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:
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!