Personal fitness featured high in the range of proposals, as illustrated in those from finalists Lisa Durlam and Patrick Coulbourne.  Lisa and her team at Swimovate have come up with a Bluetooth enabled watch for swimmers.  Accelerometers within the watch monitor the swimmer’s movement, and from that calculates their speed, number of strokes, calories burned and distance swum during each session.  At the end of the swim, it connects to the swimmer’s mobile phone an uploads the data to the internet.

 Patrick doesn’t like his water wet - he prefers it in its frozen form and has been applying Bluetooth low energy to a range of interactive snowsport equipment.  His company - Flare Snowsport, has made an innovative use of Bluetooth low energy’s advertising capabilities to send geo-positional information, along with trail information as skiers pass by.  The information is captured by a personal clip worn by the skier, which can also capture information from a heart rate, temperature and blood pressure monitor.  At the end of the day, the skier can upload the data to their personal website.

 Moving away from sports, Michael Kohler of Edumotion made the finals with a fertility monitoring device.  The miniature device uses a thermopile to measure a women’s core body temperature, sending the data to be analysed to predict her optimal time for conception.  Such a device needs to be small and lightweight if it is to be comfortable to wear and unobtrusive.  The high level of integration in Bluetooth low energy chips means that personal sensors can be made that are not significantly larger than the coin cell that powers them.

But the ultimate winner was Edward Sazanov of Physical Activity Innovations.  His Fit Companion clips to your shoes and monitors your movement during the day.  It’s bright enough to recognise your posture, as well as whether you’re moving and how fast.  It sends the data to an application on your phone, prompting you whenever it thinks you’re, it moves beyond veering into couch potato territory.  By looking at overall behaviour it move significantly beyond current devices like pedometers to give a broader view of a user’s lifestyle.

This year’s awards were part of an ongoing competition.  If you’ve got a good idea, log onto the participation website and tell the Bluetooth SIG how you can change the world.

The organisers probably weren’t expecting snow, but it didn’t stop the audience turning up en masse to Mobile Monday’s mHealth meeting in Amsterdam last week. The presentations were far from chilling;  mHealth is moving from a position of  relative obscurity a year ago, to something that every network operator feels they need to have.  Vodafone, AT&T and Telefonica have already declared that it’s a key part of their strategy.  The potentially still-born US health reform and accompanying monetary stimulus plans have convinced many more that there’s money to be made from it, and 400 plus attendees were keen to understand where those opportunities may be.

There’s nothing like a church for evangelising, and Mobile Monday had provided the ideal venue in the form of de Duif - a splendid former church on the Prinsengracht in central Amsterdam.  It’s the first conference I’ve ever spoken out that had a live organ to regale the delegates as they came in.  It brought a very civilised touch to the proceedings that others would do well to emulate.

The aim of the conference was to explain what mHealth is, look at what it can do and investigate some of the business models.  First up was Bart Collet of Zogbeheer.com.  Bart runs a care home and writes software to help in the management of such homes.  That makes him a good spokesman for this industry, with practical experience both of developing and using the technology.  Bart set the scene, by examining the five key challenges for healthcare: 

• the increasing size of an aging population,
• the associated increase of chronic diseases,
• a shortage of funds, along with a shortage of medically skilled personnel,
• a change in patient expectations of healthcare, and
• the barrier of rules and regulations.

Bart gave some stats that indicated that 98% of the aging population do not want to move to a care home (I wonder about the 2% that do).  To achieve that we have to take the route of monitoring people at home.  That means more and better deployment of monitoring equipment.  The good news is that the hardware should not be a problem, as small, inexpensive sensors are becoming available.  The anticipated cost savings are estimated to be 64 billion euros in Europe. 

mHealth is already saving money, even using simple services.  I’d argue that it’s only the simple, process based ones that are saving money, but we’ll come to that later.  The classic mHealth cost saving that are always trotted out is the example of using SMS for appointment reminders.  In the UK, no-shows cost the NHS 645 million euros every year.  Simple text reminders have reduced that by 27%. 

Staffing is a more intractable problem.  In most of Europe we have staff shortages, and we don’t have time to train new staff.  Keeping patients out of the medical system should help, but I’m sceptical that this will arrive in time.  And as we get more technology and change, politicians will probably slow deployment by giving us more regulations

Moving to trends, Bart enthused about the use of cellular modems in medical devices, creating great opportunities for mobile operators.  Allegedly 19% of users would upgrade their mobile plans to engage in mobile health, or change provider if they thought it would help.  Hence the rush to the watering hole.  I have more time for that argument, but there are immense barriers to make it compelling.  There are plenty of commentators who look to third world take-up, and suggest that the third world will export eHealth business models to us. Again, I’m less than convinced.

