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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Blockchain in the Logistics of Health Technologies</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Svetlin Georgiev</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Stamatios Priftis</string-name>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Evgeni Grigorov</string-name>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Department of Health Technology Assessment, Faculty of Public Health, Medical University - Sofia</institution>
          ,
          <country country="BG">Bulgaria</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, Medical University “Prof. Dr. Paraskev Stoyanov” - Varna</institution>
          ,
          <country country="BG">Bulgaria</country>
        </aff>
      </contrib-group>
      <fpage>189</fpage>
      <lpage>202</lpage>
      <abstract>
        <p>The article focuses on the practical significance of blockchain technology and its contributions to public health. The focus is on innovations in the sphere of logistics such as smart contracts and “Internet of things” that illustrate their contribution to achieving quality and transparent logistics of health technology management. The methodology of the article includes monitoring technological innovation in logistics. It is based on literary search, tracking development trends, and the importance of blockchain technology in various health care areas. Innovation in logistics finds its place and role in activities aimed at protecting public health. Blockchain contributes to increasing trust between health logistics and service providers, ensuring a secure production process and flexibility in the distribution chain.</p>
      </abstract>
      <kwd-group>
        <kwd>Blockchain</kwd>
        <kwd>Logistics</kwd>
        <kwd>Health Technologies</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>Introduction</title>
      <p>Blockchain is a fast-growing technology that has the potential to transform the
modern industry. As more and more entrepreneurs become aware of the possibility
of technology, it raises the question of what blockchain is, how it works, and where
it is applied. It is often associated with financial services and logistics but is also
relevant for all other industries. The numerous aspects of blockchain technology
in the healthcare sector are at the heart of this paper. The role of technology in
the implementation of processes in different healthcare fields and the logistics of
medical devices has been considered. Whatever the advantages, the approaches,
goals, and capabilities of the technology are still largely unknown. One of the
paper aims is to bring light to the practical significance of the blockchain and its
contributions to public health.</p>
      <p>This paper’s methodology is based on literary search, tracking development
trends, and the importance of the blockchain. Quality tools have been used for
data collection, including monitoring and analyzing public health activities, and
in particular logistical processes in the health sphere.</p>
      <p>Activities and methodologies were studied for various health activities –
medical logistics, health records, drug substance tracking, drug falsification,
goods transport and storage, clinical trials logistics, medical devices, health care
management, human resources, and so on. For each of the processes,
blockchain’s importance is analyzed to illustrate the optimal benefits of technology for
logistics processes.</p>
      <p>The subject of analysis in this article is the implementation and benefits of
blockchain technology in health logistics. The study looks at ways to optimize
healthcare logistics processes at different stages – from drug delivery and
distribution to clinical trials. Successful interpretation and integration of innovative
logistics approach in the sphere would make it easier for the public to access
adequate health care and improve the quality of the healthcare services offered.
Critical concepts in the search for survey data are blockchain, logistics, health
technologies, medical devices.
2</p>
    </sec>
    <sec id="sec-2">
      <title>Blockchain in practice</title>
      <p>
        Blockchain technology stores and shares information across networks between
users locating around the world. It was initially designed to manage the Bitcoin
crypto-currency. The goal is to protect and secure the ownership of digital
currencies in transactions [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ] through technology, ensuring a secure, transparent,
and reliable operating system.
      </p>
      <p>Blockchain innovation is a data recorder working with information from
financial transactions, transfers of goods, medical records. However, what
distinguishes blockchain from ordinary databases? An accounting book, for example,
is a document in which the actual transactions are recorded. Traditional paper
books include consecutive pages in which each line records a transaction. When
the page is complete, the process is repeated the next. The data for the operation
is available and correctly reflected but very easy to manipulate. The information
can easily be changed, lost, or misused.</p>
      <p>
        Each block is a peer-to-peer page. Each operation’s data is recorded in a
separate block, and the record is made using a time-tagged approach. When a block
is filled with data, a new one is created. Unlike traditional books, when the block
is complete, the system creates a hash value [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. A unidirectional mathematical
function serves to “fragment” a multitude of data. In other words, a variable-sized
text can be recreated as a strictly defined, corresponding text, called hash, hash
value, or digest [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ]. Thus, the recorded information exists in the form of a unique
code that is a random number generated by an algorithm based on the block’s
contents [
        <xref ref-type="bibr" rid="ref4">4</xref>
        ]. This hash value is recorded as the first record in the next created
block [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ].
