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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>The Use of Big Data in Medicine and Public Health Policy-Making: Opportunities and Challenges</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Ioannis Patias</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Vasil Georgiev</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Faculty of Mathematics and Informatics, University of Sofia St. Kliment Ohridski 5 James Bourchier Blvd.</institution>
          ,
          <addr-line>1164, Sofia</addr-line>
          ,
          <country country="BG">Bulgaria $%</country>
        </aff>
      </contrib-group>
      <fpage>7</fpage>
      <lpage>13</lpage>
      <abstract>
        <p>This paper presents the problem of small outcomes compared to the investment in large scale IT projects. Focus was given in the application of big data in health sector, where the new element, enhancing the problem, comes from the incorporation of new forms of patient generated data. Proposed were processes aiming on the one hand to underline that apart of the importance of patients' involvement, also important is the involvement of all the other stakeholders. This will both make data collection easier and better, and turn data into actionable information. Finally concrete interventions in the direction of Big Data usage in Health sector are here proposed, which will help in enabling new operating and business models.</p>
      </abstract>
      <kwd-group>
        <kwd>big data</kwd>
        <kwd>public health policy-making</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1 Introduction</title>
      <p>In many sectors, when implementing large scale IT projects, the outcomes seem
small compared to the investments. It makes no difference in the health care
sector. Medical professionals claim that with the currently used IT systems they
are wasting their time, as they are hard to use and even more they interfere their
interactions with patients. In addition, healthcare institutions get more losses than
gains, as they have to deal with many issues when integrating new IT systems
into their operations. Finally, any efforts in the direction of persuading health
institutions to share information continue to lag, due to communication and
compatibility issues, and legal limitations, resulting in data being useless for the
public health policy-making.</p>
      <p>
        Getting an inside look of the problem we may see that the currently used
IT systems focus majorly on electronic registers, which can improve billing and
reimbursement procedures [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. Smaller part of the applications is focused on the
improvement of the services provided to the patients, like the order entry – results
provision cycle [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. Even less applications, get deeper focusing on data analytics
for medical professionals and public health decision makers [
        <xref ref-type="bibr" rid="ref3 ref4">3, 4</xref>
        ]. Therefore, we
have improvements in the operations, at some level, but we do not get one level
below to improve the processes [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ].
      </p>
      <p>
        However, we see some industries use technology better than others do, and
labor productivity statistics reflect that. In the case of U.S., we see that the health
care has been growing faster, as an industry, than the overall economy. However,
since the number of health care workers has been rapidly increasing, and the use
of information technology has lagged, productivity growth has been minimal [
        <xref ref-type="bibr" rid="ref6">6</xref>
        ].
      </p>
      <p>The idea of this paper is to explore, whether big data can help in the
direction of improving IT systems, and their use in the health sector, so they can better
serve the medical professionals and more specific the public health policy makers.
Even more to propose proper interventions, which can contribute in overcoming
the current obstacles, and in introducing new business and operation models,
including multidisciplinary knowledge and teams.</p>
    </sec>
    <sec id="sec-2">
      <title>2 Big Data value in the health sector</title>
      <p>
        However, let us first define the use of big data in the health care sector. Until
now, the focus is on public health policy-making, clinical trials and research, and
health services provision improvement. The data used for the purpose are
electronic health records (EHRs), electronic patient reported outcomes (ePROs),
genomics and imaging data. There are many examples of successfully implemented
systems, but all of them are related to concrete institutions and deal with concrete
medical cases [
        <xref ref-type="bibr" rid="ref10 ref11 ref8">8, 10, 11</xref>
        ].
      </p>
      <p>
        Supporting the above, we may see [
        <xref ref-type="bibr" rid="ref12">12</xref>
        ] where the developments in the health
care sector, majorly based on Big Data analytics are focused on improving the
public health policies, the clinical research and the care provided to patients.
      </p>
      <p>The difference comes since until recently data like EHRs, and ePROSs were
included. The new element comes from the incorporation of new forms of patient
generated data. These forms include both physiological but also psychometric
data. Data collected real-time, and directly through sensor devices or data
generated online, as patients’ comments or posts in social networking tools online.
We see mobile technologies and sensor devices facilitating the development of
new models supporting online methods of health monitoring. The focus is on
recording and analyzing big volumes of physiological and psychometric data, now
directly collected from patients.</p>
      <p>
        However, although we see many successful projects, applying different
technologies in healthcare in analyzing Big Data, there is a lag between those projects
and their real application in clinical practice. We have promising results in
clinical research, as data-driven hypothesis generation and testing, or as identification
of relationships and results based on heterogeneous data sets of genomic or
environmental data and patient health records [
        <xref ref-type="bibr" rid="ref13">13</xref>
        ]. However, in the everyday clinical
practice the overall result is becoming unclear. We have in place clinical decision
support systems, and tools. We also have advanced diagnostic systems and tools
and other types of health information systems, which are improving the patients’
experiences and the overall quality of the provided health and care services.