There’s no doubt that fitness and wellness apps will overtake medical ones.  Vital signs are already being monitored, and the line between health and fitness is blurring.  Bart envisages that we will move to the point where the body itself is the ultimate point of care.  It’s a world where we will wear sensors that monitor every moment of our existence.  That’s a message that comes from an observation of the ludicrous speed of sensor development.  The difficulty is in believing that anyone will do anything with that overwhelming quantity of data.  It sounds worryingly like some science fiction storylines, where a population has come to accept a supposedly benevolent medico-dictatorship.

Following on from Bart, I felt the need to play Devil’s advocate and question whether the belief that the world is even ready for mHealth .  I think that the technology side of personal monitoring will get solved in the coming few years, as the new Bluetooth low energy standard makes it cheap and easy to manufacture sensors that push our personal data to the web via our mobile phones.  That’s the easy bit.  The difficult bit is in persuading anyone to wear the sensors.

I disagree with the easy pitches that mHealth will save us money, or that any large constituency actually wants it.  In the long term it may save money, particularly if it helps to establish a broader database for evidence based medicine.  But that’s a long way in the future.  The fundamental fact that no-one dares speak, is that we’ll only make a major dent in health costs when we get rid of half of the current medical staff, as it’s salaries that take up much of the spending.  I don’t know any government minister that would publically say that.  And as more parents push their kids into medical school in the hope of a career that pays the mortgage and gets the pension, things are only going to get worse.  It’s like building more roads.  They just encourage more people to drive.

Meanwhile, the general medical profession is less than keen on mHealth.  Whilst a few may embrace it, for most it threatens their professional status and careers.  Nor do most patients want it.  The sad fact is that most people like to ignore their health until it goes wrong.  Which is why we have an increasing issue of obesity and similar illnesses. 

The corollary from that is that we need to find solutions to easy problems that we can persuade people to use.  To get the debate going I threw up four possible business plans:

• Engage the open source community and patient groups to design their own applications for those with long term chronic conditions.  I call that model “the Wisdom of Sick Crowds.”.
• Target the guilty, selling dieting plans or similar,
• Don’t forget alternative medicine.  There no reason that mHomeopathy shouldn’t be just as profitable as mHealth (although I hope it’s not.)  However, alternative medicine has fewer barriers than traditional healthcare and may well innovate faster.  In the same way that the porn industry drove internet development, alternative medicine may drive mHealth.
• Use personal monitoring to sell generic (and alternative) drugs directly to the patient.  On average, we digest around 54,000 pills each over our lifetime.  It’s got to make commercial sense to find a better way of prescribing and dispensing them.

And if all else fails, don’t forget to look at schemes that monitor your kids and pets.  A copy of the slide set is available here.

Bringing us back to reality, Jeana Frost talked about her experience with Patients like me.  The medical experience that most people have is very much a top down one, Companies like Patients like me are trying to change that.  Jeana recalled how, as a student, she had been influenced by discovering that patients become more involved with the healthcare decisions when they were able to take a greater part in the treatment process.  Patients like me has taken that into reality.  It allows patients to enter their data, which is then aggregated, allowing groups to see how others live with the same disease.  Today they have over 50,000 patients in 9 different condition groups.  They’re working on how to provide meaning out of the information they aggregate, particularly in the form of mood charts, which members can use to compare themselves with each other,  it’s an interesting take on feedback and a good example of where mHealth data manipulation needs to go.

The community is also proving useful for researching treatments.  Patients find it useul in learning about their symptoms; from there, improving the way they record them and in turn reporting them to their doctor.  In a warning shot to the pharmaceutical industry, the database is beginning to bring up a range of side effects and reactions to drugs that can be sharply at variance to those reported in clinical trials.  That’s because it’s coming from patients that have become comfortable with their conditions and have started to describe them honestly as a part of their life.  It’s another sign of how mHealth could dramatically increase the evidence base behind modern pharmacology.

Robert Houtenbos, from Dutch insurer Univé-VGZ-IZA-Trias provided an overview of mHealth in Holland, and the issues faced in trying to attain the Holy Grail of mHealth.  From an insurer’s viewpoint, everything must be based on trust - their business model is predicated in a trusted relationship between insurer, patient and doctor.  To move forward, he believes that they need to open up APIs, so that multiple sources can share information.  It means changing their perception from Big Brother to Big Sister (although what she’d place in Room 101 wasn’t explained).

It’s not just about technology.  3G doctor is a service that lets patients use their phones to have a video consultation with a doctor.  It might be 3G, but it’s not about technology - the phone is just the vehicle in your pocket.  The core concept is simple.  But, as Dave Doherty explained, the reality of delivering the service is very different.  In order to be able to launch the solution, it required every segment of the medical profession to be convinced that the patient is not compromised.  They needed to persuade the authorities that data would not be lost, that patient’s records would be continuous and integrated and that the information offered met professional requirements.

