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Bio & Life Sciences

Should the FDA Regulate Medical Apps?

At the Consumer Electronics Show last January, the seventh most popular gadget in a popular vote was a wireless glucose meter for diabetics,  Telcare BGM.The device reads the glucose level in a drop of blood on a test strip and wirelessly transmits the results to an online database. Telcare’s gadget is just one of a whole raft of mobile health monitoring devices that have come to market during the past year or two. They range from blood pressure cuffs, pulse readers and other types of glucose meters, but all have one thing in common: they must connect to a smart phone.

This rapid evolution of the mobile health market (often referred to as mHealth) stands in sharp contrast to the usually glacial pace of medical development. It can take years of clinical trials and cost hundreds of millions of dollars to bring a new drug or medical device to the market, and only 35 percent of hospitals have implemented electronic health records systems. The fast uptake of mHealth, by contrast, promises to quickly make medicine cheaper and more accessible. But a question looms over these innovations: Are mobile apps safe?

To ensure that they are, the U.S. Food & Drug Administration (FDA) wants to regulate certain types of mobile apps. Ideally this should be a win for patients, but the regulatory world is rarely ideal. App makers are worried that the FDA, already stretched by budgetary constraints and ballooning responsibilities, may not be able to keep up with either the number of apps or the rapidly advancing technology.

Their concerns are grounded in an uncomfortable precedent. Back in November 2009 the FDA held hearings on how pharmaceutical and medical device makers could participate in social media. Over two years later, in January 2012, the agency finally issued a draft guideline, on just one aspect of social media: “responding to unsolicited requests for off-label information about prescription drugs and medical devices.”

With mobile medical apps, the FDA is very much playing catch up to one of the fastest growing segments of this market. There are an estimated 23,000 medical and health care apps for iPhones and Android devices already available, and a recent survey by Float Mobile Learning Research found that nearly 80 percent of U.S. consumers are interested in mobile health solutions.

The FDA started looking at mobile apps in 2009 and has approved a handful, despite the lack of formal regulations. Mobile MIM, made by MIM Software, is one of the pioneers, an app that turns an iPhone or iPad into a diagnostic medical instrument that a doctor can use to read an EKG, MRI or other type of scan. It took MIM almost 2 1/2 years to win FDA approval.

In an effort to set a clearer pathway to approval going forward, the FDA issued proposed rules for mobile medical applications in July 2011; they have yet to be finalized. The 30-page draft proposes regulations for two categories: apps that help doctors make a specific diagnosis, and those that transform a mobile device into a currently regulated medical device, such as an EKG machine, stethoscope, or glucose monitor. The agency did get crucial support for its efforts on July 9 when President Obama signed into law the bipartisan FDA Safety and Innovation Agency Act (s.3817), authorizing the development of mHealth regulations. The law also mandated the Department of Health and Human Services (HHS) to develop a report on an “appropriate, risk-based regulatory framework … including mobile medical applications.”  The FDA said it expects to issue regulations by the end of 2012.

At FDA hearings on the proposed mobile app regulations in September 2011, there was both fervent support and opposition. Many physicians say they are eager for an FDA seal of approval that will protect patients, make mobile adoption easier and clear the way for payment by insurers who so far haven’t figured out how to reimburse. App makers say they aren’t against the federal oversight completely, but they fear both the glacial pace of the FDA and regulatory creep.

Congress, at least on the Republican side of the aisle, is on industry’s side. On April 3, 2012 six GOP Congressmen sent a letter to the FDA cautioning against slow and inconsistent regulations: “We are concerned that applying a complex regulatory framework could inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care and allow the health system, as a whole, reduce costs and improve quality.”

Some regulatory complexity is inevitable, and not necessarily a bad thing. More worrying, though, is whether the FDA can find the money and the staff expertise to vet medical apps in a timely fashion. One solution could be for mobile app makers to follow the lead of the biopharma industry, and essentially pay the FDA for such oversight. The drug industry has been paying user fees (officially called PDUFA fees) to the FDA since 1992; in 2011 those fees totaled $707 million and covered 65 percent of the agency’s budget for evaluating new drugs.

App makers could also do an end run by regulating themselves. There are several professional organizations that could take on standard-setting duties, such as Health Information and Management Systems (HIMSS), a non-profit focused on health IT.  Or there could be yet another market based solution—the emergence of medical app “stores” like Happtique Inc, founded by health professionals in 2010, which is developing a set of criteria to evaluate medical apps.

Ideally a combination of federal and industry oversight will emerge, soon, to oversee medical apps and ensure their safety. The failure of a glucose monitor is a lot scarier than an angry bird.

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One Response to “Should the FDA Regulate Medical Apps?”

  1. step says:

    The information in the blog is very informative and effective one.I want to share about the smart app “Pediatrics Made Easy”.

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