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Feds finally move on mobile healthcare apps

on November 02, 2011 Source: Kauffman Foundation

There’s an old Chinese saying, “May you live in interesting times.”

Healthcare providers who want to put their products and services applications on mobile phones – “mobile apps” in technology lingo – probably wouldn’t argue that point as life certainly is more interesting each passing day.

The core issue for providers who make medical and health-related mobile apps isn’t the technology – that’s been honed almost to perfection as more Americans use smart phones. (Nearly 35 percent of American adults own a smart phone, according to a July 2011 study from the Pew Research Center.)

Instead, the issue at hand is regulation – specifically what the U.S. Food and Drug Administration wants healthcare providers to do in regulating healthcare mobile phone applications.

Business Week notes the federal government’s heightened interest in healthcare mobile apps, pointing to the growing number of such devices out in the marketplace and what Uncle Sam sees as the government’s role in controlling their usage.

Redmond (Wash.) small business Mobisante’s hairbrush-sized ultrasound device, which goes on sale in October, is part of a wave of new smartphone apps and attachments in the nascent mobile health market. In the past eight months, products that turn a phone into a blood pressure monitoring cuff, a CT-scan viewer, and other health-care gadgets have received Food and Drug Administration clearance. The market is tiny but expected to grow rapidly; by 2015, 30 percent of the world’s smartphone users will be using mobile health products, says one mobile market consultancy.

But what’s interesting is who, exactly, is the government protecting – consumers or larger healthcare companies (at the potential expense of the startups who make and market mobile apps)? This again, from Business Week:

Mobile healthcare apps are potentially less expensive. One of the promises of mobile health products is that by building on existing products such as Apple’s iPhone, they can perform the same function as high-end hospital gear for a fraction of the price. Mobisante’s ultrasound attachment, for example, costs $7,495. The images aren’t the highest quality available, but a top-of-the-line ultrasound machine costs as much as $100,000.

Look, there is no solid evidence that the government is out to level the playing field in favor of larger healthcare companies. That said, there is a reason why lobbyists exist and why larger healthcare and medical firms have more power and leverage in Washington, D.C., than the small entrepreneurs who make most of the new mobile apps that are creeping into the marketplace.

With big hospitals and the U.S. Army already looking at mobile apps, the big medical device makers certainly will try to protect their turf. But to what extent is unknown right now.

The good news for all parties involved is that we should know more about how the FDA will regulate mobile healthcare apps by 2012, when the agency is expected to flesh out its policy on mobile apps. That’s good enough for healthcare entrepreneurs, who are well under way in developing even more mobile medical apps that should attract plenty of interest both from commercial (especially hospitals, insurance companies and healthcare centers) and individual consumers – especially since the price is right.

“Big companies of tomorrow are the small companies of today,” notes Cedric Hutchings, chief executive officer of Withings, a company that has developed a $129 blood pressure iPhone app, in comments to Bloomberg.

We do know some of what the FDA plans to do about mobile health devices. The agency has leaked out some guidance on mobile apps, mainly to give manufacturers a heads-up on what apps would draw the most government scrutiny. Anything that directly impacts a patient’s health is sure to be high on that list. Draft guidelines unveiled by the FDA say that smart phones like the iPhone, Blackberry and Android will also be a target of the government’s attention.

The agency has also released a set of guidelines that are worth a look for all healthcare entrepreneurs developing smart phone apps right now.

As thin as it is, that’s the regulatory landscape the FDA – and healthcare companies and consumers – are looking at with sharper focus. We’ll keep you posted, but nobody will know exactly how such products will be regulated until 2012.

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