It illustrated the issues (and benefits) of working within the system.  It took prodigious effort for the medical profession to accept it.  As a sideline, 3G doctor also offer vast amounts of reference materials to doctors via their phones, which the doctors love, as it reinforces their status as knowledgeable Gods.  So having got there, it’s win-win.  It’s a good example of how mHealth can work when you scratch the back of the medical profession, and hence a perfectly valid business model.  But I’m not convinced that it’s the sledgehammer that we need to change the current way we deliver healthcare.  For that we need something far more disruptive.

That only took us to the break. The presentations should available soon on the Mobile Monday site. Next week, I’ll cover the second half…

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.

When a company designs a medical product they quite rightly need to take it through a range of qualifications and certifications to ensure that it works and does no harm.  The newer and more innovative that product is, the more important that is.  But the level of these tests is getting onerous.

For any electronic products there’s CE or FCC requirements to make sure it meets basic safety levels.  If it includes a wireless connection, like Bluetooth or Wi-Fi, it needs to pass the qualification requirements set by those bodies, plus additional RF testing.  Most designers of medical products are now using the Continua Alliance guidelines, which mean that products from different manufacturers will provide compatible data.  That’s another certification and another cost.  To sell it in the U.S.A. it needs to be certified by the FDA.  Which is a considerable additional cost.  In fact we’re reaching the point where these costs can come close to the cost of designing the product.  Guess who pays?  In one form or another, the consumer.   And now the Senate has slapped on a device tax of 2.5% to every product to help make it less affordable to those who need it most.

But the more worrying feature of the bill is the proposal to institute a national registry of medical devices.  This seeks to list the serial number of every product that is sold.  The rationale is that it allows more effective recall of faulty products.  But it has the prospect of creating a bureaucratic monster that could potentially try to track every download of every iPhone medical application.

The recently published white paper form Triple Tree raises the spectre of the damage that the FDA could do, asking “If an iPod includes an application for diabetes tracking or another medical use, does Apple need FDA approval before selling an iPod?”  According to the letter of the law, the answer is yes.  Today’s bill potentially grants it even more draconian powers.

I’ve previously highlighted this issue and argued that we need the FDA and other regulators to step backwards.  There is no question that critical and new products need to be checked and regulated.  But if we want to encourage innovation, then we need to decide which categories of medical devices can be exempted to allow users to innovate.  I’ve suggested that Consumer Healthcare needs its own Manifesto to free it from the embrace of unnecessary regulation.  After today, that seems even more important, but sadly, further away than ever.

Today the device tax only applies to the more clinically focussed Type II and Type III FDA devices.  But taxes like this have a nasty habit of spreading.  As soon as personal healthcare takes off in volume, there’s a real risk that tax hungy legislators will see that as another source of income.  That’s a slide which must be resisited.

Despite all of its headline appeal, it feels that the details of today’s bill don’t understand the needs of the consumer.  Whilst welcoming the number of those it brings into healthcare, I’m worried that it will do nothing to help tens of millions more take more control over their own health.

It’s not a new message, albeit it has been revitalised by the prospect of the Obama billions.  The physicians believe that they can heal themselves, or at least the system they work in.  So it came as a breath of fresh air to see a posting that popped into my inbox from Joe Macaluso on Real Health Reform.  It argues that the only way we will see any real reform is if it’s done by patients, without the support of Congress or the medical industry.

Over in Europe, the EU is running a debate on Consumers and Health, asking for contributions to a seminar in Brussels at the end of the month.  I’d been thinking about this for some time and had come to the conclusion that the most useful thing that the EU commission could do would be to look at how to change the regulatory playing field.  That’s necessary to let patient-based groups start to take healthcare and even prescribing into their own hands.  To achieve that I think we need a Manifesto for Consumer Health, that provides a safe environment for disruptive developments.  By coincidence I’d just finished writing my thoughts on that, which I was posting to the EU Consumers and Health site as Joe’s mail came in.  After reading Joe’s post, I’ve added a poll asking “Whether you believe that healthcare reform needs to be driven by patients, rather than medics or legislators?”  Please go and vote - I’ll post the result in a later blog.

So why do I think we need a manifesto..? 

Over the last decade we have heard proposal after proposal to “solve” the demographic problems that increasingly challenge our health systems.  Billions of dollars and Euros have been poured into research that only ever appears to act as a basis for yet another research project.  As a result, rather than containing the cost of healthcare and improving patient expectations, the health industry continues to roll along largely unchanged.  Everyone continues to point out that the health system we have is broken.  But it is happy to remain so, as long as it makes money for all involved.               

A major reason for that is that governments persist in asking the health industry to reform itself.  They persist in believing in the old maxim of “physician heal thyself”.  All of the evidence is that whilst they are making a comfortable living, they have little incentive for fundamental change.  Instead their comprehensive hold on the health system serves as a barrier to stifle the more disruptive patient led initiatives.

If we are to take cost out of healthcare, there is a fundamental corollary - we need to take expensive medical staff out of our future health system.  eHealth or Telecare solutions will not offer savings if we still need the same number of health professionals to deliver our healthcare.  Instead we need to look at ways in which patients can self-manage their health, using the medical profession only when they need major medical intervention.  

