The main components of the SMART-BEAR
cloud platform include databases and its underlying
information model, clinical repository interfaces, a
Big Data Engine, a data collection dashboard, and
analytics. The analytics and personalisation
components leverage the SMART-BEAR FHIR-
based Information Model. Separately from the cloud
platform, a smartphone application collects
information on the patient's basic physiological,
medical and behavioural parameters (such as steps
walked daily or weekly, weight in Kgs, or blood
pressure). This information is collected by means of
smart devices that are provided for one year (12
months) to each participant according to their
comorbidities and needs.
In recent years, there has been an increased
interest in e-health monitoring systems situated at
homes, leading to the creation of Health Smart
Homes. Such technologies can facilitate monitoring
patients' activities and enable efficient, decentralised
healthcare services at home. This type of monitoring
may improve the quality of care for the elderly
population and increase their well-being in a non-
obtrusive way. This approach allows for greater
independence and empowerment, maintaining good
health longer, preventing social isolation for
individuals, and delaying their placement in
institutions such as nursing homes and hospitals. The
recent advancements in the IoT technology, the
improvements with respect to user-friendliness, and
the significant cost reduction need to be considered as
well. This current wide use (compared to previous
periods) was enabled by major advances in wireless
technology and computing power, leading to a
plethora of diverse and specialised Medical IoT
(MIoT) that can generate and transmit data via open
protocols – and later, to be picked up and analysed.
It is not just the increase in the supply of
affordable MIoT monitoring medical and well-being
measurements that is changing the landscape in
personalised medicine and consumer health. The
data, generated at a rapid rate, along with the devices
themselves, are creating a connected infrastructure of
medical devices, software applications and health
systems and services, that is transforming healthcare
delivery. Nowadays, the evolution of e-health
systems equipped with Big Data Analytics (BDA)
capabilities permits the provision of good quality
decision support, enhancing care delivery. The
efficient information exchange and data reusability,
together with the utilisation of data mining and ML
analytics help to convert information into knowledge
(Dash, Shakyawar, Sharma, & Kaushik, 2019).
With all the progress achieved in this domain,
challenges remain in how to use the information and
the derived knowledge productively and in a way that
can be evaluated systematically, as the scientific
community does not have a commonly accepted way
of capturing it, while industry traditionally invests in
technological solutions that can be commercially
exploited. The HL7 (Health Level Seven) FHIR (Fast
Healthcare Interoperability Resources) standard, a
well-known specification that can be used for the
representation of clinical data, provides the
underlying basis for our data harmonisation solution.
Accompanied by well-defined semantics captured
using widely adopted ontologies such as LOINC and
SNOMED-CT for the semantic representation of
data, the standardised data representation helps
streamline the development of analytics and decision
models with the potential to provide accurate,
personalised interventions via decision support tools.
These tools digest the harmonised information and
facilitate decisions that are vetted by health
professionals to ensure patient safety.
Along with the production of knowledge, the
dimension of data protection needs to be adequately
addressed. Processing of sensitive personal data must
be compliant with all relevant legal requirements and
privacy obligations laid down by national legislation
in addition to those imposed by the General Data
Protection Regulation (GDPR), a legal framework
that fundamentally transformed how personal data
must be managed lawfully. In this context, it is not
enough just to have in place organisational
procedures along with IT-supported processes for
exercising certain GDPR rights. Vulnerabilities do
happen, even within the best organised and best coded
IT systems. Therefore, mechanisms to ensure the
security and privacy of the data held, the integrity of
any platform storing and managing them (integrity,
confidentiality, and availability of data at rest, in
transit and processing for data flows), in a continuous
security and privacy assurance approach, are of
paramount importance. On this axis, and given the
legal obligations imposed by the GDPR and the state-
of-the-art guidelines (e.g., encryption guidelines of
NIST), data minimisation, pseudo/anonymisation,
transparency in processing personal data, and audits
support are among the appropriate technical (and
organisational) measures that must be taken into
account, preferably at early stages, to ensure that all
legal requirements are met.
Last but not least, Big Data Analytics (BDA)
systems for healthcare decision-making must not only
focus on the production of ML knowledge but also
convey it in an easy-to-use way, accompanied by