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.
Read More