That is why I believe we need a Manifesto for Consumer Healthcare and Wellness.  Today the system and regulatory procedures throughout European member states work against patient groups developing their own care structures.  Instead they support the maintenance of the status quo.  We are about to see the emergence of a new generation of low cost, connected medical monitors, such as weighing scales, blood pressure meters, blood glucose meters and pulse oximeters.  These will let patients measure their own health trends, often using the convenience of their mobile phones to transmit data, and save them to their own personal health records.  It opens up the ability for patients to begin to measure their own wellness and trends. 

If we are to persuade our citizens to embrace these developments and begin to use them for society’s mutual benefit, they need to have compelling reasons to do so.  All of the evidence suggests that this will not come from medical companies or state health systems - they are too set in their ways.  Rather, we need to encourage new, disruptive approaches that address their own quality of life.  Already we are seeing the growth of special interest groups of patients who share information on their diseases.  That’s eminently sensible, as they have the hour by hour experience of living with their chronic conditions.  They know what influences their daily life and how best to manage it.  This is where change and compelling applications are likely to come from.

As low cost diagnostic monitors become available, the next step is for these groups to work out how to share their data, and the way they manage their disease, working towards medication or lifestyle regimes that give them the best possible quality of life.  From that, the obvious progression is to give them access to prescribe their own medication, independently of the current gatekeepers.

This will be resisted by the current medical hierarchy.  Whilst there are valid arguments for continued regulation to preventing damage and charlatanism, they need to be modified to encourage innovation.  As vested interests will attempt to deny this progress, we need an EU wide approach to enable a disruptive approach by providing a framework that removes barriers at the same time as trying to include appropriate patient safeguards.

To enable innovation to happen as quickly as possible, it is important to provide a environment that is conducive for development.  That needs guidelines and possible support to let patient based groups pursue models which the established medical establishment may see as disruptive or threatening.   For that reason I propose that the EU implements a Manifesto to enable an atmosphere which allows patients to build these new structures.

There are other benefits from this approach.  The development of these groups and self regulated measurement of patient conditions provide a unique opportunity to build a database of evidence for different treatment plans.  Encouraging open source development of such databases could provide a more valuable source of evidence based treatment than anything that has come from previous medical trials.  It may even be able to use this to feed back into the conventional medical system.

Manifesto for Consumer Health and Wellness

The EU should work to provide an environment to stimulate the development of patient centric healthcare initiatives.  This concentrates on removing restrictive barriers and providing a framework for a radically new approach for healthcare development, led by patients.  It should help to protect such groups from regulatory discrimination, encourage innovation, communication and dissemination of information and provide access to sources of appropriate medication.

Key points are:

• Encourage patient based development
• Remove regulatory barriers to group self-treatment
• Review prescribing barriers, allowing groups to work directly with pharmaceutical suppliers.  This may need to be limited to a defined list of generics, and be dependent on the open availability of anonymised patient data.
• Encourage and share best practice in the development of “trust” strategies for patient groups
• Provide a directory of innovation and promote the most compelling applications.
• Provide a forum for dissemination of data
• Optionally provide an EU personal health data storage facility, based on open source standards, for use by patient groups.
• Extend wellness and personal health from the personal group to occupational health, without the need for traditional medical involvement.

That’s just a starting point.  It’s a debate that we need to start now, so that those who start to develop new applications can concentrate in innovation and not fighting regulation.  If you’ve any other suggestions, please let me know.

Scotland is an interesting country in terms of health, as it contains a number of anomalies.  At one end of the spectrum it boasts some of the best examples of Telecare and Assisted Living practice anywhere in the world.  In the middle are some excellent preventative initiatives.  And at the other end it has issues with lifestyle and diet that are propelling its population towards an increasingly unhealthy future

The issue of diet is a long-standing one that starts at an early age.  Whereas England is embracing chefs like Jamie Oliver who are leading high profile campaigns to improve the quality of school meals, Scotland largely ignores them.  If you’re in Scotland at lunch time, you’ll see queues of school kids outside the local chippies and bakers downing their daily intake of carbohydrates as they start on the route to weight related health problems.  For most, lunchtime means a trip to the local obesiary, which is typically Greggs - the chain of bakers who feed a large percentage of the population. 

Festival time and the influx of non-Scots appetites don’t have a noticeable effect on the traditional catering preferences.  When you’re eating in Edinburgh, it’s Chips with everything (which was sadly not being performed this year).  Try and order something without chips and you’ll be met with a stare of incredulity.  Even if they take the order, the chance is that your plate will still arrive with at least half of its surface concealed with a pile of deep fried potato.

