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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Distributed Medical Rule Engine (DMRE)-Pro ject</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Doctoral Consortium</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Tiani "Spirit" GmbH</institution>
          ,
          <country country="AT">Austria</country>
        </aff>
      </contrib-group>
      <abstract>
        <p>In medical-clinical informatics supporting medical research and medical routine is a core business. Through growing medical knowledge, medical doctors need to track all this new knowledge and activities. To support this high ow on specialized new information an IT-solution could be helpful. This solution takes care of the patient's data, as well as on existing and emerging medical knowledge and various medical processes. The main issue is combining these three entities to answer medical questions for a speci c patient for a certain use-case. The intention is to nd a generic methodology for the combination by using semantic technologies, FHIR as medical-data-standard and ontology-mappings.</p>
      </abstract>
      <kwd-group>
        <kwd>FHIR mantic technologies</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>Introduction</title>
      <p>as well from a technical point of view. Currently, there is no standardized, formal
way to achieve interactions in between processes, medical knowledge and data,
to achieve the purpose of decision support.
2
2.1</p>
    </sec>
    <sec id="sec-2">
      <title>Background</title>
      <sec id="sec-2-1">
        <title>Data-De nition</title>
        <p>
          Fast Healthcare Interoperability Resources (FHIR): Fast Healthcare
Interoperability Resources (FHIR) is a standard framework de ned by Health Level 7
(HL7). The core of FHIR contains so called \resources" and \APIs" as primary
components [
          <xref ref-type="bibr" rid="ref5">5</xref>
          ]. Resources are information models de ning data elements
including constraints and relationships in between. This means FHIR describes
the data-structure, the data- ow and the connection between di erent
FHIRresources. The aim of the FHIR Standard is [
          <xref ref-type="bibr" rid="ref7">7</xref>
          ] to enable the exchange of
healthcare-related information, by reusing existing standards as HL7-Version
2 and Clinical Document Architecture (CDA). There is a focus on
implementing fast and easy solutions, but also taking web standards like XML, JSON,
HTTP, OAuth, etc. into account [
          <xref ref-type="bibr" rid="ref9">9</xref>
          ]. One more goal of this standard is to ensure
the interoperability. There exists also the option to represent FHIR-resources
as RDF-graphs [
          <xref ref-type="bibr" rid="ref8">8</xref>
          ]. This option is mainly used to bridge information between
the data which is generated during operations and formal knowledge processing
systems.
2.2
        </p>
      </sec>
      <sec id="sec-2-2">
        <title>Problem in the eld</title>
        <p>
          Medical work ows are getting more relevant through medical studies and
standardizing medical processes [
          <xref ref-type="bibr" rid="ref1">1</xref>
          ]. There is a variety of medical guidelines, which are
interesting for the di erent medical disciplines and medical application areas. For
example, there is a guideline for chronic cardiac insu ciency [
          <xref ref-type="bibr" rid="ref3">3</xref>
          ] which is a
common disease for persons older than 60 years. The presented medical data exists
in a standardized form (FHIR), but without any relation to one another. As an
example: Elderly patients are taking medication to lower their pulse-rates. In the
technical representation of the FHIR-resources, this link between the pulse-rate
and the in uence of the medication is missing. Medical knowledge is available in
the form of di erent ontologies. Currently, the combination of medical guidelines,
medical data, and the associated ontology is not available. Even the semantics
of the di erent medical resources stored as FHIR-observations to each other is
missing. Representing the di erent relationships is of high importance for
making decisions. Furthermore, the issue of highly distributed medical-data-stores is
given. This means medical data from one single patient can be stored either in
the same physical location, but also in multiple di erent locations. A problem is
the generation of a complete view of the patient's data and all relations between
the data. One more issue regarding FHIR is, that the FHIR-data-model is not
intended for semantic queries since it is built upon records, rather than stating
facts (e.g. "The Patient A has a heart attack")[
          <xref ref-type="bibr" rid="ref8">8</xref>
          ].
