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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Implementation of Cloud-Based Personal Health Record Integrated with IoMT</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Natasha Blazeska-Tabakovska</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Andrijana Bocevska</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Ilija Jolevski</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Blagoj Ristevski</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Nikolaos Beredimas</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Vassilis Kilintzis</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Nicos Maglaveras</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Snezana Savoska</string-name>
        </contrib>
      </contrib-group>
      <fpage>178</fpage>
      <lpage>188</lpage>
      <abstract>
        <p>The paper presents implementation challenges for the cloud-based Personal Health Record (PHR) for Cross4all project with the usage of healthcare sensors according to the concept Internet of medical things (IoMT). The purpose of the paper is to highlight the implementation obstacles and solutions for the proposed PHR base model connected with cross-border healthcare systems that introduce a PHR concept. The paper also intends to assess the needed effort for increasing digital and e-health competences of the participants, supporting strategy where the patient is the owner of data and the key point of data collection. The increased need for e-health and digital health literacy for project implementation in the region has to be one of the main prerequisites for the acceptance of the concept by medical professionals and patients. In the PHR system patients will also have the opportunity to upload scanned medical documents as PDF or DICOM Media about their diseases and treatments available for the doctors. The data of the patient will temporary be at the disposal of the selected medical professionals in order to have information for decision making. This type of patient-centric data integration has to bring many benefits for patients and medical staff in the process of improvement of patient care.</p>
      </abstract>
      <kwd-group>
        <kwd>Personal Health Record</kwd>
        <kwd>Patient's Centric Data Integration</kwd>
        <kwd>CloudBased PHR</kwd>
        <kwd>Internet of Medical Things</kwd>
        <kwd>Healthcare Sensors</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>Introduction</title>
      <p>Many hospitals, healthcare institutions, medical and clinical organizations as well
as healthcare insurance companies and funds have induced digitization at their
baseline to boost the quality of healthcare delivery. Driven by this phenomenon,
the industry has transformed itself into a massive giant, accomplishing the
mandatory requirements and further igniting its potential to refine the deliverables
at minimal costs. While this transformation indeed brought about a revolution in
the healthcare industry, it also invented the generation of huge amounts of data.</p>
      <p>
        Nowadays, it is a widely known fact that these big data can hold many
capabilities for the healthcare industry if it is processed and executed appropriately
[
        <xref ref-type="bibr" rid="ref1">1</xref>
        ] [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. The data is a reliable prospect for supporting a wide range of medical and
healthcare functions, including clinical decision support, disease surveillance and
population health management. This data is the key to optimizing the potential
of the healthcare industry not just from the industry perspective but also from
the consumer perspective. Also, it is a huge opportunity for data scientists to
further improve healthcare standards, given the overwhelming amount of data being
generated and stored. Their analysis is very important in many management and
policymaking at state levels.
      </p>
      <p>The other aspect of patient-centric data collection is also very important in
order to provide fast reaction by the medical practitioners when a patient needs
urgent medical help anywhere. The ability to have a single dashboard for patients’
entire history has a big effect on the healthcare sector. In other words, the
patients’ centric data integration can bring many advantages for patients especially
in the era of their increased movement possibilities. Electronic health records
(EHR) and personal health records (PHR) have a big impact on cross-border
e-health services. Being able to share lifelong EHRs of patients among different
healthcare providers in different countries, provides better decision support.</p>
      <p>The project Cross4all proposes patients’ centric data integration, the
cloudbased PHR has to be the central point of data collection for the patients integrated
with IoMT, adding many possibilities connected to entering their document,
sensors’ data, prescription and referral data as well as omics and exposome data
connected with patients.</p>
      <p>The paper describes the implementation of a cloud-based PHR system
available cross-border in a real pandemic environment, explaining many obstacles
and solutions arising from the current situation in the process of implementation
of Cross4all project. After the introductory section, the second section surveys
the recent research. In the next section, the paper considers some points of
project aim and purposes, prerequisites and security and safety standards, taken into
account in the phase of software creation. The next section describes some real
solutions for cloud-based PHR and obstacles that arise from the low level of
digital health and m-health competencies of the project participants. The concluding
section contains supportive concluding remarks and draws the possible action to
solve particular obstacles, improve some issues in the project implementation and
propose some project improvements.</p>
    </sec>
    <sec id="sec-2">
      <title>Related work</title>
      <p>
        The research of the area of integration of healthcare and medical data usually
is connected with a large investment of healthcare providers in de-personalized
decision support systems intended for planning state, municipality or hospital’s
medical and healthcare. This research area takes into consideration the data
security and patients’ privacy risks related to the secondary uses of EHR especially
when EHR data are transmitted through a network and shared and exchanged
with multiple stakeholders [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ]. But, many researchers state that the data from
EHR can be effectively used in different domains such as clinical research, public
health surveillance and clinical audits to provide effective, timely and quality
healthcare facilities to the patients as well as for clinical research [
        <xref ref-type="bibr" rid="ref4 ref5">4, 5</xref>
        ]. They also
consider the patient’s data reuse privacy in many details.