What I hadn’t noticed before was an observation made by Marcus Brigstocke during his excellent rumination on his God shaped hole, which is that the local Fish and Chip shop (chippy) next to the flat he was living in also sold Rennies.  I don’t know whether Rennies are an international brand, but for those unfamiliar with them, they’re the UK’s best known indigestion remedy.  There’s a rather inevitable irony abut the coupling.  Instead of reducing their portion sizes, the local fast food takeaways take the approach of selling you the next product you’ll need.  It was an observation that started me looking at each chippy I passed and sure enough, each one had a shelf of indigestion tablets.  The obvious next step would be for them to start selling blood glucose test strips as well, but I didn’t manage to spot any that had made that connection.

More detail on the intricacies and etiquette of this most essential part of the Scots food chain came in a wonderful little event at the West Port Book festival.  Peter Burnett has devoted a year of his life to listing everything he has eaten and published it along with comments in The Supper Book, which I would recommend to anyone studying the Scots diet.  (Or anyone interested in the trivia of food, such as the fact that the inventor of the Pringles tube left instructions for his ashes to be buried in one.)  The chapter on chippies enlightens us further with another strange Scots custom.  If you order a single fish it will result in your being served two.  It also explains that Supper is an adjective that ensures you have chips with everything.  For those with more exotic tastes, that extends to the Deep Fried battered pineapple supper.

At the extreme end of the carbohydrate spectrum, Scotland is the home of the deep fried Mars bar, that pinnacle of calorie laden culinary excellence.  It’s become such an emblem of the Scots lifestyle, that you’ll see chippies with standardised adverts for it.  Which is more than you’ll see for the better known, but possible less eaten speciality - haggis.  By coincidence, at the same time as the Festival, a meeting of the Royal Society of Chemistry in Glasgow was being presented with a paper by Georgina Rayner who had performed an analysis of the this quintessentially Scottish fare.  Packing a coronary inducing 600 calories, it apparently provides a combination of the major food groups we need in our diet, containing carbohydrates, protein and fats.  The only thing lacking is salt.  So for anyone on a low salt diet, head down to your local chippy for a healthy deep fried mars bar.

During the last few weeks the local papers have been bemoaning the increase in obesity in the Scots population, including a report that personal perception of size is lessening, making it easier for people to eat without worrying about how they look.  A few pages further on in the Business section, the same paper was happily reporting the growth in Greggs’ profits, with the prospect of them opening further shops.  At a recent healthcare conference when the panel I was sitting on was asked “what would be the one thing you’d suggest to improve Scotland’s health?” I glibly answered “Ban under eighteens from Greggs”.  After a few weeks in Edinburgh I’m not sure that is such a bad idea. 

Scotland needs to find a better way to promote healthy eating.  On being presented with another pub meal replete with unwanted chips I may have one alternative answer - don’t eat them, play Jenga with them.  I’m not sure the cook appreciated the stack of chips being sent back to the kitchen, but it’s one small step for sanity in the land of the deep fried diet.

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.

 The FDA was set up to protect patients from unsafe or fraudulent medicine.  Most countries around the world have a similar regulatory organisation, but the size of the US and the scale of its medical industry mean that it’s by the far the most significant of these bodies.  It sets down the regulatory barriers that manufacturers and service providers need to be met before a product can be shipped in the U.S.  And its work is sufficiently well respected, that most other countries place similar requirements on medical products.

Few people are aware of the potential breadth of its powers.  As well as setting down strict guidelines for the performance and accuracy of medical monitors, its remit extends to medical systems.  It has the power to regulate an overall system that affects the treatment of patients, including medication regimes.  In terms of what it can control, or prohibit the sale of, it has the final say over any product that is advertised as enabling either of these situations.

Let’s look at what this means.  The simplest type of mHealth is notifying patients of their next appointment.  That doesn’t directly influence something we take, so it’s not covered by FDA requirements.  A number of phone companies already offer systems like this, including Vodafone.  But if the doctor were to call to remind the patient to take their medication each day, that could be considered as slipping inside the FDA’s remit. 

The FDA’s power to stop the shipment of products technically covers any product that is advertised as a part of a health service.  Hence the comment above that they could stop Apple shipping iPhones.  The Apple Apps Store currently list around 1,500 health applications, which include medical reminders.  If Apple were to mention any of these in its advertising or publicity, the FDA would probably be within its rights to ban the sale of the iPhone.

That’s an awesome level of power.  I don’t for one moment expect FDA inspectors to turn up at Apple Headquarters to serve an injunction, but it indicates how far the market has moved ahead of where anyone originally expected healthcare to go.  The Apps store is a clear indication of where mHealth is heading.  I believe that the introduction of Android, which can connect directly to consumer health devices, such as Bluetooth enabled medical products, will provide a platform that accelerates this kind of innovation.

It’s vitally important that the groups that are going to be involved in these innovations start to engage with the FDA and other regulatory bodies now.  When mHealth starts to happen, it will result in major changes in the balance of power within the medical profession.  By bringing power to the patient, its effect is likely to be as great as the introduction of the printing press was to society in the fifteenth century.  Elements within the existing medical ecosystem are going to lobby furiously to maintain the status quo.  That’s why it’s important to have the debate now, before vested interests come into play to inflame it.  If we don’t engage with the regulators now, mHealth is likely to become mired in legal challenges, particularly in the U.S., which would be tragic, as the U.S. economy and healthcare system needs mHealth more than any other country in the world.

