Tracking Trouble? Why Doctors Aren’t Sold on Wearables.
At the end of 2024 I was talking to a local GP as part of a research project and she mentioned that the number of patients’ who are booking appointment as they are worried about the data from their wearable. She believes this is starting to impact further her workload as the ‘worried well’ are bringing their concerns about sleep quality, heart rate etc taken from their wearable data. Particularly as they don’t require further investigation and are wasting her precious clinical time. But she did point out that wearable data has been useful to find anomalies like arterial fibrillation which she potentially wouldn’t have picked up.
This was a timely conversation as BBC News had just reported that doctors were wary over the use of wearables within NHS services. With concerns cited over unnecessary GP appointments due to increased patient anxiety, the accuracy and reliability of the data and the potential for false positives where wearables illustrate unnecessary alerts.
Wearable devices like Apple, and Fibit can track vital signs including heart rate, oxygen levels, and physical activity. These continuous data streams could provide many benefits:
Clinicians have access to comprehensive, real-time picture of their patient’s health pulled into their electronic patient record. Enabling more personalised and faster decision-making whilst being able to properly risk-stratify their case load.
Leveraging AI algorithms, the patients’ data could detect patterns or anomalies delivering proactive health management, whilst offering opportunities for screening programmes e.g. heart disease.
Fast forward and last week, I attended the Whittington Hospital to have a 24 hour blood pressure device fitted. The cardiac physiologist brought out the most bulky and intrusive blood pressure monitor I’ve ever seen. As we’re talking, I show her my slimline wearable Aktiia bracelet, this CE mark class lla takes three measurements every hour with data recorded and displayed via the app.
The cardiac physiologist responds with “we’re a long way from using that device in the NHS”, even though I explain it has five clinically validated trials to demonstrate its clinical accuracy for ambulatory blood pressure monitoring.
To which the response was “but they aren’t affordable for us to buy”. Now mine cost £188 and the app is free. From a patient experience perspective the BP device the hospital provided me was hugely restrictive (I couldn’t take a shower in those 24 hours) with huge tubes trailing down. Nightime was a disaster as the cuff inflated loudly every 30 minutes. Plus I found that the device kept reporting errors when taking my measurements, so I have no idea how accurate the report back to my GP will be (they refused to email me the results). They could have used the data from my Aktiia wearable which is also calibrated once a month by pairing with their specially designed BP cuff.
So, what is stopping the NHS from purchasing evidence-based wearable. The increasing pressure on NHS services alongside the push for out of hospital care creates the right condition for integrating wearables into clinical pathways. Financially, there could be significant savings generated. For example, the Whittington could have lent me a £188 wearable, delivered to my address with a return process to send it back. As opposed to currently the hospital appointment which required clinical and admin resource, expensive estate costs and low-grade medical equipment (costing at least £200+).
There is definitely a wider discussion needed to ensure that clinicians have the confidence and capacity to use regulatory approved wearables into clinical pathways. For wearables and / or their data to be trusted and safe, they need to be CE / UKA / FDA regulated to alleviate concerns about consistency and reliability. For example, clinical trials found the Aktiia bracelet is as accurate as accepted reference measurements; accurate in multiple body positions, and for people with higher skin pigmentation (Fitzpatrick ≥ 3).[1]
Resources for innovators
For health tech companies the Department of Health and social Care has useful guidance ‘a guide to good practice for digital and data-driven health technologies’.
The route that the Aktiia team have taken with their evidence generation is a good case study for any company going down this route.
Legal Foundations (a not-for-profit with a mission of improving access to legal services for startups and SMEs) has produced useful blog ‘Legal considerations for UK start-ups in the wearable technology sector’.
[1] To be used in clinical decision-making they would need to be regulated as Class I medical device for meeting CE regulation.