Perspectives
Smartphones and wearable technology:
benefits and concerns in cardiology
The global expansion of wearable technology combined with smartphone access creates new
questions and opportunities in the diagnosis and management of cardiac conditions
W
earable devices along with smartphone
technology are becoming more common in
developed nations such as Australia, with
the number of connected devices expected to increase
from 526 million in 2017 to over 1.1 billion worldwide
in 2022.1 This new source of health information has
led to novel methods of patient assessment, such as
a single-­lead electrocardiograph (ECG) creating a
pre-­presentation observation chart. This creates a
paradigm shift where instead of symptomatic patients
being referred for cardiac assessment, asymptomatic
patients are now presenting with health data. In this
article, we discuss the technology behind the devices,
common brands and formats, potential applications,
and advantages and disadvantages of wearable devices.
Devices
At the time of writing, there is a plethora of patents
worldwide, with 423 devices from 132 brands in wrist-­
worn trackers alone.2 However, few brands are featured
in research, the most common being Fitbit (Fitbit, Inc),
Garmin (Garmin Ltd), Misfit (Misfit Technologies),
Apple (Apple Inc) and Polar (Polar Electro). Some
of these devices are generally not classified by the
United States Food and Drug Administration, such as
the Garmin and Fitbit fitness trackers, as they are not
marketed directly as health treatment devices. Devices
can broadly be grouped into three types: chest-­strap
devices, photoplethysmography (PPG), and portable
single-­lead ECG (Box 1 and Box 2).
The first wearable technology devices created were
chest-­strap devices which used electrodes to record
heart rate.3 They differ from modern ECG based
devices in that they do not record an actual rhythm,
David Jin1,2
despite being able to measure chronotropic response to
Heath Adams1,3 a correlation efficient of > 0.93 compared with ECG.4
Anthony M
Cocco1 The next set of technologies uses PPG. This technique
1 involves optical technology to assess variations in
William G Martin
blood volume within the microvasculature,5 effectively
Sonny Palmer 1,2 measuring each heart beat as a pulse, similar to
MJA 212 (2) ▪ 3 February 2020
pulse oximetry used in hospital settings. Accuracy
1
 St Vincent’s Hospital is often limited by anatomical factors including
Melbourne, Melbourne,
VIC. location, movement, skin colour and conductivity.
2
 Medicine at St Vincent’s Fingertip PPG is highly accurate, with meta-­analysis
Hospital, University of demonstrating a mean difference of 0.32 beats per
Melbourne, Melbourne,
VIC. minute (99% CI, − 1.25 to 0.60) compared with ECG.6
3
 University of Tasmania, Smartphones are the most commonly used device to
Hobart, TAS.
feature PPG; however, wrist-­worn devices also exist,
david.jin@ such as smart watches and heart rate tracking devices.
outlook.com These are reasonably accurate, with correlation
coefficients > 0.93 and mean absolute percentage errors
54 doi: 10.5694/
mja2.50446
ranging from 3.3% to 6.2%.4
The latest set of devices use a built-­in electrode system
to create single-­lead ECG, such as the Apple Watch
Series 5, enabling more advanced analysis. These
devices require the patient to hold the watch in the
contralateral hand, touching the crown or band of the
watch, creating a vector to generate a second lead. The
other most common ECG device is a small tablet, such
as the Coala (Coala Life Inc) and Zenicor-­ECG (Zenicor
Medical Systems).
Applications
Wearable technology is used in heart rate tracking,
with high levels of accuracy in both smartphone6 and
wrist-­based formats.4 Relevant clinical assessments
are similar to conventional ambulatory ECG monitors
and include measuring adequate rate control in
atrial fibrillation (AF), and aiding the diagnosis of
bradyarrhythmia or tachyarrhythmia.
Although PPG sensors were initially only designed
to track heart rate, there has been a push to use these
with algorithms in the detection of arrhythmias such
as AF. One analysis created an algorithm using data
from 9750 participants, including 347 with AF; overall
sensitivity was 98% and specificity was 90%.7 The
largest such study to date has been the Apple Heart
Study, a wearable PPG study using the Apple Watch,
in which 419 297 people self-­enrolled.8 The aim of the
study was to identify irregular pulses on PPG, and
the diagnosis of AF with a confirmatory ECG patch.
A total of 450 ECG patches were included based on
PPG analysis by doctors, with AF documented in 34%
of these patients. In patients ≥ 65 years of age, the
rate of irregular heartrate notification was 3% with a
positive predictive value for a final diagnosis of AF of
84. Several limitations were noted, including a self-­
enrolment selection bias of possible health conscious
individuals, a lower than expected target enrolment,
and reporting bias with only 68% of ECG patches
returned to the study organisers.
Manufacturers are now expanding beyond PPG to
electrode based technology. This aims to detect AF
not through beat-­to-­beat variation, but via single-­lead
electrode printout. This was demonstrated in the
REHEARSE-­AF Study,9 which involved 1001 at-­risk
patients (CHADS-­VASc score ≥ 2), leading to the
subsequent diagnosis of AF in 19 patients compared
with five patients in the control arm. Orchard and
colleagues found that of 1805 Australian patients
screened by their local general practitioner,10 67 (3.7%)
were diagnosed with possible AF by the algorithm
and 19 (1.1%) were formally confirmed by 12-­lead
ECG. The authors estimated that the costs would
approximate $1000 in set-­up fees, as well as $10 per
 Perspectives
analysis of cardiac rhythm,13
1  Selected examples of wearable technology and smartphone and a trial using electrode based
­photoplethysmography (PPG) technology resulted in 34% of
the recordings being
unclassifiable.
Another key limitation is that
for these devices to be available
in Australia, they require
approval from the Therapeutic
Goods Administration (TGA).
Importantly, Apple has not
received such approval for
their ECG app on the Apple
Watch, meaning it is currently
unavailable in Australia.
However, there are current
recommendations to streamline
this approval process.
Further questions arise regarding
the medical implications and
ethics of these newly available
data, as they create previously
unstudied situations. For
example, does a single bout
of asymptomatic AF detected
on a wearable device require
further investigation or warrant
therapeutic anticoagulation?
There are only a few studies
A: Polar H10 chest strap device. B: Garmin Forerunner 735XT PPG based wristwatch. C and D: Samsung S9
smartphone and Samsung Health PPG based app. E: Coala Heart Monitor electrode based device. F: AliveKor which look at subclinical AF, all
KardiaMobile electrode based device. ◆ with varying results, with one
subgroup analysis showing that a
patient, on top of normal consultation fees.10 Although significant increase in stroke risk only occurs after 24
evidence for wearable technology is currently scarce, hours of sustained AF.14
this potentially represents a cost-­effective way of
If an arrhythmia is recorded by the device, does
implementing opportunistic age-­appropriate AF
11 medico-­legal responsibility lie with the company,
screening as per local guidelines.
the patient or a medical professional to interpret and
Another area in which portable technology may be manage this finding? What if the technology or patient
useful is the correlation of symptoms with arrythmias choices result in individuals being lost to follow-­up?
to guide diagnosis and treatment. There is increasing This was seen in the Apple Heart Study, where only
evidence favouring the use of electrode-­based portable 68% of patients returned ECG patches.8
12
technology due to ease of access and availability,
Ethical concerns also exist around data: are they the
particularly in patients presenting with infrequent
property of the manufacturer, and are they freely
symptoms that may not be captured on traditional
available to influence epidemiological research? From
event recording.
an individual point of view, will these asymptomatic
One of the strongest advantages of wearable devices findings affect future private insurance premiums? If
is their ubiquity and ease of use, which may allow for portable technology does become universally adopted
screening and further monitoring in a large population and accurate screening algorithms are identified,
of patients. This is relevant in Australia for those will governments be able to perform screening to
located in regional and rural areas with limited access benefit public health? The issue of health equality is
to specialist investigations. Future options include the also of concern, as those with higher incomes may
MJA 212 (2) ▪ 3 February 2020