Fortunately, there is a strong ray of sanity shining from the Continua Health Alliance.  Continua has brought together a wide range of players to produce interoperable standards for medical and health devices.  That’s been a major achievement in itself.  However, I think history will look back and see Continua’s greater achievement as galvanising a diverse range of industry partners to come together to talk about a common cause.  Continua includes experts from health providers, insurers, medical device manufacturers, technical standards groups and even a few far-sighted mobile operators, such as AT&T and O2/Telefonica.  They’ve formed a regulatory group, which is discussing these issues with the FDA and regulators around the world.

This is the approach that needs to happen if we’re going to see a smooth evolution and deployment of mHealth.  Putting out press releases and lobbying may win a short term chunk of Obama’s cash, but it ignores the important work that needs to take place on the foundations of mHealth.   We need regulation.  mHealth is the new wild West of personal medicine, which will inevitably attract its share of quacks and charlatans, and it is right that vulnerable patients are protected from these.  I’d urge any other organisation, like the CTIA to join the Continua alliance and enter a co-ordinated discussion with the FDA.  If they don’t we run a real risk of cavalier deployments that end up in legal test cases, which will end up slowing innovation and deployment.  That is not the best way to reform healthcare and empower patients.

The desire of the U.S. administration is a great opportunity to reform healthcare and empower patients.  It is vitally important that it is tackled responsibly and not just seen as a short term grab for government funds.

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.

At a top level, this decision seems clear - Bluetooth low energy will be used for PAN (Personal Area Devices) - the ones that we carry around with us.  And ZigBee will be used for LAN (Local Area Network) devices - the ones that tend to stay within a building, either a home or hospital.  Go back thirty years and that’s the same sort of differentiation that was applied to telephones.  We had fixed phones in our homes and a few people had walkie-talkies for when they were outside.  But today that differentiation has disappeared.

The same is going to be true for consumer medical devices.  Although they will start out as personal devices that we keep discreetly hidden in our bedrooms or bathrooms, very soon they will become mobile devices.  That’s already happening with sports and fitness devices, where there’s healthy market for pedometers and heart rate belts.  As we evolve through a few generations of products, they’ll become smaller, more discrete and less obtrusive in the way they measure us.  And that equates with more mobile and more personal.  It removes the distinction between PAN and WAN - they just become the things we carry.

 Which brings us back to the dilemma facing device manufacturers.  It’s vitally important that they don’t delay their development plans, but they need to decide which of the two technologies to go with.  My personal view is that Bluetooth will dominate.  There are some technical reasons for that, but the biggest one is not technical - it’s scale.  Bluetooth based medical devices will be able to connect to mobile phones, which exist in billions.  So a Bluetooth medical device already has something to connect to.  In contrast, only a few million ZigBee devices have been sold.  It means that a company making a ZigBee based medical device has the additional cost of providing a ZigBee adaptor that can plug into a PC or phone.  

Vince Holton, writing on the Incisor blog, thinks Bluetooth will dominate.  He quotes Mike Foley - executive director of the Bluetooth SIG, who, when asked to quantify it, said that on a scale of importance, it was (for him at least) “one step below the potential Microsoft Yahoo acquisition”.  I’m not sure that I know what that means, but it sounds convincing and ought to get the financial community interested.

 Bluetooth provides the scale that is the honeypot for applications.  There’s already a growing and enthusiasm community of application developers writing apps for mobile phone.  Look at the success of the Apple iPhone App Store.  That’s already featuring hundreds of medical and health applications.  The same developers will jump at the prospect of connecting to real monitoring devices.

We don’t yet really know how the personal health device market will evolve.  We’ll only discover that when devices exist and applications developers start to play with them.  It’s important that they see this decision as the starting pistol to develop devices and not as one that makes them sit and wait.

For more information on the consumer medical ecosystem that Bluetooth will enable, download the White Paper: Bluetooth Ecosystem for Health and Fitness .

It’s not just a story about successful technology.  The world needs to reform its healthcare systems to meet the challenges of diseases like diabetes and asthma and to cope with the changing population demographics.  I’ve written a report describing these challenges and how Bluetooth is addressing them.  It explains how Bluetooth is evolving from it current position of de facto medical wireless standard by working with the medical and mobile community to ensure it provides the solutions that the industry need to scale to the billions.

Bluetooth’s success hasn’t come by chance.  Bluetooth offers advantages that other wireless options, whether standard or proprietary, are not capable of providing.  Key amongst these are:

• Excellent resistance to interference
• Best in Class Security.
• Low Power operation
• A RANDZ license-free regime which gives manufacturers the confidence to use it without being sued.
• Low Cost.  Both as a result of the design of the specification and the economy of scale accruing from the production of billions of silicon chips by multiple vendors. 
• Security of supply from that same range of silicon vendors.
• Being the short range radio of choice in mobile phones.
• Support from a community of over 11,000 member companies.

