Hold the Phone: FDA to Regulate Smartphone Health Apps?

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As mobile health industry grows, regulation looms.

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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.

Testifying before the House Subcommittee on Communications and Technology, Jonathan Spalter, Chairman of Mobile Future – a stakeholder group representing technology companies, urged the country to find a way to protect consumers’ safety and privacy without stifling innovation, while providing mobile health application and device developers “a clear understanding of where regulation begins and ends.”

According to the draft guidelines, the FDA would like to oversee mobile medical apps that are “used as an accessory to an FDA-regulated medical device” and those that “transform a mobile platform into a regulated medical device.”  For example, an app that allows a doctor to view medical images on an iPad to make a diagnosis or that turns a smartphone into an electrocardiography (ECG) to detect abnormal heart conditions would be required to meet the proposed guidelines.  According to Bloomberg Businessweek, the FDA aims to finalize these guidelines by the end of 2013.

Regulators will have to grapple with safety issue stemming from mHealth apps.  In a report on the topic by PricewaterhouseCoopers, most patients surveyed said mHealth would improve their healthcare, and most doctors believed widespread adoption of mHealth would be inevitable in the near future.  However, the survey revealed a rift between patients, who want convenience and control over their own health, and their doctors, 42% of whom worried that mHealth would make patients too independent.

They may also have to address privacy concerns.  According to the New York Times, “an analysis of 43 popular wellness apps by the nonprofit Privacy Rights Clearinghouse found that many apps connect to advertising and data analysis sites without the user’s knowledge.”  The study found unencrypted internet connections potentially exposed sensitive data, such as medical and pharmaceutical information, to everyone on the network.

Despite regulators’ recent moves, mHealth app producers seem determined to bring their product to the market.

Biosense turned to the internet to seek out customers willing to pre-order uChek to help the company raise $42,000 by September 10, 2013 to meet regulatory requirements in Europe, as well as comply with U.S. standards.  According to the company website, the expired internet campaign through Indiegogo Inc.’s crowdfunding website brought in only $15,271 of the $42,000 needed.  Yet Biosense has now stopped selling the kit in the United States as its works to seek regulatory approval.