Smartwatches are a constant companion for many, but nowadays they do a lot more than just tell the time. Consumer tech companies like Apple, Samsung, Fitbit and Garmin have all worked hard to gain a competitive edge in the smartwatch arena and in recent years that has involved pushing into the medical space.
Now the question we ask when a new smartwatch is released isn’t ‘what does it look like?’ or ‘how well does it tell the time?’, it’s ‘what new features does it have?’.
Smartwatches can now do things like track your sleep, measure your body composition and take an electrocardiogram (ECG) reading. However, devices with these features have to go through lengthy approval processes before they can be activated for use.
This happened most memorably with the Apple Watch’s ECG features, which saw Aussies receive the nifty new feature years after our friends in the U.S..
Shortly after Apple had its ECG monitoring approved by Australia’s Therapeutic Goods Administration (TGA), a wave of similar approvals followed for both Samsung and Fitbit’s new devices.
This situation made clear how integral regulation and approval is in Australia for any device hoping to fulfil a medical function.
To understand more about the approval of medical features in Australia and where smartwatches could go next, Gizmodo Australia consulted some experts.
What does it take to get new features on a smartwatch approved?
For years Australian customers wondered why certain features on their smartwatches weren’t available here.
The answer is mainly two-fold. First, an application for approval needs to be submitted to the TGA and then the device needs to pass certain requirements.
“All medical devices have to demonstrate that they meet certain safety, quality and performance requirements,” a TGA spokesperson told Gizmodo Australia in a statement over email.
“The TGA undertakes a risk-based approach in relation to the type of evidence required and the assessment process when approving medical devices, including software with therapeutic functions.”
The devices are also judged based on what kind of information will be displayed as well as who is intended to read this information.
“For software devices, in summary, we use a classification system that considers if the device will be used by a health professional, or by a consumer and the type of information that is being generated or displayed to the user. This reflects the importance of ensuring that information displayed is appropriate for the user,” the TGA spokesperson said.
“For example, there is a greater risk of potential patient harm with devices that generate or display specific treatment, treatment suggestions or diagnosis when a healthcare professional is not involved. Therefore the level of oversight by the TGA can range from low to high, depending on this risk.”
There’s also the manner of the application. Without an application for a device to be listed on the Australian Register of Therapeutic Goods (ARTG), it can’t legally be sold in Australia. This seems to be why the Apple Watch’s ECG features were so delayed.
In 2020 the TGA provided Gizmodo Australia with a statement saying that the “TGA has not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG”.
This was two years after ECG features were introduced to the Apple Watch in the U.S..
The TGA said that in order to submit an application “evidence must be provided to show that the manufacturer of the medical device is appropriately certified to manufacture that type of device”.
“The manufacturer is also required to hold evidence that demonstrates the device is safe, fit for purpose and will perform as intended. Depending on the classification of the device, the manufacturer and/or supplier may need to have a third party certification undertaken by a recognised auditor or regulatory body.”
The applicant is also legally held responsible for the sale and ongoing safety of the device in Australia.
Back in 2020, Apple had declined to comment on why an application hadn’t been submitted for the ECG features so it’s still unclear as to why it took so long.
Do these medical features have any real-world benefit?
So the application is submitted, the TGA approves it, you buy a smartwatch and now you have all these fancy new medical features at your disposal. Consumers will pay top dollar for a new smartwatch but can it really be a replacement for something like a blood pressure cuff or pulse oximeter?
Gizmodo Australia spoke with Dr Michael Bonning, chair of the Australian Medical Association (NSW) council, to get some more insight into the real benefits of a smartwatch.
The bottom line is that smartwatches aren’t intended for diagnosis but the indicative data supplied by a smartwatch can retrospectively help practitioners inform their patients.
“These devices help you look at interesting anecdotal things about yourself,” Dr Bonning said. “Maybe we can start to infer things about recovery and rehabilitation and use that data to inform what we do with you next, rather than just make a diagnosis.”
In terms of real-world data about the correlation between smartwatch data and a health diagnosis, Dr Bonning said it was mainly anecdotal.
“We don’t necessarily see [patients] coming in and saying ‘something’s going on can you have a look at my watch?’. It’s still a fairly niche application of them at this point in time. If someone does have something weird happen with their heart, they will likely feel that themselves and then look at their watch or decide whether they need to go to the hospital or see their doctor,” he said.