Medical devices are still not perfect; they have an Achilles’ heel, which is that the manner in which data is formatted remains proprietary, so similar devices from different vendors cannot talk to the same application.  That is already changing.  Bluetooth has worked with the Continua Alliance and the IEEE 11073 Personal Health Devices group to bring its Health Device Profile to market.  Chosen as the wireless transport by the Continua Health Alliance, it is a first joint step to remove this proprietary barrier and bring interoperability to the medical market.

However, we are only looking at the tip of the healthcare iceberg.  The next, vital step in this market, which will change its scale by multiple orders of magnitude, will appear as we make health and fitness devices cheaper and connect them to the web using mobile phones.  Today over half of the world’s population owns a mobile phone, the majority of which include Bluetooth.  The next Bluetooth standard, known as Bluetooth low energy will enable a new generation of battery powered health and fitness devices to talk directly to web based applications.  Using a gateway technology, every new phone will be able to work with every Internet ready Bluetooth low energy device.  Using the power of the scale and customer reach of the mobile networks and handset manufacturers, Bluetooth low energy has the potential to bring health monitoring to the entire world.

It cannot come soon enough.  The demographics of the world’s population are changing.  Advances in hygiene and medicine have brought us longer life, but with it increasing years of ill-health and a growing incidence of long term chronic conditions.  The models on which we have built healthcare for the last few centuries cannot stand up to these pressures, which drain an ever greater part of our GDP every year.

To address these issues we need to harness technology to help people stay well, promoting a healthy, independent lifestyle.  Technology may not necessarily cure people - that may or may not prove to be economic or even possible for the growing number of long term chronic conditions that we collect.  But it can be used to inform and help the population to look after their own health, whether that is as an active teenager, parent, or grandparent.

Life and health is a continuous spectrum.  In our youth, it may involve information about the way we play and our social interactions.  As we grow and have children, it’s about staying fit to cope with the pressures of work, mortgage and family.  Getting older, more and more of us are contracting long term chronic diseases and we need to find the best way to manage them as part of our everyday lives.  And as we watch our grandchildren grow up, we need help to manage our surroundings, to help us live independently with peace of mind for ourselves and our families.

Bluetooth is key to making this possible because of its capabilities and, most importantly, because of its ubiquity.  The latest version of the standard can support complex medical sensors as well as simple detectors for assisted living which need to run for years on a single battery.  By making the connection to the internet simple, using the established ubiquity of mobile phones and the internet, it will also give developers, whether they are medics, researchers, or enthusiasts within disease support groups, the opportunity to write software and web applications that help us to stay healthier. 

Bluetooth provides the platform for the innovation we need in healthcare.  There is no other connectivity option that has the scale to let us progress from today’s deployments of a few thousand users to a global deployment of hundreds of millions.  It is the only route to universal, connected healthcare. 

It’s a shame that this reaction is still so prevalent.  Social networks and the Internet will never be a replacement for medical care, but they have the ability to play a much greater role in how we live and manage disease.  Everyone with an ounce of sense who has looked at the demographics knows that we cannot continue with the current model.  We shouldn’t be pouring scorn on social networking, we should be looking carefully to see how it can help our healthcare experience evolve.

It’s unfortunate that the medical media and those they represent seem to be lining up with the Luddite tendency of populist pundits who equate any form of social networking with teenage time wasting.  The Internet and Mobile Data are with us.  They will change the way that people share and use information.  We don’t yet know where that change will start, nor where it will end, but it’s probably going to be analogous to the changes that came with the progression from monastic scribes to printing.  Social networks give us the tools – it’s up to the users and communities, not the professions, to work out how to use them. 

A good example of the power of users to develop social networks is text messaging.  They found that they could turn a well hidden, engineering feature in the GSM mobile phone specification into a useful tool.  The networks – the professionals in this case, did their best to stop it happening, as they didn’t understand why anyone would want to use it.  They belatedly realised they could make money from it and reluctantly embraced it.  The resulting SMS service is a technology that has already saved millions of pounds for health services by doing something ss simple as sending patient reminders.  We may not be aware what the future developments and benefits may be, but to cultivate a mindset where tweeting equates to birdbrains and bebo appears indistinguishable to buboes is not going to be conducive to progress.

What is important is recognising that the new communication programs and tools that are being developed to enable these new social applications will enable groups of interested individuals to work together to come up with new ideas.  It’s a process that’s well described in Clay Shirky’s excellent book – Here Comes Everybody: The Power of Organizing Without Organizations.  To précis his argument:

“For the last hundred years big organisational tasks have been taken on by the state.  There has been a universal and unspoken supposition that people couldn’t self-assemble; the choice between markets and managed effort assumed that there was no third alternative.  Now there is.

