Wearable tech and regulation: Should fitness trackers face the FDA?

We trust them with our health data but wearables face calls for extra checks
​Should wearables be regulated?

Your wearable can give you almost any kind of health and fitness advice it likes, whether it knows what it's talking about or not. So long as our sports watches, fitness trackers, brain trainers, sleep monitors and the rest don't actually make any claims to diagnose illness or treat injury, then they are not considered medical devices. And that means they can tell us anything without the need of any certification.

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But should wearables that monitor our heart rate, brain activity or even steps be subject to government regulation?

Foetal heart monitoring could be an absolute disaster

The UK Government's Medicines & Healthcare products Regulatory Agency (MHRA) – which is essentially the same as the FDA in the States – is the body in charge of making sure that all drugs and associated healthcare products available on the UK market reach certain standards of safety. They're checked, they're standard tested and, ultimately, okayed but to fall under the MHRA's remit in the first place, these products need to meet certain conditions.

Implantables are considered medical devices as, indeed, are apps that claim to diagnose, treat, prevent or monitor disease and injury. Plus anything that's involved in the control of conception is covered too. But, sports and other wellness kit get away with it because, currently, they only need regulation if they happen to be designed for the gym to specifically measure heart rate and other biometrics as opposed to, say, repetitions.

There doesn't need to be any kind of qualified trainer or physician behind the algorithms that tell a person of 43 years of age, 183cm tall and 13 stone around their waist that it's time to get fit. And to do that you need to raise your BPM to initiate a physiologic change in fitness. But if that person keels over clutching their chest in the process, well, as far as the tracking wearable is concerned, that's too bad.

Unkeen to regulate

By our count, the only wearable covered by the MHRA regulations at the time of writing is Athos which might explain why it's only available to buy in dollars given that the MHRA's equivalent in the States, the FDA, seems even less keen to make new wearables jump through hoops.

In the UK, there's also the slightly stickier situation of whose remit wearables are exactly. While it appears to be the kind of thing covered by the MHRA, it's primarily medicines and healthcare with which they are concerned. For the time being, according to Harry Quilter-Pinner, analyst at UK thinktank IPPR, there's something of a wearables gap in legislation - one that no one is looking to fill.

"No one has taken it upon themselves to put wearables under their mandate and the Government hasn't asked anyone to do this," he began. "But, perhaps the most important reason that there's no regulations at the moment is that it's really, really hard to test how effective and what the risks of these actually products are.

"It's not like a drug where you can do a double blind test as easily and measure the direct impacts. That makes it very difficult and costly and, unlike drugs, the companies behind wearables are not going to foot that bill.

"Talk to the wearable industry and they'll tell you that they don't even want some kind of certification either because there's no funding mandate at the end of it and because it's not respected by any healthcare professionals. So, it doesn't make a difference to their sales or their ability to sell products."

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Perhaps, then, the only way to make this viable would be to bring in a regulation beyond that of MHRA who require a medical device to be stamped with a CE trademark which simply states that it meets European safety standards. The answer might lie in getting those aforementioned healthcare professionals to trust, understand and ultimately prescribe certain gold-standard wearables. That way, yes, the regulation process might be slightly expensive and tedious but, well, if you can get your Fitbit or Beddit bought up in bulk by a health service, then maybe that's worth a few quid?

Who takes responsibility?

Sadly, there's a rather large fly in the ointment in the shape of the medical industry's traditional adversary, the law. Even if certain approved wearables were trusted enough for your doctor to prescribe one, there is a secondary issue of accountability when things don't go according to plan, as Quilter-Pinner described.

Who is responsible if something goes wrong?

"What happens if the device is linked to your doctor but the doctor isn't watching or you make a decision based on what the app says? If it's tied into the NHS, it's provided by the NHS and linked to the NHS, then it's almost as if the decision it comes to is sanctioned by the NHS. So, who is responsible if something goes wrong?"

"If it's a drug that you're putting into your body, there's a clear causality. With wearables, there's a big gap there for the manufacturers of the products and for the health service provider to say that people were just using them wrong and that it's all down to the individual. So, there's enough wiggle room to get away with it."

Brought altogether it's quite the stalemate for any kind of wearable regulation at the moment but that may be because what we're describing is the very definition of a time where there isn't actually any needed. No one's dead because their running watch told them to sprint when they shouldn't and people are hardly piling on the pounds because of all the diet tracker apps out there either.

There is, though, a silent and growing danger as demonstrated by the popularity of some of the available smartphone medical software out there such as the $4.99 Instant Blood Pressure Pro. This app claims to be able to read your blood pressure without the need of a cuff but gets away with any inaccuracies and culpability by stating that it's not for clinical use. Nonetheless, that didn't stop it making it into one of the top 10 grossing apps in 2014 which is what worries Glasgow GP, Dr Des Spence.


"Our role as doctors isn't just about treating the sick, it's about protecting the well. I have a great anxiety that if you have an explosion of health apps which are unregulated and have lots of corporate money behind them, then it could be mayhem.