        </p>
        <p>In a more generic way, the problem- eld is within the combination of
processknowledge, ontologies, and a certain sort of data. The issues which arise during
the combination are about the integration of data and ontologies to nd the
semantics of the single data, but also to nd all available data for a given
representation in the ontology. The medical guideline needs to be applied to a concrete
data-set for a patient, but also the ontology for a step in the guideline is
relevant. For example, nding the blood-pressure for the patient. The rule-engine
rst needs to retrieve the \coding" for blood-pressure in the Ontology. One more
problem is the question, which guideline to apply for a given set of data (e.g.
which guideline take care of high blood pressure?) Also the question { \has the
patient a medical issue" should be answered, related to the given ontology, the
known medical guidelines, and the patient's data in order to react properly on
common but also on rare diseases.
3</p>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>Related Work</title>
      <p>This section describes work, done by others which are related to the eld of the
theses, and to nd open tasks.</p>
      <p>
        The work 'Structurally Mapping healthcare data to HL7-FHIR through
ontology alignment' [
        <xref ref-type="bibr" rid="ref11">11</xref>
        ] analyses the possibility of a transformation of any
healthcare data. Since the argumentation is about di erent healthcare-formats the
incoming data needs to be analyzed in order to transform via an
ontologyalignment to FHIR-resources in terms of structure. There are referenced a
knowledge base to take care of the ontologies and relationships, and a structure
mapping library. The structure translator provides a mechanism for setting the
correct FHIR-format and put the values in the given FHIR-version-3 form. There
is also a way to get a complete overview of the resources and the relationship
among each. This solution also stores the combined information in a triple-store,
but has a ip side when thinking on interoperability (since FHIR is meant to
exchange observations between di erent healthcare-actors), and creating views
"on the y", with already existing data. Even a change of patient-information
might cause issues in terms of the need to change the complete patient's
information in every stored entity. There is also a need to nd the ontology within
an FHIR-resource, but this is not done yet.
      </p>
      <p>
        In [
        <xref ref-type="bibr" rid="ref14">14</xref>
        ] the approach for modelling validating FHIR-Pro les is using semantic
web shape expressions (ShEx). For this purpose, the FHIR-resources, which are
represented either in JSON-format or XML-format are transformed. The
transformation which needs to be done is from FHIR-JSON to RDF. This is done
using an implementation by the HL7-Community. Somehow this function is not
present anymore, there is an implementation missing. In [
        <xref ref-type="bibr" rid="ref14">14</xref>
        ] the conversion of a
single resource mentioned, but not the combination of multiple resources. Such
a conversation will be needed in a productive environment, where a combination
of di erent resources is done to generate an RDF-graph over the resources. In
some tests done with an old version, it occurred that the transformer is not able
to convert resource-bundles, but just single FHIR-resources.
      </p>
      <p>
        The idea in [
        <xref ref-type="bibr" rid="ref4">4</xref>
        ] is to take healthcare data (in di erent formats like
HL7-V2Message, or FHIR-resources) as input, encode it to RDF and store it into a
triplestore database. The described query-stage then returns the matching
results. Therefore SPARQL is being used. This engine acts simultaneously as a
collector and a bus for delivering messages to sources, as well as a real-time
analytic platform. This means the 'semantic enrichment machine' takes the
FHIRresources, transforms it to RDF, and stores them. This has the issue that existing
FHIR-Data can not be used for further transactions because it is not available
in the triple-store.
      </p>
      <p>
        A medical guideline can technically be represented in Guideline Interchange
Format version 3 (GLIF3) [
        <xref ref-type="bibr" rid="ref13">13</xref>
        ]. There are dependencies on the
HL7-ArdenSyntax [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ] and Medical Logic Modules (MLM). GLIF3 models a clinical guideline
as a owchart. The goal of GLIF3 was to nd a representation format for sharable
computer-interpretable clinical practice guidelines. The Arden syntax itself is a
knowledge representation standard for medical knowledge and allows queries to
existing data. The de nitions on the MLMs are strict, the formulation on the
'rules' need to be exact. This means it takes an action on each input (e.g. if
heart-rate is higher than 100 bpm (beats per minute), alert the doctor), and it
does not build up an information-chain for taking decisions. In this case a 'longer'
time period for evaluation would be helpful, to avoid not needed alerts. Even
every single 'medical knowledge' needs to be built up by a person, and there is
not a possibility to rely on existing information. Because of the high integration
of Arden-Syntax to GLIF3, and a needed possibility to build semantic graphs
over medical information and medical knowledge, GLIF3 is not a usable option.