Today’s electronic networks are enabling novel forms of collective action , enabling the creation of collaborative groups that are larger and more distributed than at any time in history.  The scope of work that can be done by non-institutional groups is a profound challenge to the status quo.”

And that’s why we shouldn’t dismiss initiatives like this.  We shouldn’t jump onto every bandwagon that comes along just because it’s new, but we shouldn’t close our minds to them just because they’re adopted by a different generation. 

It’s not just the UK that has this problem.  In the run-up to the Health 2.0 Conference in Boston this week, Bob Mayes - Senior Advisor on Health Information Technology Issues to AHRQ, warns of the danger of older doctors stifling innovation in the US Health grant system. 

It’s important that we don’t embrace this backward looking attitudes.  Our current model of healthcare needs to be challenged, because it is not sustainable.  The tools that are being developed within the social networking community may be one of best hopes we have for starting that reform.  Let us explore how best to use them, not dismiss them out of hand as a pre-judged waste of time.

That’s important for them, as it places them far more firmly on their individual country’s roadmap towards a broadband future.  In turn, that’s important to handset developers, who will see it as justification to include broadband related technologies and features.  And it’s important to manufacturers of connected consumer devices that will extend the broadband reach beyond the handset.  It gives further emphasis to Bluetooth’s claim to be the mainstream low power technology for low power healthcare devices.  The reason is simple - an expansion of handsets supporting mobile broadband will mean a bigger critical mass of Bluetooth gateways.  That’s a reality the Continua Health Alliance and health device designers needs to factor into their plans.

There are two important messages behind the political manoeuvring.  One is the desire of the mobile operators to be part of the broadband future.  The other is a realisation that they can start to be part of a mobile health solution that the world desperately needs.  Both are close to the heart of the GSM Association, which is supporting these moves.

Mobile Internet was an early aspiration of the mobile industry.  It started by shooting itself in the foot when it attempted to persuade users that WAP was an acceptable alternative to Internet Explorer on a PC.  Not surprisingly, users disagreed.  Since that debacle, the mobile operators have managed to claw back lost ground, but still feel that they are considered the poor cousin of wired broadband, despite the potential of current HSDPA and the future promise of LTE.  They’re aware that unless they can persuade a generally technically illiterate legislature that they have a part to play, then they will miss out on the investment and opportunities of the “access to all” approach which governments around the world are rolling out.  Hence their current ploy of increasing their profile at the premier meeting of world leaders.

There’s a growing acceptance that the world needs to do something about healthcare.  The GSMA development fund is already doing some admirable work in helping and promoting mHealth in countries such as Mexico and Pakistan.  Up until now, there’s been a reluctance in the “developed” world to embrace anything with the word “medical” in it, not least because it has the corporate lawyer tossing in their beds at night with bad dreams of litigation.  However, operators are beginning to see that there are many, many less critical health and wellness applications where they can act as a trusted service provider.  Trusted in the operator world equates to customer loyalty and ARPU, so mHealth is becoming a topic of interest once more.

One of the problems in deploying health and wellness applications is the need to have consumer health devices that will connect to a mobile phone and use then that to send user data back to a monitoring application.  At present it’s a fairly specialised market, although companies like Polar are making convincing plays in the sports arena.  To break through from specialised to mass market, it needs standards that are supported both by handsets and also by consumer health and wellness devices.

The Continua Health Alliance has been putting together a network of standards, drawing on the IEEE for standardised data formats and wired and wireless standards groups to define the connectivity over which the data is transported.  Their first choice of wireless standard is Bluetooth, which already exists in the majority of mobile phones and which is capable of transmitting significant amounts of data.

Now the hunt is on for a complementary wireless standard that can cope with very low power health devices, capable of running on coin cells for months or years.  We need that for applications such as assisted living products, or body worn sensors.  There are a number of potential candidates, all of which have levels of technical merit.  What is possibly even more important is which of these has something to talk to.  Bluetooth low energy is a new Bluetooth standard  that can tick all of the technical boxes, but which has an enormous advantage – it will be able to talk to the Bluetooth chips that will exist within the next generation of mobile phones.

The work of the GSM Association and their group of 24 operators will increase the recognition that mobile phones are going to play an important part in the global broadband future.  It will result in a critical mass of billions of broadband capable mobile phones (which will contain Bluetooth low energy technology).  That makes the technology decision for consumer healthcare product manufacturers – they are only going to want to produce devices that have something to connect to.  If they take any other approach they’re going to have to provide a wireless dongle with each of their products, making them uncompetitive compared to a Bluetooth one, where the phone gives the local connectivity for free. 

That ought to make the decision for the Continua Health Alliance.  Whatever anyone else thinks, the standard that we are going to end up with is the one that the top half dozen phone manufacturers include in their handsets.  Otherwise Continua runs the risk of looking like the Esperanto teacher trying to persuade the world they should give up English in favour of their private, invented language.