      </p>
      <p>This process “connects” the blocks between them, from where the term
“blockchain” originates. If someone ever tries to change a record in a previous
block, the hash value will no longer match the entry in the next block, and the
change is considered invalid. In part, this is the mechanism by which blockchain
creates unchangeable records. In blockchains, the information is copied and
stored at multiple nodes (or computers) on a shared network. This leads to
creating a system in which data is stored in many places and subject to control and
transparency for all network participants, guaranteeing the integrity of personal
data. The system is decentralized. It imposes the rules that the participants have
access to, controlling the storage and verification of transaction data
(transactions). This avoids the problem of accumulating stocks of outdated data with no
practical value in the databases. In social blockchains (accessible to a broad user
table), anyone can create a node (enter information) or view available data.
However, in private block circuits, only users with access permissions can share and
view documented data. This can help solve the issues of confidentiality.</p>
      <sec id="sec-2-1">
        <title>2.1 Role of smart contracts</title>
        <p>
          Smart contracts are an essential and powerful tool provided by Blockchain
technology [
          <xref ref-type="bibr" rid="ref7">7</xref>
          ]. It can automatically receive information from various sources
(including internet sensors) and apply a program set of rules (if-then) with little
or no human intervention. Smart contracts work so that “if” certain conditions
(programmed in the smart code) exist, only “then” generates certain activities.
        </p>
        <p>Smart contracts can be used to automate different processes in a very flexible
and customizable way. They increase efficiency and reduce costs by removing
intermediaries and automating tasks that are typically executed manually. Smart
contracts can be used in health care, automation of logistics networks of
medicinal products and medical devices, and facilitating tracking distribution chains in
real terms.</p>
      </sec>
      <sec id="sec-2-2">
        <title>2.2 Internet of Things (IoT)</title>
        <p>The network of sensors – Internet of Things (IoT) can collect data, communicate
over the Internet or other systems, or take other action based on a predefined
set of conditions. For example, an IoT sensor can be placed on a container of
pharmaceuticals or medical devices and thus generate real-time location data of
the respective container. In a more sophisticated embodiment, sensor data may be
provided as smart contracts inputs. When the data shows and confirms that a packet
is delivered from side A to side B, smart contracts can be programmed to transfer
data directly to party B and trigger payment to party A without intermediaries.
This process supports the logistics of medical devices and medicines by reducing
the cost of intermediaries, shortening delivery times, shortening the documentary
procedure for picking up and accepting goods.</p>
      </sec>
      <sec id="sec-2-3">
        <title>2.3 Key benefits of blockchain technology</title>
        <p>
          Revolutionary technology has the potential to become a driving force for the
development of modern societies. In a World Economic Forum report released
in September 2015, 58% of respondents expect that by 2025, 10% of the global
gross domestic product will be held through the World Economic Forum
technology [
          <xref ref-type="bibr" rid="ref9">9</xref>
          ]. Therefore, it is not surprising that blockchain attracts investors who are
betting nearly half a billion dollars in 2015 [
          <xref ref-type="bibr" rid="ref10">10</xref>
          ], with the trend growing. Some of
the advantages of blockchain technology are listed below:
• Unmodifiable data – hash content records, the link between blocks, and
hash-tracking to a subsequent block, makes data unchangeable;
• Layout – by storing and controlling copies of data in multiple nodes
(blocks), single points of failure of the information are avoided, ensuring
its security;
• Decentralization – validation of transactions (operational activities)
through a trustworthy sharing mechanism between participants, prevents
the need for control of one (central) body;
• Transparency – Blockchain data is visible to all participating parties,
which can provide greater transparency of supply chains from point A to
point B;
• Security – the use of digital signatures through critical public
infrastructure (PKI) [
          <xref ref-type="bibr" rid="ref11">11</xref>
          ] provides the most advanced level of security;
• Automation – the use of intelligent codes to automatically apply business
rules allows a higher level of automation [
          <xref ref-type="bibr" rid="ref12 ref7">7, 12</xref>
          ];
• Efficiency – eliminating unnecessary intermediaries, eliminating manual
processes, and reducing fraud can reduce operating costs and increase
economic efficiency;
• Auditable – store verified transaction data (logistics) on the serial,
timestamp, facilitate auditing and regulatory reporting.