      </p>
      <p>The aim of this paper was to review the Big Data and data-driven systems
and tools targeting patients, doctors and public health policy makers as their
immediate beneficiaries, and identify actions focused on how Big Data actually can
help to improve the effectiveness of those tools and systems used for the
promotion of health in primary and secondary healthcare.</p>
    </sec>
    <sec id="sec-3">
      <title>3 Improving the processes</title>
      <p>Having in mind the above, both as example of best practices, but also as
divided opinion of the medical professionals, and health policy decision makers,
regarding the effectiveness of big data in health care, we propose to get one level
below and try to define the operations. Having the operations defined we may
further propose interventions on a per-process basis.</p>
      <p>The scope of the proposed processes is on the one hand to underline that
apart of the importance of patients’ involvement, it is also important the
involvement of all the other stakeholders. They are all part of the big data value chain in
medicine and public health policy-making. We need to include from the medical
professionals to the public health policy-makers, but also IT and data specialists,
the public administration, etc.</p>
      <p>
        The European Commission (EC), Directorate-General for Health and Food
Safety, Directorate B — Health systems, medical products and innovation, Unit
B.3 — Cross-border Healthcare, e-Health [
        <xref ref-type="bibr" rid="ref7">7</xref>
        ], has been active. It has presented
policy recommendations in the respective Final Report as results for a Study on
Big Data in Public Health, Telemedicine and Healthcare. Here we refine those
recommendations as an actionable plan for the patients, doctors and public health
policy makers, supported by IT and data specialists, the public administration.
      </p>
      <p>The scope of the actionable plan is to provide with suggestions to the public
health policy makers on how to:
• utilize the strengths and exploit the opportunities of Big Data for Public</p>
      <p>Health without compromising privacy or safety of citizens;
• use Big Data in Health not as a goal in itself, but as a tool to reach certain
purposes that benefit the patient and the public;
• protect current ethical standards and not let be compromised for potential
benefits of Big Data; and
• include as more as possible stakeholders in the implementation of the
proposed recommendations and in the production of future recommendations on
Big Data in Health.</p>
    </sec>
    <sec id="sec-4">
      <title>4 Interventions</title>
      <p>
        Concrete interventions in the direction of Big Data usage in Health sector
are here proposed. They are formulated as recommendations in different aspects,
which will enable new business models. The following list summarizes the
interventions:
1. raise awareness: aiming in the development and the implementation of a
communication strategy, which would help increasing the added value of Big Data
in Health and encouraging a positive attitude towards Big Data in Health.
2. provide education and training: focus on the human capital and increase the
workforce capabilities in utilizing the Big Data potential in Health. There is a
huge need for increasing the digital literacy of the healthcare professionals.
3. secure the data sources: the quality and safety of the existing data sources
is the first priority, but also the need of expansion, and identification of new
data sources. An excellent example in this direction must be mentioned the
experience, and best practice of the act on secondary use of health and social
care data. This act opens up new possibilities and streamlines usage health
and social care data. On March 13th 2019, after almost four years of
preparatory work, the Finnish Parliament approved the Act on the Secondary Use of
Health and Social Data [
        <xref ref-type="bibr" rid="ref14">14</xref>
        ].
4. use open data, and promote sharing of data: by promoting open use and
sharing of Big Data, but always taking care not to compromise privacy and
confidentiality rights of the patients. Here we can mention as best practice the
Global Alliance for Genomics and Health (GA4GH) white paper [
        <xref ref-type="bibr" rid="ref15">15</xref>
        ].
5. focused on target-oriented Big Data application: Big Data analytics in health
should be based on concrete needs and interests of stakeholders for
evidencebased decision-making [
        <xref ref-type="bibr" rid="ref16">16</xref>
        ]. The trustworthy and reliable information
production needs to address the related to the application of Big Data in Health
concerns. Best practice in this direction is the Ethics guidelines for trustworthy AI
[
        <xref ref-type="bibr" rid="ref17">17</xref>
        ].
6. improve data analysis methods: by identifying potential for Big Data analysis
and analytical methods improvements.
7. develop standards: helping to improve interoperability at all levels, and
enhance Big Data applications in health.
8. further support legal, and medical ethics initiatives: by clarifying existing
already regulations and legal frameworks, and by adopting new alignment
instruments for medical ethics [
        <xref ref-type="bibr" rid="ref18">18</xref>
        ]. Best practice in this direction should be
considered the GDPR, Regulation 2016/67915, which aims at strengthening
the rights of natural persons, and represents the foundation for EU data
protection rules.
5
      </p>
    </sec>
    <sec id="sec-5">
      <title>Conclusions</title>
      <p>The problem of small outcomes compared to the investment in large scale IT
projects was presented as it appears in many sectors. Especially in the application
of big data in health sector, the new element enhancing the problem comes from
the incorporation of new forms of patient generated data. These forms include
both physiological but also psychometric data. Data collected real-time, and
directly through sensor devices or data generated online, as patients’ comments or
posts in social networking tools online. Proposed were processes aiming on the
one hand to underline that apart of the importance of patients’ involvement, it is
also important the involvement of all the other stakeholders. This will both make
data collection easier and better, and turn data into actionable information.
Finally concrete interventions in the direction of Big Data usage in Health sector are
here proposed, which will help in enabling new operating and business models.</p>
    </sec>
    <sec id="sec-6">
      <title>Acknowledgements</title>
      <p>This paper is prepared with the support of GloBIG: cloud integration model
platform with hybrid massive parallelism and its application for analysis and
automated semantic enrichment of large collections of heterogeneous data contract
number: DN 02/9-17.12.2016г., and the scientific project, under the National
Scientific Program “е-Health in Bulgaria”, contract number: D01-200/16.11.2018</p>
    </sec>
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