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Is a Fitbit fit for purpose?

The first Fitbit tracker was released over 10 years ago. Fitbit sold 11 million devices in 2020, and inmedical devices fitbit the same year, there were over 31 million active users of the device in place. People report it to be a great way to monitor their activity and encourage users to be more physically active and conscious of their wellbeing physically active. As time has passed, more styles and functionalities are being introduced to the market, making the Fitbit device equally about fashion as technology.

Premium subscribers can now access ‘health metrics’, which include ways they claim can help identify signs of ill health and medical issues. These metrics include breathing rate and heart rate variability (in addition to resting heart rate), skin temperature, and glucose level management tools. However, there are growing concerns about this reliance on technology in place of professional medical advice. Whether or not these devices are ‘qualified’ to highlight potential health risks or, more importantly, reassure people that all is well when in fact, it might not be.

The future of wearable technology

Over the past year, the Institute for Molecular Science and Engineering (IMSE) has led discussions between scientists, engineers, and medics from Imperial College London on what future wearable devices might look like and their relative merits and issues. Collectively they have put together a new briefing paper that investigates this in greater depth.

One of the paper’s key findings is that the divide between wellness devices such as Fitbit – designed to encourage a healthy lifestyle – and medical devices is beginning to blur.

For example, the latest Apple Watch has received medical approval to monitor atrial fibrillation. This is a potentially fatal heart condition that causes an irregular and frequently abnormally fast heart rate. A device that could help manage this could save lives, BUT it is only with this medical approval that it can make this claim.

Distinguishing between wellness devices and medical technology or functionality

It could be that this distinction is not clear to the average individual, and this opens the doors to other wellness devices offering heart monitoring without those medical accreditations. Users could become reliable on so-called heart monitoring functions in non-accredited wellness devices without their knowledge. Consumers are not actively informed about the medical certification; therefore, they wouldn’t be aware of this at the point of purchase without in-depth research.

There is currently no regulation for wellness devices in place, aside from the standard Trade Descriptions Act that equally applies to entertainment technology such as children’s toys and game consoles.

In a joint event involving the IMSE, professionals from the Medicines and Healthcare products Regulatory Agency (MHRA), the Information Commissioner’s Office, and Imperial researchers addressed the lack of regulation. They concluded that as the industry grows, clear guidance on wellness devices is needed now.

They also agreed that future regulations should bring together a multidisciplinary team that includes more than just wearable technology companies, medical technology companies, and programmers. It should also include regulators, relevant academics, and medical professionals.

The future of wellness devices

Wellness devices can positively influence society, and any technology that encourages people to be more active and tackle the obesity crisis across the western world can only be a positive thing. But when people rely on technology to monitor their health, this data being anything less than 100% accurate and fit for purpose could be life-threatening. Furthermore, it needs to be an accredited medical device, or that functionality within a device needs to be accredited. Therefore, the regulation is imperative to ensure a clear definition between medical and wellness to a consumer audience, and that caveats are in place to demonstrate data reliability.

At Morgan IAT, our core USP is our medical device development, partnering with medically accredited organisations and bodies to innovate technology that benefits society. See our current and past projects here

 

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