3
        </p>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>Role of Blockchain in Healthcare</title>
      <p>Blockchain technology has numerous possibilities for application in the logistics
of health services and services, which impacts public health. It contributes to
quality production, transport, storage, distribution, and health technologies
(pharmaceuticals, medical devices, consumables). Decentralization and
encryption of block-based information can have many uses in health care.
These include rationalizing insurance activities, managing health processes
(immunizations, prevention and prevention campaigns), logistics of medical
devices and medicinal products, and provision of detailed confidentiality settings
for personal medical data.</p>
      <p>
        Blockchain can contribute to the safe production, transport, storage,
distribution, and application of health technologies (pharmaceuticals, medical devices,
consumables) and improving patient privacy. The patient’s participation in his
treatment and communication with various health professionals is increasingly
encouraged [
        <xref ref-type="bibr" rid="ref13">13</xref>
        ]. A process that Blockchain would be helpful. The key lies in
implementing and applying the technology through partnerships with healthcare
professionals willing to be part of the software applications operating with a
blockchain.
      </p>
      <p>Blockchain technology is well suited for tracking merchandise and
managing logistics chains to supply production materials, consumables, drug
substances, and medical devices. The pharmaceutical industry is actively exploring its
potential, seeking ways to deliver quality, safe, and effective medicines on the
market. Many of these studies already have evidence that has generated interest
in healthcare. The key lies in implementing and applying the technology through
partnerships with healthcare professionals, medical institutions, and
manufacturers wishing to be part of the users of software applications operating with
Blockchain.</p>
      <p>The main logistics units with a direct impact on public health are listed
below:</p>
      <sec id="sec-3-1">
        <title>3.1 Logistics of medical examinations and laboratory tests</title>
        <p>The process of protecting public health begins with the proper organization of
medical and laboratory examinations and tests. This is related to the coordination
of work schedules, the availability of operating rooms and examination rooms,
laboratories. The observation and coordination of the whole process of diagnosis
and treatment in the outpatient and hospital care facilities is a prerequisite for a
quality process for public health protection. The presence of trusted and accessible
specialists in the diagnostic and treatment process at all levels is a guarantor of
professional attitude on the part of doctors to public health.</p>
      </sec>
      <sec id="sec-3-2">
        <title>3.2 Management and control of medical records</title>
        <p>The review, diagnosis, and treatment procedures generate a massive amount
of medical data that needs to be correctly recorded, stored, and used to protect
patients’ rights. The collected medical information (records of diagnostic
examinations, scanners, research, laboratory tests, and medical records) is
valuable for determining the population’s health profile. Information flow
logistics is a complex task due to real chances of error, misuse, or correction.
These risks are kept to a minimum through blockchain, ensuring secure storage
and protection of patients’ data.</p>
        <p>
          Another medical data source is the numerous records of various mobile
healthcare applications, gaining increasing popularity in recent decades. Modern
technology development makes it possible to record in several real-time
indicators such as blood pressure, pulse, changes in sleep, motor activity, and many
others. This data stream can be used to solve current medical issues. Blockchain
offers a variety of storage, processing, and application capabilities [
          <xref ref-type="bibr" rid="ref14">14</xref>
          ]. An
example of this is the Healthbank application, a Swiss healthcare startup, which
offers its users a platform for sharing personal data and health information that
uses technology to store and manage health information in a secure environment
[
          <xref ref-type="bibr" rid="ref15">15</xref>
          ]. Such personal data, reflecting blood sugar, blood pressure, heart rate, diet
regimens, sleep, motor activity, can be taken from healthcare applications and
medical examinations. In a blockchain, they can be stored and used to develop
programs for the prevention, prevention, and treatment of patients and ultimately
improve public health.