"Blood pressure, heart rhythm, foetal heart rate, oxygen saturation; these are my main issues as they have no background of testing. They're completely unregulated. All the stuff that we've ever done in recording these has largely been in symptomatic people and my concern is that if you stretch this into the worried world, what impact this might have.

I have a great anxiety that if you have an explosion of health apps which are unregulated and have lots of corporate money behind them, then it could be mayhem

"If you're monitoring your ECG for 24 hours, for example, well, that's never really been done with healthy people before so who knows what might turn up and how much health anxiety that might generate?"

That increase in health anxiety through the information age has seen large numbers of perfectly healthy 18-year-olds coming into Dr Spence's office convinced that they've got something terminal. Through the internet, the increase - and increase in availability - of media wherever we are, it's only natural that the spot on health issues has become more of a floodlight. While there are plenty of important connected home devices, such as those for the blood glucose measurement of diabetics, there are also ultrasound probes and foetal heart rate kits to feed the worries of the well but anxious.

"I think looking at your steps and heart monitoring your exercise is quite useful," said Dr Spence, "but when it starts getting into medical devices and medical monitoring, then that's a separate issue."

An "absolute disaster"

"Foetal heart monitoring, for example, could be an absolute disaster and it's just going to ruin people's sense of enjoyment of their pregnancy and make people paranoid. And people's interpretation of diet now seems to be one of prescriptions. It's not about enjoying food any more it's about making sure they're having guava beans and spinach. There's a sense of people losing touch with what life's about - enjoyment and not be too self-obsessive about anything.

"I think the problem is that we're just on the cusp of these things and the policy from the authorities has been a light touch to see how things play out. I think we should be concerned if there's no proper regulation of wearable devices because we need to make sure that they're accurate."

Just as with the internet, then, it's all about a game of catch up. We, who follow the wearables industry, know it has its shadier products with more spurious health claims but, so far, they've not done anyone any harm. There has been no public outcry with any manufacturers getting away with murder. We have not had our 'the satnav told me to turn left, so I drove off a cliff' stories in the press to gather enough momentum for the law makers to take notice. And, if no one's yet died through wearable-related disaster, then, well that's actually a very good thing and it would probably represent a bit of a waste of time if the likes of the FDA and MHRA were pointing their resources towards it.

Inevitably, though, those moments will come in one shape or another, be it the hacking of health implants or app-induced eating disorders. It would be nice if wearables could be regulated before these things happen but that's rarely how it works. Expect certification to come but a good old fashioned furore first. Regulation might make our wearables more expensive but it will also mean that they're going to be better than ever.

4 Comments

  • stevekennedyuk says:

    This is GOING to be an issue, as soon as a device allows you to make a decision based on the output i.e. say you display your ECG on a device (which is easy to do with simple electronics and a display) then you notice something YOU think is wrong and go to hospital and it's nothing, you've made an informed decision based on data from the device, worse if you have a problem and don't do anything from the data.

    As more devices come on to the market that can do diagnostics, they will need to get FDA/MHRA approval (and the approval process is costly and takes a lot of resources). Having worked in the medical electronics industry a long time ago (building an arrhythmia detector) the amount of resource spent documenting EVERY code change was huge (the code could be scrutinised by the FDA).

    That's why most fitness trackers on the market could offer a lot more functionality, but don't as they want to remain as fitness trackers rather than medical devices.

  • DGraingerMHRA says:

    There are quite a few misconceptions in this article about CE marking!

    Any product can be a medical device if it meets the definition. Our guidance https://www.gov.uk/government/publications/borderl... and  https://www.gov.uk/guidance/medical-devices-confor...may be useful to refer to.

  • VivekSilwal says:

    In general, products for sport or leisure purposes are not considered to be medical devices. However, in some cases, products aimed at sports people may be considered to be medical devices. This is usually the case where specific claims are made for the treatment of pain or injury and the product acts in a physical manner. 

    Examples of products considered to be medical devices are: 

    • heat / cold pads for pain relief 

    • bandages for sprains and similar 

    • support bandages 

    • gym equipment placed on the market specifically to measure, for example, heart rate or breathing rate. (Gym equipment that contains within it an element that measures heart rate is not a medical device because its primary purpose is as a piece of fitness equipment, not principally to measure a physiological function. Blood pressure monitors, even if intended to be used in a gym, however, would be considered to be medical devices).

  • VivekSilwal says:

    In general, products for sport or leisure purposes are not considered to be medical devices. However, in some cases, products aimed at sports people may be considered to be medical devices. This is usually the case where specific claims are made for the treatment of pain or injury and the product acts in a physical manner. Examples of products considered to be medical devices are: 

    • heat / cold pads for pain relief 

    • bandages for sprains and similar 

    • support bandages 

    • gym equipment placed on the market specifically to measure, for example, heart rate or breathing rate. (Gym equipment that contains within it an element that measures heart rate is not a medical device because its primary purpose is as a piece of fitness equipment, not principally to measure a physiological function. Blood pressure monitors, even if intended to be used in a gym, however, would be considered to be medical devices).

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