      </p>
      <p>
        The concept of “health digital state” [
        <xref ref-type="bibr" rid="ref6">6</xref>
        ] is used by EHRs to improve health
digital state (HDS) with intelligent support of the processes of diagnoses and
treatment, enhancing the prediction of pattern of diagnosing progression and
defining the precise medical treatment and therapy as well as personalized
delivery of healthcare [
        <xref ref-type="bibr" rid="ref7">7</xref>
        ]. The situation is changed when the Internet of Medical
Things (IoMT) platform for pervasive healthcare is taken into consideration. This
platform has to provide interoperability, quality of the detection process,
scalability in a machine-to-machine-based architecture and functionalities for
processing huge data volumes, knowledge extraction, common healthcare services
and connection with PHR/EHR [
        <xref ref-type="bibr" rid="ref8">8</xref>
        ]. IoMT devices use the semantics defined in
OpenEHR for data quality evaluation and standardization of healthcare data. It
also enables the application of big data techniques and online analytic
processing (OLAP) through fast healthcare interoperability resource (FHIR) application
programming interfaces (APIs). Also, many researchers provide IoT sensors as
eHealth connected devices connected with EHR in hospital information systems
(HIS), collected into a proper medical format (HL7 or FHIR) to make certain the
data is structured and easy to understand [
        <xref ref-type="bibr" rid="ref9">9</xref>
        ].
      </p>
      <p>
        Prados-Suárez et al. propose the use of EHR aggregator as middleware
between systems that can incorporate several sources giving unified access following
the FAIR (Findability, Accessibility, Interoperability and Reusability) principles.
That provides translation between standards and of systems to any standard,
including an integration layer acting as a single access point and offering a unified view
of intended data sources and providing data reusability [
        <xref ref-type="bibr" rid="ref10">10</xref>
        ]. The knowledge-driven
framework in the biomedical domain, able to transform disparate data into
knowledge for clinicians and data practitioners helping in the complex tasks of extracting
valuable knowledge from heterogeneous datasets is described in [
        <xref ref-type="bibr" rid="ref11">11</xref>
        ]. This
framework can show the potential for uncovering patterns that can enable the explanation
of treatment interactions and patient characterization [
        <xref ref-type="bibr" rid="ref11">11</xref>
        ].
      </p>
      <p>
        We have to mention the efforts of tethered PHR that seeks to achieve
interoperability by using open-source standards, achieving structural and semantic
interoperability, presented as prototyped mobile PHR with HL7 FHIR standard
implemented as well as SNOMED for captured data [
        <xref ref-type="bibr" rid="ref12">12</xref>
        ].
      </p>
      <p>
        Warner and Levy consider several emerging paradigms for integration
including non-standardized efforts between individual institutions and genomic
testing laboratories [
        <xref ref-type="bibr" rid="ref13">13</xref>
        ]. According to their research, cancer genomic
information integration into EHRs could be beneficial for patient-centered care,
especially when machine learning algorithms and CDS software is used for cancer
genomic-EHR integration and clinicians to be more inclined to let the genomic
information in their patients’ EHRs better guide the decisions they make if it is
well integrated.