        </p>
      </sec>
      <sec id="sec-3-3">
        <title>3.3 Checking and tracking of drug substances and substances</title>
        <p>Verification and traceability of drug substances and substances in the
pharmaceutical industry are common when medicinal products are returned to
producers in case of irregularities. When the wholesalers order a larger quantity
is another situation. Then unsold unnecessary amounts may need to be returned
to the pharmaceutical manufacturers.</p>
        <p>
          Data shows that the portion of returned medicines is small compared to sales
(about 2-3% of sales), with the annual volume ranging from $ 7 to $ 10 billion.
Economic indicators show that in 2016, the US pharmaceutical producer’s sales
were $ 323 billion [
          <xref ref-type="bibr" rid="ref16">16</xref>
          ]. The estimated 2018 revenue for the top 10 global
pharmaceutical companies (representing half the sales of the top 50 companies) is
$ 355 billion [
          <xref ref-type="bibr" rid="ref17">17</xref>
          ]. Accordingly, instead of destroying the returned medicines,
pharmaceutical companies prefer to resell them. To do so, they are legally obliged
to check the authenticity of the returned medicinal products. Here is the
blockchain’s place to provide the necessary information by pre-collected unique codes
or serial numbers from each primary or secondary packaging.
        </p>
        <p>In the United States, the Drug Supply Chain Security Act (DSCSA) states
that all US manufacturers must enter serial numbers or packet-level codes by
November 2018. In the coming years, these serial numbers will be used to check the
authenticity of returned medicines. In Europe, the Falsified Medicines Directive
(FMD) requires all medication similarly marked by February 2019.</p>
        <p>While the EU has chosen a centralized approach (allowing manufacturers
to upload serial numbers into a single EU regulator database and distributors to
contact it to verify medicines’ authenticity), such a centralized database
regulator does not exist in the US. Without such a system, one option is for any
distributor to integrate data with any pharmaceutical manufacturer that is logistically
unacceptable. A much better and recommended approach is for pharmaceutical
manufacturers to record their packages’ serial numbers through a blockchain that
serves as a decentralized database. After that, wholesalers and retailers can check
the authenticity of packages delivered through technology.</p>
      </sec>
      <sec id="sec-3-4">
        <title>3.4 Prevent counterfeiting of medicines and medical devices</title>
        <p>The ability to trace the origin of materials and products through blockchain is
particularly suited to distributing goods. Pharmaceutical companies that produce,
deliver, and sell products experience severe difficulties in tracking their products,
creating conditions for introducing counterfeit medicines into the system.
Counterfeiting is not limited to the production of medications but also covers a
significant share of medical devices manufacture. According to the World Health
Organization (WHO), 8% of medical devices in circulation are forged copies
(18). Counterfeit medicines and medical devices pose a serious risk to consumers
while causing severe losses to legitimate producers [19]. The introduction of
serial numbers of the packages recorded in the blockchain can guarantee the
originality of the products and the traded goods’ traceability. By switching the
drug through the supply chains, transactions can be recorded on a blockchain,
thus providing an unchanging register of the goods’ origin. This will enable all
stakeholders to track medicinal products and products throughout the lifetime of
deliveries. This would make it more challenging to import counterfeit medicines
into the distribution chain.</p>
        <p>Several pharmaceutical companies are experimenting with blockchain and
IoT to identify counterfeit medicines and track the temperature of delivery and
storage of their products, with real-time visibility for all actors in the supply
chain. The Innovative Medicines Initiative (IMI) is a consortium of small
pharmaceutical companies, universities, clinical laboratories, hospitals, patients’
representatives. Within the EU aimed at investigating cases of use and action
to detect counterfeit medicines in supply chains, using patient data and clinical
trials.</p>
      </sec>
      <sec id="sec-3-5">
        <title>3.5 Coordination and provision of certain transport conditions</title>
        <p>Logistics companies must adhere to strict rules on the transport and storage
of medicinal products and medical devices. These may include maintaining a
specific temperature range, humidity, air quality within certain limits, degree of
illumination. Environmental conditions during transport may have a direct impact
on the quality and efficacy of the medication.</p>
        <p>Thermally labile products such as vaccines, insulin preparations, and
others must be correctly packaged and thermally stabilized throughout the logistics
chain. A slight deviation in these conditions may render them unfit for use.
