Where is the 'fine line' between safety and free rein for mobile development?

Hidden among the partisan bickering is the real issue
By Diana Manos
11:00 AM
House Energy and Commerce Committee

Healthcare IT News Senior Editor Diana Manos comments on three days of hearings on Capitol Hill to explore mobile health issues.

Three subcomittees of the House Energy and Commerce Committee just concluded three hearings on mobile health March 18-21, looking for "the sweet spot and that fine line," between patient safety regulations and freedom of innovation, as it was described by Communications and Technology Subcommittee Chairman Greg Walden (R-Ore.) at the opening of the hearings.

How light should the hand of government be? And, how much money would the government stand to gain from imposing a tax, under Obamacare, on health apps that the FDA deems to be functioning as medical devices? The hearings tilted precariously close to the over-played and exhausting partisan bickering that America has grown so sick of, as GOP committee members bore down on witnesses to extract information needed to prove, once again, the government is going where it shouldn’t be.

The balance between patient safety and innovation is a tricky and potentially dangerous one. The truth is: apps are being created – by brilliant, and often very small start-up companies – at a pace with which the FDA is having a hard time keeping up. It is a marvelous time for mobile innovation, as the number of creative apps grows exponentially, with the potential to help every person on the planet live a longer and healthier life. Mobile phones seem to know no bounds – and the impoverished and the wealthy alike have access to them. It is a promising market that can bring healthcare to literally billions of people, overcoming barriers of location and limited healthcare resources.

Some 500 million people will be using health apps by 2015, according to Joe Pitts (R-Pa.), chairman of the House Energy and Commerce Health Subcommittee. Pitts made clear that Congress, particularly his committee, is here to make sure that FDA regulation – and federal taxes – don’t cripple that innovation.

Michael Burgess, MD (R-Texas), vice-chair of the House Energy and Commerce Health Subcommittee, said mobile health will provide future doctors with tools “unparalleled to improve life” and prevent suffering. “We are on a cusp of a medical revolution,” he said. Counter to that, he warned: If the federal government even thinks about regulating something, it almost always ends up being over-regulation.

As it stands now, the FDA is taking a very light touch on mobile apps. Apps that individuals use to take care of themselves, monitor their weight and exercise, for example, are not subject to the scrutiny that a medical device goes through. Apps that are in between personal wellness care and medical devices face looser over-sight. Only apps that claim to provide life-saving diagnostic information to healthcare providers are subject to an FDA review, which the FDA has streamlined to be much faster than the process for pharmaceuticals. Companies with products that fall into the gray area sometimes opt for the FDA marketing clearance, just to be on the safe side, and have reported a two- to three-month review process. It costs a small company a $2,500 FDA fee to get approval for a medical device, but much more for lawyer fees.

According to FDA witness, Christy Foreman, director of the Office of Device Evaluation, Center for Devices and Radiological Health Food and Drug Administration, the FDA will not regulate mobile devices in the future that it currently doesn’t regulate, unless “strong safety signals” would indicate it.

The gray area between obvious personal wellness apps and diagnostic tools is large and murky. There are phone apps today that say they can do urinalysis, check for parasites and determine whether moles are cancerous. These fall into the regulation zone for FDA, and some could be potentially harmful to a patient if the results were incorrect.

The FDA issued a draft guidance for mobile devices in July 2011, and ever since venture capitalists and would-be app developers have been eyeing the market sideways, worried about risk. Without clarity, it’s anyone’s guess.

During the hearings, members of Congress and witnesses argued the FDA is struggling to issue the final guidance – estimated now to be delivered this October – because that guidance would need to be changed on a daily basis as the apps continue to surface to the market.

No one knows what will pose danger in some of these apps. Time will be needed to tell. The FDA, like most government agencies, is cumbersome, not agile. But our world today moves quickly. Technology needs a lot of things – fast – when it comes to policy. Right now, we are watching the frustrating collision of the past and the future, as a government that's more than 200 years old tries to keep people safe, while balancing a technology market's lightning-fast growth. And we all want growth.

Where’s that fine line? It’s a question with no real answer – yet. Government is going to need a remake, a reboot. Where’s that fine line? It’s probably somewhere to be found in the passage of time--and patience. But, let’s hope it’s not in the injury to human life, serving as guinea pigs, along the way.



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