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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Reference Model for Health Data Security Management Supported in a Blockchain Platform</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>r Espíritu</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Christi</string-name>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Universidad Peruana de Ciencias Aplicadas</institution>
          ,
          <addr-line>Lima</addr-line>
          ,
          <country country="PE">Peru</country>
        </aff>
      </contrib-group>
      <abstract>
        <p>Several problems in health care come from the complex network of intermediaries. Currently, medical health data is fragmented and isolated, there are communication delays and workflow tools are different due to lack of interoperability, which negatively affects research and health services. For these reasons, health entities and their patients need to securely protect their data. However, for the privacy of patients, the danger of having such information on the network and due to the vulnerability of traditional authentication systems, a reference model is proposed to manage the health data security based on Blockchain. Blockchain allows access to complete medical records that are stored in fragmented systems anonymously and securely. Our reference model uses the concepts of an information security management system such as: policies, risks and controls. This allow private or public entities in the health sector to implement Blockchain. On the other hand, our reference model was developed by researching and comparing existing Blockchain platforms in the health sector, with the purpose of guiding qualified information security personnel when they decide to implement Blockchain in a health sector organization.</p>
      </abstract>
      <kwd-group>
        <kwd>Reference Model</kwd>
        <kwd>Blockchain</kwd>
        <kwd>Healthcare</kwd>
        <kwd>Data Management</kwd>
        <kwd>ISMS</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>-</title>
      <p>
        The health industry is one of the largest industries in the world, since it consumes more
than 10% of the gross domestic product (GDP) of the most economically developed
countries with a high standard of living [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. In addition, the process of allowing the
exchange of data between multiple parties, although it is beneficial for the patient, still
lacks transparency and control. Patients have expressed concern about the possibility
of their medical data being used by for-profit entities [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. Patient data is dispersed in
different entities of the health industry known as data silos; data sharing is prone to a
multilevel permit control process [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. Because of this, many times, crucial data is not
accessible and is not available at the time of an emergency.
      </p>
      <p>Copyright c 2020 for this paper by its authors. Use permitted under Creative Commons</p>
      <p>
        Blockchain can solve this problem with the exchange of health information by acting
as a secure decentralized database. Blockchain is a revolutionary technology that can
help solve the challenges of medical care by providing security and trust. Access to a
patient's medical history can be enabled for all health care providers prior to patient
registration and authorization. The access control system in Blockchain puts patients in
control of their data; consent and access rights may be granted to third parties to a subset
of your medical records. It is possible to write custom laws and agreements through
smart contracts which are equivalent to real-world contracts [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ].
      </p>
      <p>Smart contracts can be used in various processes within medical care, including
billing and insurance, which helps automate the process and reduce costs. To unify the
compression of Blockchain technology and its security, a reference model is proposed
that allows us to provide a series of controls based on possible risks that may occur
within the Blockchain platform and affect the privacy of patient health data. For this
reason, we investigate the different Blockchain platforms for the health sector where it
was decided what properties we consider for our analysis. We will use the information
collected and analyze the similarities and differences between the platforms.
2
2.1</p>
    </sec>
    <sec id="sec-2">
      <title>Literature Review</title>
      <sec id="sec-2-1">
        <title>Research protocol</title>
        <p>
          This research is carried out from the perspective of health care to build our reference
model and, therefore, we are considering the following property. Platforms: We are
considering Blockchain technology implementations that introduce different
approaches to privacy and smart contracts [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ].
 Public Blockchain: All records are visible to the user and everyone can participate
in the consensus process [
          <xref ref-type="bibr" rid="ref3">3</xref>
          ].
 Private Blockchain: It has centralized permission for a governing organization [
          <xref ref-type="bibr" rid="ref3">3</xref>
          ].
2.2
        </p>
      </sec>
      <sec id="sec-2-2">
        <title>Selected Blockchain platforms</title>
        <p>Blockchain technology platforms can be divided into two groups, as illustrated in Table
1. For our study, we have selected a Blockchain platform from each group.</p>
        <p>
          They can be characterized as follows:
MediChain: It is a Blockchain solution for the storage and distribution of medical data
that allows patients to have control over their own medical information [
          <xref ref-type="bibr" rid="ref7">7</xref>
          ].