Today, the entire supply chain can be monitored through intelligent IoT devices,
whereby environmental factors are recorded over the lifetime of delivery.
However, as all actors in the chain (manufacturers, logistics companies, pharmacies,
and hospitals) maintain their accountability and control of distribution
processes, problems within individual segments along the chain are difficult to track.</p>
        <p>Blockchain technology provides a better way of coordinating between
individual actors and managing processes at individual distribution levels. Due to
its transparency, security, and accessibility to information, technology provides
a mechanism allowing each logistical trader to ensure that strict delivery rules
(including conditions for subsequent handling and storage) are respected. The
technology ensures traceability of the supplier’s transport route and shows
everyone in the chain the localization of the goods carried at any given moment. This
reduces the chances of fraud, theft, and counterfeiting of distributed goods, which
is a severe problem in the pharmaceutical sector [19].</p>
        <p>Smart contracts can also be programmed, which are automatically executed
when the necessary conditions are not met by notifying the chain’s parties. For
example, suppose that if there is a temperature difference during transport, the
user can easily see when the temperature fluctuation occurred and how fatal it
was for the product. Smart contracts can be automatically called within a
blockchain, which will reduce the amounts due to logistics companies based on
noncompliance with the storage conditions.</p>
      </sec>
      <sec id="sec-3-6">
        <title>3.6 Providing informed consent in clinical trials</title>
        <p>The patient’s informed consent includes notification of each step in the clinical
trial, including any possible risks associated with the study. The reconciliation
protocols and their revisions should be transparent to patients and traceable to
stakeholders. In practice, however, the informed consent process is challenging
to implement rigorously and satisfactorily. There are some issues related to
collecting information, including difficulties in obtaining informed consent,
incorrect forms, invalid consent documents, non-admission of revised protocols.
Documentary frauds are also frequently reported (e.g., generating documents for
retroactive agreement).</p>
        <p>Establishing protocols from blockchain clinical trials, transparency, and
traceability of patient awareness and consent are ensured. It provides a
mechanism for compiling, storing, and tracking information in a secure and publicly
transparent way that allows this information to be shared in real-time. Besides,
smart contracts may be linked to revisions so that any change in the clinical trial
protocol requires the patient’s consent to be renewed.</p>
      </sec>
      <sec id="sec-3-7">
        <title>3.7 Logistics network in hospitals</title>
        <p>Medical establishments are one of the essential structures working to protect
public health. Tracking hospital deficiencies and resource planning is a crucial
element in hospital logistics. For this reason, more than 30% of total hospital
costs are invested in logistics activities, and half of these costs can be eliminated
through proper logistics management [20]. Improvements in the supply chain
in hospitals can provide secure operating theaters and the necessary medication
and supplies, better resource management, correct supplier relationships, more
pleased patients, and more efficient workflow for hospital staff.</p>
        <p>Logistics activities in hospitals include purchasing, inventory, and
managing medical goods, information systems, nutrition, transport, home care. In the
list, the hospital and medical departments interact with the distribution chains.
This requires more human resources and space for manipulation, which in turn
increases implementation costs.</p>
        <p>Schedule planning focuses on adherence to terms and quantities of orders.
