Month: June 2014

Vessyl – You are what you drink

Once in a while you see a new technology that looks amazing or as the late Steve Jobs used to love saying ‘magical’. I have seen nothing like this before and for me it will be genuinely useful. I like to keep a track on my hydration as part of my fitness ( a struggle ) and I am sure a few too many calories are sneaking in my diet via uber-coffees ( although I am moving more to simple black Americano now ) and fruit juices and so on. How many calories are you and I getting via alcohol as well?

Watch the promo below:

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CE logo

Who is watching the iWatchers?

One of the issues I have mentioned in previous posts is the reliability of the data generated by wearables. At the Gadget Show Live in Birmingham last year I had an interesting chat with the representatives from a health product company. I was curious about its accuracy and I mentioned I was a doctor. “Oh no, this is not approved for medical use” she interjected. The reason for this came out was that it was too expensive for medical certification in their country.

This was something that has stuck with me ever since when I see new wearable technology. The question is simply this – what’s to say that shiny bit of tech on your wrist isn’t completely making it up? Who is checking on the reliability of this data?

To look into this more I researched which government agency in the UK regulates medical devices. This was easy as the Medicines and Healthcare Products Regulatory Agency ( from now referred to as MHRA ) often send warnings to doctors from time to time to warn about faulty devices and more. The MHRA considers these devices that collect data but do not offer advice or treatment based on the data provided as ‘borderline medical devices’. Think about it for a moment and its evident all the current smart devices simply feed you metrics about yourself. They do not interpret it for you in any way or give advice. If they did they would fall outside of this group and be classed as medical devices and be subject to much stricter and expensive regulation.

The MHRA bases its guidance on a piece of European legislation called the Medical Devices Directive ( in particular Annex IV,V and VI if you are interested ). Devices that meet the criteria of the MDD can label their product as being CE certified. It looks like this:

CE logoSo now we know what that logo means on our gizmos! What comfort does this afford us then? Does it mean its had to go through tests to be shown to meet certain standards?

No. Sadly it doesn’t. The CE mark is entirely voluntary and is “a manufacturers self declaration that it meets the standards laid out in the MDD” ( stay with me folks ) and that “it is fit for its stated intended purpose”. Now to be fair it does state “where required” the device applying for CE accreditation may need assessment.

I don’t know how you feel after reading that but it didn’t exactly inspire me with confidence for the safety and accuracy of devices carrying this mark. I read “we promise that it won’t blow up on your wrist and amputate your hand and honestly it does sort of count your steps/heart rate/breathing”.

So where does this leave us? As a doctor I know that I will of course give a little credence to the patient who presents me with some data that is alarming them but equally I know that there is no way I can trust this data given that it hasn’t undergone independent verification for accuracy and calibration.

I reached out to NHS Media to see what they are doing to deal with this coming data onslaught and regulation issues it raises but as yet I have had no response.

If you know more about this or have insights as to how this works outside the EU I would love to hear from you!

Apple creates Health app

Apple have announced their new Health app and Health Kit for developers at this years WWDC ( World Wide Developers Conference ). It is set to help us all make sense of the data from our various devices and be able to look at our stats in one place.

It looks a typical clean interface and easy to use as would be expected from Apple but with more system wide changes in iOS8 we may see more interesting uses of the data. For example thanks to something called ‘Extensions’ apps will be able to share data between themselves in ways never before possible on iOS. Should you be fortunate enough to have a forward thinking healthcare provider you will be able to share your health data with your doctor straight from your app.

Doctors are going to need training and their own software to help them make sense of this potential deluge of data. We have never been trained in how to interpret so many data points from an individual and the whole issue of how much credibility to give this data is a whole other subject in itself. Also its all good and well to say “share this with your doctor” but how much of a doctors time is this going to take up?

I don’t pretend to have the answers but unless this is given some thought it could end up in mess with data flying in to doctors which they have neither the time, confidence nor skills to deal with. I think that would be a terrible shame as tools like the Health app will hopefully make people more engaged with their body and give them the feedback they need to promote healthier living. Also if privacy issues can be ironed out and be clear, anonymous data from millions of individuals could help redefine our understanding of the human body.

Apple’s announcement is very exciting and it will come as no surprise if they release their own health device later this year which may have features that work more smoothly than third party devices.

Your move Google…

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