 Advantage: It allows the exchange of medical records between the patient and their
doctor, as well as research institutions protecting the confidentiality and security of
the data.
 Disadvantage: It is open source and does not offer a backup system in case of data
loss, it does not allow to work with pharmaceutical entities.
        </p>
        <p>
          MediBloc: It is the combination of a social need with a technological enabler, it is a
system that prioritizes patient data, providing a transparent and accessible view of the
medical history [
          <xref ref-type="bibr" rid="ref6">6</xref>
          ].
 Advantage: It is associated with the use of "smart contracts", which allow the
exchange of information through an intermediary who oversees executing complex
transactions.
 Disadvantage: It is a network without permission and the user pays a 10%
commission when exchanging their health information.
        </p>
        <p>
          Patientory: It is a distributed application based on Cybersecurity Blockchain that
provides users with access to their health data. Creates smart contracts that can be executed
in relation to the continuous cycle of medical and patient care. Centralize all patient
medical data in one place to manage, share and track medical care [
          <xref ref-type="bibr" rid="ref4">4</xref>
          ].
 Advantage: It helps healthcare organizations create personalized smart contracts for
those healthcare organizations that adopt and use the Patientory Blockchain network.
 Disadvantage: It works as a private network and is not open source, uses proprietary
algorithms and does not allow modifications to the source code.
        </p>
        <p>
          Medicalchain: It allows doctors, hospitals, laboratories, pharmacists and health
insurers to request permission to access a patient's record-to-record transactions in a
distributed ledger [
          <xref ref-type="bibr" rid="ref5">5</xref>
          ].
 Advantages: Provides the patient with full access and control over their data, ability
to provide different levels of access to various users, assigning a set of access
permissions and designating who can consult and write data on their Blockchain.
 Disadvantage: It is a private Blockchain that is not open source and does not allow
external developers to show their applications within the ecosystem.
3.1
        </p>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>Theoretical Foundation</title>
      <sec id="sec-3-1">
        <title>Reference model:</title>
        <p>
          Reference models are reusable representations of abstract knowledge for a given
application domain. Also, they are relevant representations for a purpose of an information
system designed through a construction process. They provide a useful means to reduce
the information modeling effort. They are developed with the objective of being reused
for different scenarios of similar applications and are used as a starting point for the
construction of specific project models [
          <xref ref-type="bibr" rid="ref8">8</xref>
          ].
3.2
        </p>
      </sec>
      <sec id="sec-3-2">
        <title>Blockchain:</title>
        <p>
          It is one of the technologies behind Bitcoin, an open peer-to-peer value transfer network
(p2p). Cryptocurrencies are analogous to money currencies such as the USD or the EUR
that facilitate the exchange of value but use cryptographic protocols as the basis of
governance instead of relying on a central authority such as banks [
          <xref ref-type="bibr" rid="ref9">9</xref>
          ]. In Blockchain,
a transaction represents a change of state. When a new transaction is created, it is
transmitted to the network where a mining node (computer) collects the transaction and
composes a block by combining one or more transactions and broadcasts the block to
the network [
          <xref ref-type="bibr" rid="ref10">10</xref>
          ].
3.3
        </p>
      </sec>
      <sec id="sec-3-3">
        <title>Smart contracts:</title>
        <p>
          A smart contract represents a piece of self-executing, self-verifiable and
tamper-resistant code with a programmable programming application logic that resides and runs
on Blockchain [
          <xref ref-type="bibr" rid="ref3">3</xref>
          ]. Formalizes transaction rules and relationships between entities and
assets in Blockchain and provides the flexibility to write the logic of the custom
application that becomes a law imposed by the Blockchain itself without relying on trusted
intermediaries [
          <xref ref-type="bibr" rid="ref11">11</xref>
          ]. As an example, Ethereum it is a platform based on smart contracts
[
          <xref ref-type="bibr" rid="ref12">12</xref>
          ].
