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…

Julia is fictional – a healthy twelve year old who I’ve made up to provide an example of the problem.  She’s coming up to her thirteenth birthday.  Last birthday, her parents gave her an iPhone which had a personal ICE medical record on it, which allows users to add and edit data.

Julia, like many kids, like vampires.  She’s just been sitting in her room watching a film where the Transylvanian locals are close to exterminating the last vampires.  To preserve their line, the last two vampires cunningly mutate their blood to the previously unknown AB- group, telling each other, as the stakes go through their hearts, that whenever two AB- parents have a child, then their first issue will be a vampire, preserving the species for ever.  (Don’t ask about the science – it’s Hollywood.)

Not surprisingly, Julia thinks this is rather neat, and that it would be cool to update the health record on her phone from Group “O” to Group “AB-“, so that she can show it to her friends at tomorrow’s party and tell them her first baby’s going to be a vampire.  Her application lets her do it.

Walking across the car park to her party, she’s knocked down.  An overstretched hospital believes the information that her distraught mother reads from her phone and forgets the basic pre-transfusion checks…

It’s a rather forced, extreme example, but it illustrates the dilemma of personal health records.  Once individuals can update their records, then the meaning of medical records change.  It’s a fundamental point, but one that tends to get lost.  Patients may do it for perfectly valid as well as more nefarious reasons.  They may want to make changes to affect their insurance, to claim malpractice, to effect a change in their medication, to make their doctor think they are complying more completely with their treatment plan, or simply because they can.  Moreover, the data that comes from connected devices may not be accurate, as it’s unlikely the average person would think about, or even understand the need for calibration.

What’s even less appreciated is that this is only the tip of the iceberg.  Today, it’s a miniscule portion of the population who put data into a health record, or even realise that they can.  That’s about to change.  Consumer medical devices with a wireless link have the ability to push a constant stream of patient measurements into their health records.  It will result in a flow of data that is many orders of magnitude mote than has ever been seen.  And these devices will be freely available in the local mall or internet shop.  How much of the data they generate will be trusted by the medical profession?

The anguish is not just confined to medics who need to act on and have access to medical records.  It’s also affecting groups like the Continua Health Alliance, who were formed to provide an answer to the problem of preserving the integrity of health record data in a connected world.  The core role of Continua is not always well understood.  It came into existence to open up and provide guidelines for the ecosystem of connected medical devices that was starting to appear.  Many people think that its key function is to ensure interoperability between devices from different manufacturers, but that’s just a consequence of what Continua is doing.  Its real job is ensuring the integrity of data as it flows from the measuring device to the ultimate electronic health record.

If we go back to the anxious medics consulting a health record, they need to know that information that has been entered automatically, from an electronic link, is as accurate and reliable as if it had been transcribed by a medical practitioner.  Whilst it might seem natural to think that would be the case, in the connected electronic world that’s not necessarily so.  Whenever a piece of data is sent over an electronic link, particularly if it’s wireless, it may get truncated, compressed or transformed.  If it is accepted by a PC or phone application on the way, it might be converted to different units, averaged, corrected or manipulated in some way.  By the time it has passed through a number of different stages to get to the final medical record, it may have undergone a set of “Chinese whispers“.

The goal of the Continua Health Alliance was to provide an assurance that where each stage of the process conformed to their guidelines, the received data would be unchanged from that produced by the piece of medical equipment.  The Continua logo meant that the path from medical device to medical record was assured.

That is still the bedrock of the Continua promise.  But since Continua was formed, the world of smartphones and apps stores has blossomed.  To trot out an overused cliché, it has changed the paradigm.  Next year, as Bluetooth low energy appears in mobile phones, which enables a mass market of connected health and fitness devices, we’ll see the current trickle turn into a flood. 

Consumer health devices aren’t just changing the volume of data, they’re also changing the way it’s used.  Application developers for smartphone apps are already appreciating this, as they discover that patients have very different display needs to the medic.

Almost every medical device you can buy today displays its results in scientific format, whether that’s blood pressure, temperature or glucose concentration.  They may mean something to many medics – digital displays go well with the white coat image.  But increasingly, consumers are looking for health applications that present results in a manner that relates to their lifestyle.  That may be trends, traffic lights or some other representation, where the original data may not be preserved in its virgin state.  To do that, data is manipulated, and the integrity, precision or accuracy of the original data may be lost.  That doesn’t make this any less valid a health record.  It can be argued, that as it means more to the patient, it’s a better one.  But the question is whether it has the same level of integrity if a medical decision is going to be based on it?

In the coming year, the proliferation of low cost, wirelessly connected, consumer health devices will transform this market.  Much of the data they measure will only ever get as far as a mobile phone, although in time it may get uploaded to patient community sites.  It will generate an explosion in the quantity of patient data that dwarfs anything that exists today.  That makes it a powerful tool for driving evidence based healthcare forwards, if it can be aggregated and mined.

But it may not be, nor need to be accurate. That’s a concept that is very scary to many in the medical profession and medical device industry.

The industry needs to tackle the question of what to how to address this new world, where data may be qualitative rather than quantitative.  It is without doubt a valuable resource, but it is unlikely to sit comfortably in the current medical record mindset.  Continua’s view of end-to-end integrity assured medical record data remains unchanged, but how it will encompass consumer health peripherals for mobile phones.  They have the difficult question of deciding what their logo means on a consumer medical device or application.  Does it imply the gold standard of end-to-end integrity, or a device that connects to any consumer medical application?  Or both?  

The health record keepers within our medical systems face a different question.  They need to consider how to access the value of patient records that may not be derived with the same rigour as they are used to, but which will provide a new order of magnitude of patient data that can help better understand how to manage long term chronic conditions.  It will also be invaluable in driving evidence based medical treatments for them.

Many say the Internet changed the relationship and balance of power between patient and doctor.  That will be insignificant to the change that is coming over the next few years, when patients are able to measure themselves.