafted – but never finalized – guidelines in 2011 that would require mobile apps that diagnose or prevent disease to meet similar quality and safety standards as other medical devices, such as ultrasound machines.  Regulatory uncertainty has thus been an area of concern for members of the mHealth industry.

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