FDA and Regulation. The dangers of crying Wolf.

Everyone seems to think that mHealth is about to take off.  mobihealthnews.com’s recent roundup of analyst predictions estimated sales of around $4 billion per year by 2014, and my own more fanciful review of potential savings ran into tens of billions of dollars.  Network Operators are setting up mHealth divisions faster than you can say “long term chronic condition” and the outpouring of mHealth apps for smartphones continues to grow exponentially.

It has all of the characteristics of the next technical bubble, but with the added benefit that, if we can make it work, it might actually save our healthcare systems from terminal meltdown. We need the disruption that mHealth will bring.  As Clayton Christensen points out in his seminal book – The Innovator’s Prescription, the only way we are going to effect a major change in healthcare is through the introduction of new, parallel business models to challenge those that our current healthcare structure is built on.  That will need new technologies that provide more effective diagnosis of symptoms, as well as devices that encourage personal participation in healthcare by putting monitoring and health records into the hands of patients.  Which are exactly the areas being targeted by the mHealth community.

However, there’s an invisible gorilla in the mHealth room that could consign the whole enterprise to history.  It’s called the FDA.  The FDA has the ability to apply regulations that would choke the development of mHealth.  Like all regulators, the FDA moves slowly – far more slowly than the emerging mHealth technology.  It is important for the industry to engage with it to reset the levels of regulation for mHealth.  What is worrying is that most of the noise around regulation is not about that resetting of expectations, but scare-mongering about the possible reaction of the FDA to an expansion of connected healthcare and new delivery methods.  It’s important that manufacturers understand the barriers that regulation might bring, but we’re at risk of crying “Wolf” to the extent that mHealth may never happen, or else only evolve outside the U.S.

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Obama – Raising the cost of Personal Healthcare?

Today should have been a day for celebration, as the US Senate passed the Healthcare bill.  But two strands of it – the device tax and product registry seem aimed to make barriers for the deployment of personal healthcare.

I don’t think anybody would argue against the need for reducing the cost of healthcare.  There are obviously many efficiencies that can be brought into the system, whatever and wherever that system may be.  But most agree that increasing the individual’s focus on wellness is an important foundation to that cost reduction.  To make that happen we need to make personal health devices cheaper and more accessible.

That’s where this bill betrays itself.  Hidden amongst the headline grabbing stuff are two clauses that may well help to slow the speed at which these devices come to market – a tax on each and every device, and a proposal for the FDA or similar body to administer an Orwellian control over what comes to market, potentially stifling innovation.  If this really is a bill for reforming healthcare, that’s a strange route to take.

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FDA – mHealth’s Angel or Demon?

In the rush to get a chunk of Obama’s healthcare billions, any industry with the slightest idea about remote healthcare is doing their best to claim that they are the rightful recipient of the cash.  The latest of these is the CTIA, who recently held a policy forum featuring medical experts and government officials.  In it they touted the promise of mobile health applications that would drive down costs and improve the quality of care.  They admitted that they didn’t have a policy yet, but they certainly want a chunk of the action for their members when the $19 billion dollar treasure chest is opened.  They’re not alone, but amongst all of the feverish lobbying going on in Washington there seems to be a total neglect of the role of the FDA.  Instead there’s a general opinion that a good PowerPoint and drinks for enough politicians will overrule any regulatory requirements.

mHealth has been (and still is) a long time in coming.  There’s a whole host of reasons for that.  It’s trying to grow up in a room full of 800 pound gorillas, amongst them technology, resistance from the medical profession and a lack of standards.  But hiding behind the visible 800 pounders is the big brother of invisible gorillas – the Food and Drugs Administration, fondly know as the FDA.

The FDA is responsible for regulating medical devices and services in the U.S.  If they say a product or service can’t be offered, then it’s effectively dead.  It provides a barrier to entry for manufacturers and services in the medical and health arena.  So far, it’s had little to say about many of the visions of the mHealth industry, but there is no doubt that it will.  I recently saw a presentation that outlines just how wide its powers and scope are.  And they are wide.  If the FDA enforced the most aggressive interpretation of its rules it could probably stop sales of the iPhone today.

I’m sure it won’t.  This isn’t a rant against the FDA, but about the relative naivety of many of the organisations claiming to offer solutions in their quest for a part of the new healthcare pot.  The future of mHealth would be far better served if organisations like the CTIA concentrated less on the high level fanfares and started engaging in informed debate about how the regulatory regime needs to change.

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