Creative Connectivity

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.

Full Bluetooth low energy standard published

This week, at the Bluetooth annual All Hands Meeting in Seattle, the final draft of the new Bluetooth low energy specification was made available. Last December, the core specification for the low energy radio was adopted, allowing silicon vendors to start their production process, so that chips would be available as soon as the rest of the specification is adopted. This week’s release allows software and application developers to begin work on designing the new ecosystem of products that will be use Bluetooth low energy.

Outside the confines of the technical working groups, Bluetooth low energy is still a fairly well kept secret. Yet it has the potential to overtake Bluetooth usage in just a few years, growing to a volume of multiple billions of chips per year. It is the only wireless technology that has the potential to challenge and surpass the shipment volumes of cellular. Yet even within the Bluetooth community, there are many that have not yet understood this potential.

One of the reasons for that lack of understanding is that Bluetooth low energy is a wireless standard for a new generation of applications. Every previous wireless standard comes from the mindset of being a cable replacement which connects devices that never change their behaviour. That is true even if there’s a mesh involved. And it’s the way that most products were designed until a year or two ago.

Two things have changed that. The first is the concept of machine-to-machine communications where products connect directly to the Internet. The second is the emergence of the Apps store, where handset owners can download and install new features every day. Bluetooth low energy has a new architecture that fits both of these models. Even more importantly, it allows them to converge. As such, it is the first wireless technology designed for the second decade of this century. Here’s why…

Can mHealth save the NHS?

There’s an election looming in the UK, which is causing problems for the political parties. Everyone knows that we need major public spending cuts, but no politician is going to risk votes by committing to anything too great. So everyone is carefully skirting the issue, particularly where the NHS is concerned. The British public have a love-hate relationship with the NHS. They love to deride its inefficiencies and problems, but as soon as anyone attempts to take an axe to it, it transmutes into the most valuable aspect of being British.

Of course, those of us involved with healthcare know that this is more than just an election issue. The changing demographics mean that the NHS, and every other health system in the world is heading for financial meltdown. Rather than acknowledge it, our politicians (even those who have been pushing through the U.S. Health reform bill) are doing little more than being fitted for their lemming suits and asking for directions to the edge of the cliff. We cannot afford healthcare in its present form and we’re running out of time to address that inconvenient truth.

One straw that is invariable grasped and brandished is the potential of mHealth (or eHealth, telecare or eCare) to sweep away the costs. So in the spirit of helping our flailing politicians, I thought it might be an opportune time to review how it’s doing.

British Gas – Smart Meters get real

Yesterday’s announcement by British Gas that they are about to deploy 2 million smart gas meters is probably the most important move that the smart energy market has seen. There are two things that make it significant.

The first is the fact that British Gas understands data. Back in 1995 they were the first corporation in the world to roll out GSM data connectivity to all of their service engineers. They’ve kept on quietly pushing the leading edge of technology ever since.

The second is that they are a major player in a market that has been deregulated for many years. They know that they need to persuade customers to stay with them and that those customers have a choice.

Both are skills that are markedly lacking in many of the other trials we have had around the world. If anyone can prove that smart metering will work it’s probably going to be British Gas. In a week where an Associated Press report poured scorn on the security of smart meters, and shortly after the PG&E billing fiasco, the industry needs some good, solid evidence of where smart metering really is. Compared to this deployment, everything else may look like rank amateurism. This will be the one to watch.

Electronic Health Records, Data Integrity, Consumer Apps and Continua.

A few weeks ago I was talking to someone who mentioned the Talisman SOS bracelet that she and her family wore and suggested that people should be encouraged to add basic medical information into their phone. In the UK there have been a number of campaigns to persuade people to add an ICE (In Case of Emergency) number into their list of contacts. Her suggestion was that this could be expanded to include key medical details. Plenty of such phone apps like this already exist, such as My Life Record, Smart-ICE, Hermes and Allscripts Remote. The problem they bring is how much they can be trusted, particularly in an emergency. It’s something that is causing considerable anguish not only within the medical profession, but also within industry groups who are trying to move medical monitoring into the home. It was a hot topic at this week’s Wireless Communications in Healthcare Conference in London.

At the heart of the problem is the integrity of data that goes into a clinical record. Until recently, data was only ever entered by members of the medical profession. The advent of accessible electronic health records means that patients can begin to enter their own data or modify their records. Whilst I believe that’s the way the world has got to move, it raises important issues.

Take the case of Julia…

Smart Energy & Strange Alliances

It’s been an odd month for Smart Energy, or at least for the wireless standards that are tackling connectivity around the home. If you were to go back six months, then, at least in the U.S., the general consensus would have been that ZigBee had the market tied up. It had the only profile with “Smart Energy” in its name and was winning the PR battle hands down.

Within the major working groups, things weren’t quite so clear. NIST, which has been trying to herd the wireless cats into some semblance of order started a more thorough analysis of just what existed, which saw an increased emphasis on other members of the IEEE 802 standards family, bolstering the fortunes of Wi-Fi (in its 802.11 incarnation) and Bluetooth (in its 802.15.1-2005 form). And it made its preferences clear about a need for IP support. But the status quo didn’t seem to shift very much as a result.

Then, last month, Bluetooth emerged from its normal mode of PR silence to announce the formation of a Smart Energy Study Group. The fact that Emerson, one of the world’s leading manufacturers of home HVAC devices was one of the sponsors for the group caused some noticeable shivers in the Smart Energy marketplace.

This week, there were more ripples, when Wi-Fi and ZigBee announced their Alliance of Alliances to jointly provide an in-home solution for Smart Energy. The Twitterati thought it significant, but what was behind it? Is it deadly rivals joining forces against a common enemy, or is there more going on?