Thus, the acquisition of essential goods and services is limited by the available
resources, avoiding overloading. Process coordination through blockchain can
significantly reduce costs by increasing hospital services’ effectiveness and
benefits to public health.</p>
      </sec>
      <sec id="sec-3-8">
        <title>3.8 Human resources management in Healthcare</title>
        <p>Blockchain could be useful in the process of managing human resources at
various levels in the healthcare field. Starting at the level of education in schools
and universities, we go through healthcare facilities and industries and get to the
national level.</p>
        <p>This would ensure a transparent selection process. Managing information
through technology would allow at any moment to trace the level of competence
and expertise of experts in the field (22). It will also make visible staff with a staff
shortage and stimulate the education system to produce priority specialists from
whom the healthcare sector is most in need.</p>
      </sec>
      <sec id="sec-3-9">
        <title>3.9 Logistics of medical devices</title>
        <p>Blockchain technology can be very useful in securing the complete logistics chain
for medical devices, including “origin” and “tracking” of products in real time.</p>
        <p>The record of production data through blockchain proves authenticity,
quality, and a guarantee of patent ownership. The technology helps the
complex logistics chains associated with the effective tracking of a product’s origin,
starting with the materials, going through the production process and
distribution, and reaching the end-user.</p>
        <p>MD production and distribution chain includes various actors –
manufacturers, distributors, wholesalers, pharmacies, hospitals. Each participant is
interested in knowing the source of the materials/products and can track his/
her real-time traffic at any time. This is not easy to achieve with traditional
technologies and business models. Despite the ongoing efforts to document
the distribution chain, the lack of continuity, the disruption of the
individual stages, and the problematic tracking of information, potential frauds, and
the counterfeiting of medical devices are possible. Using a blockchain, each
transaction in the supply chain can be accurately tracked, from the origin to
the ultimate distributor, ensuring the delivery of the desired product. Many
stakeholders recognize the role technology can play in solving these problems.
Blockchain is an ideal solution to tracking pharmaceuticals and medical
devices, as it provides greater confidence through consensus, transparency, and
security of the logistics chain.</p>
        <p>Over the last two decades, global regulation has introduced unique product
identification requirements to provide greater security for delivery. These
requirements aim at eliminating falsified and diverted products, which contributes
to enhancing the safety of end-users. With the introduction of blockchain,
logistics chain partners can exchange data more effectively and securely for specific
deliveries. Ultimately, each participant has up-to-date and accurate information
about the logistics process. Through a blockchain, established irregularities
along the chain will directly alert all affected persons (manufacturers,
distributors, distributors, and even patients). They can track and verify the downloaded
product by minimizing the time required to dispose of articles while reducing
the cost of withdrawing and blocking effects from the market, scrapping losses,
and the risks of using poor quality medical devices and medications.
4</p>
      </sec>
    </sec>
    <sec id="sec-4">
      <title>Conclusion</title>
      <p>These examples describe the numerous capabilities of blockchain technology.
The healthcare sector is among the priority users of innovation and serves
public health management, the storage of medical data from various sources,
including the patient, as well as an active role in counterfeiting of medicines.
The considerable potential of this technology is wherever a third party is needed
in settlement of a number of market services. With blockchain, direct deals are
possible without the availability of intermediaries, which saves time, resources,
and reduces risks. Benefits that make technology indispensable in the world of
modern logistics.
2010, Available:
https://www.news-medical.net/news/20100128/Over-825-of-medical-devices-in-circulation-are-counterfeit-WHO. aspx [Accessed 19 March 2021].
19. Bansal D., Malla S., Gudala K. and Tiwari P., 2012. Anti-counterfeit technologies: a
pharmaceutical industry perspective. Scientia pharmaceutica, 81(1), pp.1-14.
20. Poulin E. Benchmarking the hospital logistics process: A potential cure for the ailing health care
sector. C Mag. 2003; 77(1):20.
21. Vander T.A., How Blockchain Will Transform Credentialing (and Education), Available:
https://www.gettingsmart.com/2017/12/blockchain-will-transform-credentialing-education/
[Accessed 11 March 2021].
22. Leventi N., Yanakieva A., Stoimenova A., “Introduction of EBM in Medical Professionals’
Education in Bulgaria, in Association with the HTA Process – A Pilot Study”, ISPOR Europe
2018, 10-14 November 2018, Barcelona, Spain.</p>
    </sec>
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