“Lot’s of these things are symptomatic. The watch isn’t necessarily providing more data.”
The advantages of wearing a smartwatch
Despite the lack of real-world data to date, there are still certain benefits when it comes to wearing the medical technology in smartwatches.
Dr Bonning said that one of the main advantages is the fact that it’s packaged in the form of a watch, rather than an uncomfortable medical device.
“The cool thing about them, in the long term, is that you wear them,” he said. “A lot of times you’ll hear people don’t wear their medical devices because maybe it’s bulky or there’s not enough space. Whereas if you’ve got a watch that does all these things it’s really practical.”
This is where a distinction between a medical alert device and a medical device starts to come into play.
“In an event where you’ve fallen down on the ground and can’t get up because you broke your hip, [a smartwatch] is really beneficial. That’s the difference between being a medical alert and a medical device. There’s a lot of space in the medical alert environment to use a smartwatch,” he added.
Dr Bonning encouraged people to think of these devices as more of an incentive for the patient to engage with their own health rather than a replacement device.
“If we focus on it being the technology and that it creates an incentive or a moment where the patient wants to come and engage with something, I think it’s really useful if it’s thought about in that way. Rather than it’s a replacement device for my ECG,” Dr Bonning said.
The convergence of smartwatches and medical devices is also helping to democratise access to medical technology.
“As a practitioner, I really am supportive of the idea of good consumer technology bridging that gap into medical technology. Over time it will democratise access to this kind of stuff,” he said.
“If you’re selling hundreds of thousands of smartwatches a year in Australia, and you can build a technology feature into them, then the cost of having access to that is much lower for everyone.”
What about the problems?
The idea that a smartwatch is simply a catch-all replacement for going to the doctor is where things start to go wrong. In all their Ts and Cs, smartwatch manufacturers make it clear that their devices are not built for diagnosis.
“The device is not intended to replace traditional methods of diagnosis. Consult a doctor if atrial fibrillation is detected or if you have symptoms of a heart attack, stroke or other cardiovascular conditions,” the product page of the Apple Watch Series 7 reads.
Similarly, the disclaimer for Samsung’s Galaxy Watch4 Blood Pressure monitoring feature reads “intended for general wellness and fitness purposes only. Not intended for use in detection, monitoring, diagnosis, treatment of any medical condition or disease”.
Dr Bonning agreed that the idea of treating a smartwatch like a diagnostic device was “problematic” because the results still need “significant interpretation”.
“The limitations of something especially like an ECG on a single site, like the wrist, is very different to the quality of interpretation that comes from an ECG across the whole body,” he said.
There’s also the hesitation from medical practitioners to embrace the technology in smartwatches. A lot of this difficulty stems from proprietary software that would allow a patient’s data to come into a clinician’s computer system.
“People are very cagey about their health data and medical file being shared with someone but we share other data about ourselves at will. I actually expect there would be a fair bit of interest in sharing data with a healthcare provider if they said to you we think this could be useful,” Dr Bonning said.
Systems that allow patients to share health app data with their doctors directly are already in the works.
Last year it was reported that some Apple Health users in the U.S. could trial an option that allowed them to share their app data with their doctor through electronic medical records.
Given the rise in the use of digital vaccine certificates lately and the implementation of My Health Record, sharing health app data doesn’t seem like a far-off reality.
Where is smartwatch medical technology heading?
Smartwatch medical technology advances significantly year by year. ECG was a major step in the arena but now everyone’s wondering, what is next?
“There are lots of developments in photonics sensing,” Dr Bonning said.
“We can move it into the respiratory system, we can probably move it into things like the vasculatures and see how our blood vessels perform. We can look at changes associated with our concentration of different systems like red blood cells and haemoglobin. All those things can be inferred from those light systems. But it depends on whether the technology is there and if we can reproduce it.”
Dr Bonning also pointed to research that was being done with audio sensors to measure sound waves. Monitoring the sound of blood travelling through your body could potentially help a device take a blood pressure reading in the future.
Rumours circulated last year that the new Apple watch may have blood pressure and fertility tracking features and that the next Samsung watch may have a non-invasive option for blood glucose monitoring.
Neither of these are confirmed as of yet but there’s no doubt the medical technology in smartwatches is certainly advancing. Now it just needs to progress to a point where our regulators can test and approve so it can make its way onto our wrists.
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