      </p>
      <p>
        Several EU projects focus healthcare data integration on the patient-centric
level, providing data integration through PHR where the patient is the data owner
[
        <xref ref-type="bibr" rid="ref14">14</xref>
        ]. Many security issues are considered from the aspect of the patient and living
country of the patient [
        <xref ref-type="bibr" rid="ref15">15</xref>
        ]. So, the proposed model of the integrated healthcare
system has to be cloud-based, cross-border and based on the PHR with an
ehealth strategy. The main point is that data collection is possible to be done in a
hospital, out of hospitals and HIS and perhaps it cannot be connected with EHR
and country of living. The demands for this concept are increasing the e-health
and health digital literacy in order to support the national and local medical and
healthcare authorities [
        <xref ref-type="bibr" rid="ref14 ref16">14, 16</xref>
        ].
      </p>
      <p>Some authors think that healthcare data integration has to be wider and has
to provide wider data integration, not only for data analysis and healthcare
decision making. An integration of healthcare data, medical, omics, sensors data as
well as exposome data to provide data for prediction of the influence of health of
environmental, social, stress factors to risk to health assessment was proposed in
[17] and [18].
3</p>
    </sec>
    <sec id="sec-3">
      <title>Prerequisites for cloud-based PHR concept implementation</title>
      <p>The shifting priorities towards digital health care forced the need to use digital
technologies in the healthcare sector and set a secure, standard method for
crossborder healthcare data exchange.</p>
      <p>The project Cross4all addresses the e-health challenges in the cross-border
area, taking into consideration the problems of creating the PHR for patients from
two national healthcare systems where the patient is a data owner.</p>
      <p>
        The proposed architecture is cloud-based and distributed, in order to support
data collection from different types of sources and collected in a different way
such as patient’ healthcare data, medical practitioner data, sometimes collected
from biomedical devices, sensors for measuring vital signs of life, many times
collected from remote patients, collected from the disabled population, children
and elderly people. The central point of the system is a Cross4all application
server, as a part of an integrated e-health cloud system, connected with a central
Authentication/Authorization server with many security levels [
        <xref ref-type="bibr" rid="ref16">16</xref>
        ]. The
authentication layer is designed using the keycloack server. When authentication and
authorization are completed, the user will receive an authenticated token. It can
be used to access the API endpoints and then the PHR data. The PHR data is
stored in a graph database [19]. Data protection and encryption are described in
[20]. The cloud-based e-prescription and e-referral systems are part of the main
Cross4all system.
      </p>
      <p>The patient’s data from the two countries are split according to the patient’s
country of living. This concept is used because of the different patient data
protection laws in two Cross4all participant countries as well as different ownership
concepts of the patient data system.</p>
      <p>Medical devices such as oximeter, glucometer, spirometer, blood pressure
meter, stethoscope, ACG, thermometer and weigh scale are available for doctors.
Also, blood pressure meter, thermometer, oximeter and glucometer are available
to patients who need them. All medical devices are equipped with Bluetooth which
allows machine-to-machine communication. The IoMT infrastructure, combines
all these medical devices and software applications which communicate with
PHR and other health systems in both cross-border countries and manage the
patient’s treatment in a substantially improved manner. The patient’s quality-of-life
could increase with minimized doctor’s office time or could receive appropriate
health treatment in a cross-border country when he allows permission to his PHR
to the doctor in the cross-border country.</p>
      <p>The applications have a particular focus on serving the needs of the elderly
and people with disabilities [18] and socially/geographically isolated individuals.
The applications include multi-language support.</p>
      <p>Paired with mobile applications, collected data such as blood pressure,
temperature, oxygen saturation, concentration of glucose in the blood, the volume
of air inspired and expired by the lungs and weight or mass, are uploaded in real
time in the patient’s PHR. The collected data with the consent of the patient is
shared with the patient’s doctors in order to better surveil diseases and track and
prevent chronic illnesses. The capabilities of data collected from medical devices
are to improve the patient’s health service, more accurate diagnoses, fewer
mistakes and lower costs of care.</p>
      <p>The prerequisites for the project implementation include increasing the
participants’ e-health and healthcare digital competences. For this reasons,
educational material for this purpose was created and posted on an e-learning platform
for increasing the population healthcare digital and e-health literacy, taking into
consideration the needs of disabled peoples, the elderly population and children.
It is a free platform accessible for everywhere on disposal to the population with
many video materials, presentations and brochures that have to support the
project aim of increasing the population e-health and digital health literacy [21].
