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.

Over the last six months, as the mhealth debate has progressed and new consumer applications have appeared on the market, I have seen a worrying trend for regulators to react to this new technology by making noises about the need for them to enlarge their sphere of regulation.  I’ve already argued that if consumer healthcare is to flourish we need a new patient manifesto that does exactly the opposite.  There are positive things happening – groups like the Continua Health Alliance are helping the FDA to understand the implications of mHealth, but that’s not a message that much of the industry is hearing.

Instead, legal firms and regulatory consultants are increasingly talking up the dangers that may exist within the compass of existing regulation.  Its effect is to reinforce the view that regulators are evil tyrants who may kill your business.  It may be implication and surmise, but it’s sowing exactly the wrong message that we need if we’re going to encourage disruption. 

If you’ve been reading the mHealth blogs or attending conferences, you’ll have come across the excellent articles by Bradley Merrill Thompson.  If you haven’t, you need to join some LinkedIn groups dealing in wireless or healthcare.  I’d urge you to do so, as he speaks a lot of sense and probably knows more about the FDA and its attitude to new technology than anyone else.  As well as being eminently knowledgeable, he’s an enjoyable speaker.  He wowed his audience at the recent Continua Summit and had them shaking in the corridors as they jumped at the imagined sound of FDA bogeymen behind every coffee urn.

Like his namesake, Bradley likes lobbing bricks to wake his audience up.  His message is that the FDA’s existing charter is so wide that the organisation could, if it wanted, regulate any device with a medical purpose, or indeed any part of that system.  If that seems like make-believe, it’s not.  It is deeply worrying to discover just how wide its remit actually is, and even more so to learn what its aspirations are in terms of increasing its sphere of influence.

For the medical industry we have today, that’s not necessarily considered to be a bad thing.  As with all regulation, the FDA helps to maintain the status quo, not least by providing a barrier to new entrants.  However, at a point where the industry needs disruption, that aversion to change threatens to stifle or deter innovation. 

To change that attitude, we desperately need to attract new entrants into the industry, as they have the most incentive to lobby for regulatory change.  It’s an approach that has risks – it will almost certainly mean that we let in some of the more dubious ends of the medical spectrum.  But the alternative – maintaining, or even increasing the current level of regulation, will inhibit disruption and lead to a system that cannot serve the changing population demographics. 

I’ve argued that if personal healthcare is to move forwards, we need less rather than more regulation.  A level of dodgy, alternative mHealth may be the price we have to pay if we are going to make serious progress.  And regulators will hate it, as not only will it potentially remove some of their powers, it also means that new entrants, who are not part of the established medical club will try to tell them how to do their job.  But to achieve any of this, we need to persuade manufacturers outside the health sector to come and join in and help put pressure on the regulators.

Experts like Bradley are telling the story as it is, warning manufacturers new to the market of the potential issues with regulation.  However, without any firm signs of movement from the FDA, endlessly repeating the warnings of impending doom sends a signal to new entrants to avoid the market, or at least the US market.   As a result, I worry about the number of companies that are should be thinking about entering the healthcare market, but are putting their plans on hold.  Without their voices, it will be slower and more difficult to lobby for regulatory change.

We need to ensure that message gets across, but that message needs to be used to argue for a reduction in regulatory power, rather than putting the fear of God into potential disruptors.  Otherwise we risk stopping investment and innovation.

Patient centric and regulated medicine currently live at diametrically opposed ends of the regulatory scale.  The patient centric end needs more proponents to push its cause.  There is much that the mobile industries can bring to the table, as their business model is firmly based on being user centric.  They need to be encouraged in their new foray into healthcare and taught how to engage with the regulators to find common ground.  Not worried, otherwise they will put their effort into other ventures.

It is, of course, far easier to live with the limitations imposed by a regulator and make good consultancy income from advising companies on how to work around them, rather than getting the regulators to move to meet the market demand.  As Bradley puts it in one of his presentations “Arguing with a lawyer is like mud wrestling with a pig: after a while you realize the pig actually enjoys it.”  But mHealth needs those barriers to be moved, and to achieve that we need to encourage as many companies as possible to come to the table.  It may be hard; it may take time; but if we just stress the difficulties and dangers we may never attain that critical mass, which may endanger the whole future of mHealth.