3.4
        </p>
      </sec>
      <sec id="sec-3-4">
        <title>Health data management:</title>
        <p>
          The management of health data that includes storage, access control and data exchange
is an important aspect of the health industry. Proper management of health data
improves results and allows a comprehensive view of patients, personalized treatments
and efficient communication. Confidence problems and lack of profit incentives are the
main obstacles to the exchange of health data [
          <xref ref-type="bibr" rid="ref13">13</xref>
          ]. Blockchain technology can solve
both problems by acting as a layer of trust, introducing profit mechanisms such as
tokens (digital assets) that are used as a reward [
          <xref ref-type="bibr" rid="ref12">12</xref>
          ]. With the Blockchain incentive and
trust structure enabled, there is a promise of a global health information exchange [
          <xref ref-type="bibr" rid="ref12">12</xref>
          ].
However, by establishing a series of guidelines focused on an information security
management system based on ISO / IEC 27799: 2016, the exchange of health data will
be safer compared to the traditional process of medical history of a health entity.
4.1
        </p>
      </sec>
    </sec>
    <sec id="sec-4">
      <title>Case Study</title>
      <sec id="sec-4-1">
        <title>Organization:</title>
        <p>The model was implemented in a clinic specialized in providing health care services
for institutions and companies (public or private), has a large team of specialized
professionals, with extensive experience in health and medicine. The local clinic did not
carry out risk management on a continuous basis, due to the time it may require and
because it did not have a specialized information security staff to carry it out.
4.2</p>
      </sec>
      <sec id="sec-4-2">
        <title>Implementation:</title>
        <p>The implementation of the reference model is carried out in the medical history
registration process, since it is the central process of the clinic, in which all information
related to this must be protected. The selected work team is composed of the process
owner, the head and coordinator of the systems area, as well as the authors of this
article.</p>
        <p>Phase 1: Validation of the risk matrix: We need the clinic information and IT
information as inputs. Following our proposed model, in phase 1, for the traditional scenario,
ten risks were found, classifying them as two High risks, eight Medium risks and zero
Low risks. This meant that there are certain deficiencies on the part of the systems area,
as they did not contemplate such risks that could affect the integrity of the clinic. Once
the traditional system scenario has been analyzed, the risk matrix prepared based on the
analysis that was made using the Ethereum platform consisting of a decentralized
Blockchain is shown, finding a series of risks that could occur outside the Blockchain
where a total was found. Of 11 risks classifying them as 0 High risks, 8 Medium risks
and 3 Low risks.</p>
        <p>This means that there is still a risk on users who have to adapt to use this technology,
since within the Blockchain the information is secure; the problem comes when it is
outside of this. Finally, the risk exposure of the traditional system is compared to a
scenario using Blockchain technology. For this, a heat map was made where the codes
of the risks found are placed and classified according to the result obtained.</p>
        <p>The results obtained were calculated based on the sum of the metrics of the risks found
and classified on the maximum metric (90). Obtaining a risk level of 67% (Fig. 1.) in a
traditional system scenario and 41% (Fig. 2.) in a scenario where Blockchain technology
is used. concluding that there is a higher risk exposure in a traditional system, while
using Blockchain technology the risk exposure is reduced by 26%.</p>
      </sec>
      <sec id="sec-4-3">
        <title>Phase 2: SoA Validation (Statement of Applicability): Once the results of the assess</title>
        <p>ment of the identified risks have been obtained, the SoA template is used as a reference
for the implementation of information protection measures, as well as to verify that no
necessary security measures are being set aside.</p>
        <p>They had not been considered inside the clinic. Next, we will see the results obtained
in the traditional system scenario where the validation of this document was carried out.</p>
        <p>It can be seen that the vast majority of the sections of controls their level of
compliance is below 20%, which indicates that there is a large breach of information security
quite exposed. The average result obtained gives us 11% compliance, this means that
there are no controls established within the clinic to ensure and protect the information
of their patients against cyber-attacks.</p>
        <p>Once the results on compliance with SoA document controls were analyzed, the same