4</p>
    </sec>
    <sec id="sec-4">
      <title>Cloud-Based PHR implementation challenges</title>
      <p>The Cross4all project ecosystem consisted of the four integrated and
interconnected components: a Web portal and connected mobile application
for citizens; an eLearning module for citizens, which is aimed to improve their
health and digital health literacy; PHR and connected mobile app for citizens; and
interfaces for connecting external third-party systems to the project’s PHR, such
as national e-prescription and e-referral systems, or private telecare systems or
EHRs, enabled the data recorded in the systems be automatically (i.e., easily and
free of error) imported to the PHR owners.</p>
      <p>The implemented PHR solution is different from past efforts to integrate
existing eHealth systems and sources of patient data in two key aspects. First,
the users’ data, held and shared, is not restricted only to medical or
diseaserelated data created in the health institution to which the user is connected. It
may well include information beyond their medical history, such as information
related to maintaining a healthy life, such as lifestyle and living conditions,
altogether forming a more holistic representation of the person’s health lifecycle,
covering all kinds of physical, psychological, and social aspects, as shown in
Fig. 1. Secondly, in this PHR-based approach, the records stored are intended
to be fully owned and controlled by the user (patient) himself. In this way, it
lies upon the user alone to decide who, when and for how long, will be granted
access to what information and in which form or level of detail, as shown in
Fig. 2.</p>
      <p>The data and records of an individual in the project’s model, being manually
entered (Fig. 3) or automatically imported from a series of connected, authorized
by the user, health providers and systems, are completely independent of
thirdparty entities and are not meant to replace, under any circumstances, the official
records of other source providers.</p>
      <p>Despite the opportunities and benefits, there were many challenges during
the pilot project. The implementation of such a system requires users to have a
higher level of e-health and digital healthcare literacy. Some of the patients,
especially the elderly ones, usually have a low level of digital literacy and have to be
educated for this purpose. There is a lack of awareness and confidence in e-health
solutions among patients. Also, some of the medical staff is not open to the idea
of technological implementation. Because the EHR system is not fit at all into
the existing workflow, physicians find it difficult to adapt to it and it needs time
to overcome these obstacles. Moreover, healthcare professionals are supposed to
provide help to a big number of patients in a given time frame, which is
problematic when they have to use new solutions which they are not familiar with. From a
technical side, interoperability is one of the challenges. It is also important for the
system to enable the transfer of information among multiple providers, enabling
different EHR systems or software to exchange information.</p>
      <p>Taking these difficulties into consideration all mobile applications and PHR
are developed to be intuitive and easy to use, they are implemented with
principles for user interfaces design [22, 23], as shown in Fig. 4. Moreover, during
the design and development of PHR and mobile applications, a wide range of
opportunities for people with different preferences as well as older people and
people with different disabilities are provided.</p>
      <p>Overcoming the difficulties that medical personnel are faced with was
achieved easier with training about the new workflow and mobile applications,
using tutorials and providing technical support when needed during the pilot
project.</p>
      <p>The implementation of these solutions in everyday activity requires
additional efforts such as health professionals to be relieved of at least some of their
work until they become more familiar with using the system. Additionally, it is
necessary to facilitate cross-border data flow to take advantage of cross-border
data services. Also, it is important to emphasize the fact that the EHR system has
a high level of security of patient data, to increase the patients’ confidence.
5</p>
    </sec>
    <sec id="sec-5">
      <title>Conclusion</title>
      <p>Using the patient’s centric PHR concept, taking into account the legal regulations
of each of the countries for the patients’ PHR data, as well protection and
standardization of data exchange give a big advantage in existing and new
crossborder data services. The increased security implementations result in improved
user acceptance of this concept and the full exploitation of their advantages.
