Creative Connectivity

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.

Who stole my mobile broadband?

Earlier this month OFCOM – the UK’s regulatory body, published a set of maps showing coverage for the five UK networks with a 3G license. If you’re one of those people who believe the network’s claims about almost universal coverage, they will come as quite a shock. Rather than a ruddy red glow of national coverage, they make the operators look more akin to a teenager in the first flushes of acne.

They come as a worrying dose of reality given the promises of Lord Carter’s Digital Britain report. Whilst 3 can claim to have something approaching the start of coverage (and I’d stress that it’s only the start of coverage), the efforts of the other four, and in particular O2 is nothing less than shameful.

There are a couple of things that make this even more concerning. The first is that the results are essentially theoretical, based on an agreed propagation model; OFCOM has yet to validate them on a large scale by checking actual reception. The report mentions that where a comparison was made with test drive data it resulted in an 8dB correction, but they don’t mention in which direction, or whether it is reflected in the maps. The second concern is that this is presumably the coverage for voice. If we look at mobile data, we know two things: a much better link budget is required to achieve decent data rates as edge effects drastically limit the effective size of the cell when multiple handsets are using it (See my earlier post and Moray Rumney’s excellent article). If these are applied to the coverage maps, the prospect for national mobile broadband looks like a pipedream.

The question is whether publication of this data will shame the networks into improving their coverage.

Energy Harvesting – The lights may be going out for ZigBee…

Every farmer knows that if they want a good harvest they need to take care where they sow their seed. One of the first principles they’ll learn is to sow the seeds on their own land, not their neighbours. So I was somewhat shocked to see the recent announcement from the ZigBee Alliance about their new Energy Harvesting profile, dubbed ZigBee Green Power. In their press release they talk about a feature set to establish a global, standard technology for self-powered devices operating through energy harvesting techniques.

There’s nothing fundamentally wrong with that as a goal. Energy harvesting’s a fascinating area of technology, which has only recently emerged from research into reality, as better generating technology is devised, along with lower power radios. It’s taken around twenty five years to come to fruition, during which companies and researchers have been actively patenting their ideas and techniques. Those patents don’t just cover the energy harvesting devices, they cover all of the parts of the chain – generating the power, converting it to a form that can be used, storing it, connecting to a radio and transmitting information. They also cover the applications, such as wireless light switches.

Hence my amazement at the naivety of the ZigBee Green Power press release. Whether or not ZigBee can come up with a specification that is able to run on a few tens of microJoules of power is irrelevant – I’m sure they can as they’ve bright people working in the specification group. What is far more important is whether or not it will be legal for anyone to ship a device that is based on it, as it will almost certainly infringe the Intellectual Property of the main stakeholders. So the press release looks like either an ill thought out, opportunistic attempt to regain some momentum, or a worrying piece of evidence that the ZigBee Alliance has lost the plot…

Where’s the Apps Store on the wired Internet?

Everyone in the mobile industry wants to emulate Apple’s success with their Apps Store by having one of their own. They also want to believe that they’re offering mobile Internet. But if they were to spend just a few moments looking around they might question the sanity of either view.

There’s no doubt about the success of the Apps store. Customers with iPhones appear to be deliriously happy to pay to put shortcut icons onto their phones. But does it make sense? Or is the industry just repeating the self delusion it first perpetrated when it declared that WAP was mobile Internet?

There are some fundamental differences between mobile and wired internet, not least of which is, if the Apps Store concept is so good, why doesn’t it exist on the wired internet? Could it be because the mobile and wired internet really aren’t the same thing? The mobile industry does not want to talk about that, as it undermines the whole concept of the mobile internet. So let’s talk about it…

Peer-to-peer vs Femtocells. Let the topology war begin.

Two of the new wireless technologies that have come to the fore this year are high speed peer to peer connectivity and femtocells. Although they may not appear to have any obvious connection, I would argue that they do. Moreover that connection is so strong that they will end up fighting a technology war between themselves for a key customer application. That’s because they both have a major impact on the way that users transfer data between their personal devices. Today these two technologies are barely aware of each other – they’re both too busy gazing at their respective technical navels and ignoring the user requirements. Within twelve months, when they understand the real use cases they’re enabling, they may well be at each other’s throats.

Continua Health Alliance takes the bigamous route – Bluetooth and ZigBee.

After months of debate, the Continua Health Alliance finally announced its choice of wireless technology for low power medical devices. Bluetooth low energy and ZigBee have been the key antagonists in this process and today Continua decided to make it a threesome and share its bed with both partners.

Both brides proudly announced the forthcoming nuptials, Bluetooth claiming that it had been chosen as the Health Device Standard, and ZigBee pronouncing that it has been selected for the next generation standard.

Whilst most people outside the specification groups will dismiss this as irrelevant, it does have some important implications, as it presents medical device manufacturers with a dilemma – which of these two wireless standards do they choose? We’re at a point in time where we’re about to witness a new phenomenon of internet connected, consumer medical devices, which will open up the possibility of a new era of personal healthcare. If manufacturers become confused about which of two incompatible standards to use, they’ll delay their products, with a resulting delay in availability and implementation. It’s important that doesn’t happen.