controls were validated, but this time on stage using Blockchain technology. Next, we
will see the results obtained using Blockchain technology in any health sector
organization.</p>
        <p>Most controls meet more than 20% of the criteria necessary to carry out proper
management information security. As well, the average result obtained gives us a total of
44% compliance, this means that when using Blockchain technology, the controls
established within the clinic are more robust and meet the criteria necessary to carry out
a correct management of information security, in order to guarantee and protect patient
information against possible attacks.</p>
        <p>Once the analysis of both scenarios is completed, a graph is prepared with the results
obtained to make a comparison and see the compliance status for each of the sections
proposed in the SoA template. The results obtained indicate that there is a 33%
improvement in overall compliance when using Blockchain technology compared to a
clinic with a traditional system.</p>
      </sec>
      <sec id="sec-4-4">
        <title>Phase 3: Validation of asset inventory: The inventory of information assets was</title>
        <p>measured by the criticality obtained by its final classification level where the
confidentiality presented 9 high level, 16 medium level and 0 low level. On the part of the
integrity, 6 of high level, 11 of medium level and 8 of low level were presented. Finally,
I present 5 high level, 16 medium level and 4 low level availability.</p>
        <p>Finally, together with the total distribution by the classification of the levels and
turning it into a percentage, the following results were obtained: High Level = 32%,
Medium Level = 52%, Low Level = 16%. With these results we can conclude that the
highest percentage of classification is given by the average level, which indicates that
the information assets are mostly of medium to high importance for the clinic where
the classification of the inventory of information assets.
The model was validated at a local clinic (Lima, Peru) and compared in a simulation
scenario using Blockchain technology. In the results of the implementation of the
model, it is observed that the level of risks would be reduced by 26%, compliance with
the controls would increase by 33% when the proposed controls are applied in a
scenario with Blockchain.</p>
        <p>The proposed reference model will allow knowing the status of compliance with
policies and controls based on the ISO / IEC 27799: 2016 standard of any health center.
Based on the results obtained, the clinic was shown that it is ideal to have knowledge
about its risks, controls and assets that are the most critical and to consider a risk
analysis to make decisions about the safety of each of them.</p>
        <p>With the implementation of the reference model, the health centers will have a
detailed vision about the possible risks that could occur, avoiding legal problems such as
lawsuits imposed by patients or financial sanctions by the regulatory entity.</p>
        <p>The costs of implementing mitigating controls are high compared to using a
Blockchain technology that mostly minimizes security breaches. When using Blockchain
technology, a new risk appears which is: the use of the private key, consider that if a
user loses their private key, they automatically lose all their information stored in the
Blockchain.</p>
        <p>Our future plans regarding the research carried out is to be able to help hospitals and
clinics to choose the best Blockchain platform alternative, since at the end of the day
migrating the medical information of their patients to Blockchain will be a reality in the
future that benefit the health sector.</p>
      </sec>
    </sec>
  </body>
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            <surname>Yue</surname>
            ,
            <given-names>X.</given-names>
          </string-name>
          ,
          <string-name>
            <surname>Wang</surname>
            ,
            <given-names>H.</given-names>
          </string-name>
          ,
          <string-name>
            <surname>Jin</surname>
            ,
            <given-names>D.</given-names>
          </string-name>
          ,
          <string-name>
            <surname>Li</surname>
            ,
            <given-names>M.</given-names>
          </string-name>
          , &amp;
          <string-name>
            <surname>Jiang</surname>
            ,
            <given-names>W.</given-names>
          </string-name>
          (
          <year>2016</year>
          ).
          <article-title>Healthcare data gateways; found healthcare intelligence on blockchain with novel privacy risk control</article-title>
          .
          <source>Journal of medical systems</source>
          ,
          <volume>40</volume>
          (
          <issue>10</issue>
          ),
          <fpage>218</fpage>
          .
        </mixed-citation>
      </ref>
    </ref-list>
  </back>
</article>