Implementation of this complex project demands efforts for increasing the
participants and population e-health and digital health competences. For this
reason, the e-learning platform for increasing digital health literacy as well as
e-health literacy was created. The platform was chosen according to WCAG
criteria that provide access for all, including disabled, elderly peoples and
children.</p>
      <p>The implementation of the project includes a cloud web-based PHR system
for a patient that has to aggregate all patient’s data including data from wearables,
biomedical data, medical and healthcare sensors data, patient’s e-prescription and
e-referral data and data from environmental sources. Also, social media and other
natural resources taken as exposome data that influence patient health can be used
for health risk assessment as well as all PDF and DICOM data that can be stored
by the patient. The whole concept used for the project implementation defines
couples of roles in the system that are defined and responsibilities that the owner
of data has for their data. The patient as an owner can grant access to their PHR
to the medical practitioners’ temporary to provide evidence-based healthcare in
the era of increasing mobility of the patients. All data are saved in a cloud
environment and the patient can have them with him everywhere. The patient and the
medical practitioners or specialists can input data in a patient’s PHR or acquire
from medical sensors according to IoMT concept, providing evidence-based
medicine for the patient. The patient also can input their medical and healthcare
data, providing scans from HIS data, lab’s data or acquiring data from wearables
as sensors for monitoring of vital signs of life. Connected with their PHR, the
patient and granted medical practitioners can use the exposome data to connect the
patient’s living place, the influence of environmental factors for patient’s living
condition adjustment and withdrawing some conclusion about the health
condition of living place.</p>
      <p>The implementation challenges and obstacles described in this paper can
help to clarify some implementation points and demands intended for a wider
community when such a project has to be implemented as well as when some
other IoMT devices have to be accepted in the implementation. This project has
also shown the need for increasing digital health literacy, e-health and m-health
literacy in the era of IoMT.</p>
      <p>In future work, we have to work on defining od some exposome data for
some chronic disease and quantify or assess the risk for this disease from
environmental pollutant, location’s health factors or other stressors that influence this
disease.
6</p>
    </sec>
    <sec id="sec-6">
      <title>Acknowledgement</title>
      <p>Part of the work presented in this paper has been carried out in the framework
of the project “Cross-border initiative for integrated health and social services
promoting safe ageing, early prevention and independent living for all
(Cross4all)”, which is implemented in the context of the INTERREG IPA Cross
Border Cooperation Programme CCI 2014 TC 16 I5CB 009 and co-funded by the
European Union and national funds of the participating countries.
17. Savoska S., Ristevski B., Blazheska-Tabakovska N., Jolevski I. Towards Integration Exposome
Data and Personal Health Records in the Age of IoT. In: 11th ICT Innovations Conference
2019, 17-19 October, Ohrid, Republic of Macedonia.pp.237-246, 2019.
18. Barouki R., Audouze K., Coumoul X., Demenais F., Gauguier D., Integration of the human
exposome with the human genome to advance medicine. Biochimie, Elsevier,2018, 152,
pp.155158. 10.1016/j.biochi.2018.06.023. hal-02196327
19. V. Kilintzis, I. Chouvarda, N. Beredimas, P. Natsiavas, and N. Maglaveras, “Supporting
integrated care with a flexible data management framework built upon Linked Data, HL7 FHIR and
ontologies,” J. Biomed. Inform., vol. 94, 2019.
20. Savoska S., Jolevski I., Ristevski B., Blazheska-Tabakovska N., Bocevska A., Jakimovski
B., Chorbev I., Kilintzis V. Design of Cross Border Healthcare Integrated System and its
Privacy and Security Issues. Computer and Communications Engineering, 13 (2). pp. 58-63. ISSN
1314-2291
21. Blazheska-Tabakovska N., Ristevski B., Savoska S. and Bocevska A. Learning Management
Systemsas Platforms for Increasing the Digital and Health Literacy, CEBT 2019: Proceedings
of the 2019 3rd International Conference on E-Education, E-Business and
E-TechnologyAugust 2019 Pages 33–37 https://doi.org/10.1145/3355166.3355176
22. Blazheska-Tabakovska, N., Savoska, S., Ristevski, B., Jolevski, I. and Gruevski, D. Web
Content Accessibility for People with Cognitive Disabilities, Proceedings of the IX International
Conference on Applied Internet and Information Technologies AIIT 2019. October 2019,
Zrenjanin, Serbia
23. Veljanovska, K. Blazeska Tabakovska, N., Ristevski, B. and Savoska, S. User Interface for
elearning Platform for Users with Disability, Proceedings of the ISGT 2020 Information Systems
and Grid Technologies, May 29 – 30 Sofia, Bulgaria
24. ATutor Cross4all page: http://atutor.cross4all.uklo.edu.mk/login.php, Accessed 15.3.2021</p>
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