Instrumentation & Measurement Magazine 24-6 - 89

Wearable Devices and Diagnostic
Apps: Beyond the Borders of
Traditional Medicine, But What About
Their Accuracy and Reliability?
Gloria Cosoli, Susanna Spinsante, and Lorenzo Scalise
N
owadays people are willing to self-monitor their
health status, and when they do not feel well, they
tend to ask Dr. Google for a diagnosis (over a third
of adults go online to analyze or look for information about a
health condition [1]). People trust technology, often more than
physicians; smartphone and Artificial Intelligence (AI) technologies
are undoubtedly making innovative monitoring and
diagnostic devices rapidly progress, so much that it seems that
the future of medicine is in smartphones, where apps may run
and to which devices can be connected, hence supporting mobile
health (m-Health) [2]. In addition to smartwatches and
wrist-worn devices that are surely the most common wearable
devices [3], [4], there are also connected wearable clothes [5],
socks [6], rings, or glasses-type wearables [7].
But, how accurate are these instruments? How much is it
possible to trust Direct-to-Consumer (DTC) diagnostic apps?
Generally, neither wearable devices nor diagnostic apps are
properly classified as medical devices, and, consequently, no
one formally worries about the reliability and the accuracy of
the information provided. Despite this, at present it is unquestionable
that both apps and devices are used in applications
dealing with medicine and health-related issues (confirmed
by the high number of publications on this topic in Health professions/Medicine
journals), such as in the Ambient Assisted
Living (AAL) context or monitoring of ageing people at home
or during rehabilitation (for example, with activity recognition
purposes). Driven by the current global health issues, some ongoing
research studies even suggest the adoption of wearables
in the context of pandemics [8].
It is easy to understand that if this information should support
clinical decision-making, reliability is a key aspect to
consider; caregivers could also use the information provided
for recommendations on lifestyle or to support therapeutic
strategies. Moreover, when a user chooses her/his own
wearable device or which diagnostic app to download, she/
he should have sufficient technical information to carry out a
proper comparison among the marketed options, and also to
select the device nearest to the desired purpose (e.g., health or
fitness [9]). On the other hand, diagnostic apps should provide
September 2021
advice on calling a physician or not, but their performance
has been little explored and the methods used for the evaluation
are barely reported and often not clear; furthermore,
there are no studies related to their real-world use reporting
the evidence on their risks and benefits on individual health.
The research interest on wearable devices and self-diagnostic
apps is continuously growing, proved by the increasing literature
related to them [10], and more attention should be paid
to accuracy and performance assessment, besides appropriate
development and use that will guarantee continuity of care.
This paper aims to underline the lack of homogeneous
methodologies for the quantitative evaluation of the more and
more widely used innovative health-related devices, namely
wearable devices and diagnostic apps. Considering that there
is a rapid evolution of these technologies, it is of paramount
importance to define thorough and standardized methodologies
for the evaluation of their performance, especially in
terms of physiological measurements accuracy.
Wearable Devices: Overview
In recent years, the use of wearable devices has risen because
of multiple reasons: on one hand, people wish to self-monitor,
tracking their physical activities and assessing the basic parameters
that depict an overview of their health status (e.g.,
Heart Rate (HR), energy expenditure, sleep quantity and quality,
and blood-oxygen saturation (SpO2
)), as summarized by
Fig. 1 (including normal ranges for HR, interbeat intervals
(RR), skin conductivity, peripheral temperature, and respiration
rate parameters).
Moreover, the importance of physical activity is being
publicly underlined for health improvement and disease
prevention; therefore, a considerable number of people, particularly
in technologically advanced countries, wants to
quantify activity to improve habits, if needed. In fact, nowadays
the awareness of the importance of a healthy and active
lifestyle is continuously stressed as early as school age, and
through social media posts, advertising, and experts' opinions,
as has pushed people's motivation and thus led to the
willingness of monitoring health and activity. The market is
IEEE Instrumentation & Measurement Magazine
1094-6969/21/$25.00©2021IEEE
89

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