newly approved 6-­lead ECG by AliveCor. In addition to have access to devices not attainable for others. There
the two-­finger electrode, this includes a third electrode are also concerns regarding the limited research into
on the back of the device, which extends to the patients such devices, and the potential risk of exaggerated
left knee, creating Einthoven’s triangle and producing marketing claims on their benefit, with multiple fraud
limb leads (I, II, III, aVR, aVL and aVF). claims documented previously.15
Finally, there are concerns around the cybersecurity
Concerns and limitations and regulation of novel devices, for which there is
both minimal regulation and large variance on the
One of the limitations of wearable technology devices aforementioned factors. Security is heterogeneous
is the data itself, not data interpretation. PPG analysis between devices, with concerns regarding who
has been shown to have significant variability in the physically owns the data once they are collected, and 55
 Perspectives

2  Summary of common wearable technology devices

Device type Common devices Technology Advantages Disadvantages

Chest-­s trap devices • Polar H10 Electrode based • Highly accurate • Cumbersome
• Garmin • Offers continuous • Not often worn routinely
HRM-Run measurement

Wrist-­worn devices • Garmin range PPG • Convenient and portable • Less accurate than other
• Fitbit range • Offers continuous technologies
• Samsung Gear measurement
Fit
• Apple Watch
Series 5

Wrist-­worn rhythm • Apple Watch Electrode based • Single-lead ECG available • Apple Watch ECG not
devices Series 5 (in ECG (single-­lead • FDA approval available in Australia
mode) ECG) • Requires active
measurement by patient
(non-continuous)

Smartphone based apps • Apple iPhone PPG • Highly accurate • Requires active
• Google Android • Highly prevalent measurement by patient
(non-continuous)

Portable rhythm devices • AliveCor Electrode based • Single-lead ECG available • Requires active
KardiaMobile (single-­lead • FDA approval (Alivecor and measurement by patient
• Coala Heart ECG) Coala) (non-continuous)
Monitor
• Zenicor-ECG
ECG = electrocardiograph; FDA = United States Food and Drug Administration; PPG = photoplethysmography. ◆

whether the data are available to the company to
market, even if de-­identified.
Conclusion
Wearable devices and smartphones are a widespread,
globally adapted form of technology that is only
exist. Further evidence and guidelines are required to
clarify the role of wearable devices from a therapeutic
standpoint as well as the medico-­legal and ethical
implications of arrhythmia identification.
Acknowledgements: We acknowledge Gadfit.com for providing images
of the Garmin Forerunner 735XT PPG based wristwatch. We thank Dr
Rebecca Dang for her contributions that greatly improved the manuscript.

expected to increase. This presents new challenges for Competing interests: No relevant disclosures.
clinicians to assess patient data, particularly in relation
to the analysis of rate and rhythm in asymptomatic
Provenance: Not commissioned; externally peer reviewed. ■
patients. We suggest that clinicians be aware of the © 2019 AMPCo Pty Ltd
potential benefits and applications of this technology,
as well as the concerns and limitations that currently References are available online.
MJA 212 (2) ▪ 3 February 2020

56

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