      </p>
      <p>
        To summarize these works: there are di erent transformers (from proprietary
format to FHIR, from FHIR to RDF), and also the approach for storing in RDF
or creating some FHIR-like-resources. These transformations are needed, to nd
a common 'language' for traversing an RDF-graph, for nding the needed
information. It is also needed to have 'standard-FHIR-resources' (which are not
enriched for a special use case) and to use them for better patient treatments.
All found approaches are nonworking mechanisms for resolving ontologies within
FHIR-resources. FHIR itself provides an ontology [
        <xref ref-type="bibr" rid="ref6">6</xref>
        ]. It de nes the formal
structure of the individual FHIR-resources, but not in the medical context.
4
      </p>
    </sec>
    <sec id="sec-4">
      <title>Research questions and hypothesis</title>
      <p>The over-all question is how to nd the semantics of medical data, and how
semantic technologies can be applied to medical data and medical guidelines and
medical knowledge. Including the question of how to apply medical guidelines
on withing the semantic context to answer medical questions during a medical
assessment.</p>
      <p>I assume that there is a generic methodology for automated processes in
ruleengines to be combined with medical data. This allows answers to the questions
which arise during the execution of a medical guideline.</p>
      <p>More speci c questions are about the di erent components:
1. Is there a system-architecture which can build up a solution to satisfy the
needs of the over-all solution?
The hypothesis is that there can be created an architecture which allows to
operate a system to cover the needs for a rule-based medical decision support
system.
2. How to transform medical guidelines (technically) in a way that a rule-engine
can apply these guidelines and execute the di erent work ows?
The expectation is that a rule-engine is the right tool to perform a medical
guideline in general. It is also expected that it coordinates and orchestrates
di erent tasks. Moreover, it can take decisions based on the input.
3. How to extend rule-engines in a way to deal with 1.) medical data and 2.)
medical knowledge?
The extension of a rule-engine is possible for the special case of medical
applications, to handle this speci c data also in a semantic context.
4. How are the relations between medical data/guidelines and medical
knowledge described?
The belief is that there is a semantic relationship among all these
components (medical data, medical knowledge and medical guidelines), which need
to be \merged" together, to reach the goal of semantic interoperability.
5. How to do semantic queries towards a medical-data-store (in this special case
an FHIR-store)?
Since there is an RDF speci cation for FHIR-resources, the premise is there
is a technical option for the FHIR-JSON-to-RDF conversion.
5</p>
    </sec>
    <sec id="sec-5">
      <title>Research Design and methods</title>
      <p>
        As research methodology, Design Science is chosen, because it provides speci c
guidelines for the creation and evaluation of IT artifacts. The following guidelines
should be implemented in the course of the work:[
        <xref ref-type="bibr" rid="ref10">10</xref>
        ]:
{ Design as an Artifact
{ Problem Relevance
{ Design Evaluation
{ Research Contributions
{ Research Rigor
{ Design as a search Process
{ Communication of Research
These guidelines will be used throughout the development of the thesis. An
artifact will be developed, and the problem relevance will be described in the
problem statement. The evaluation will be done in each single design artifact as
well as in the overall solution. The overall evaluation will be done on a medical
use case for a patient having a heart attack, expecting the solution to nd that
the patient has a heart attack, and providing the appropriate medical guideline
to the doctor.
      </p>
    </sec>
    <sec id="sec-6">
      <title>Proposed solution</title>
      <p>The solution is partitioned in di erent parts which all will t together in an
over-all-solution for the problem.</p>
      <p>The architectural part: from an architectural point of view it is a a
centralized as well as a decentralized approach. The services can be applied on
di erent servers, to do the needed calculations and transformations. Then it is
possible to hold all information at the point of origin but just the needed
information is then submitted to a central service, so that there is no need for huge
data-transfers. Nevertheless the important (reduced) results are then centrally
available and ready for processing. If there is a need for processing the data in
the central environment the services there can also be used. There are di
erent services needed, which can be executed during run-time. The dependencies
on the services are loosely coupled, just the rule-engine itself, as the central
work ow-component is a 'must' for the other services. For example, if there is
no need for a FHIR-Query-Service, there is no need to activate it during the
execution of the rule-engine's work ow. The rule-engine itself takes care of the
over-all communication and coordination as well as the results from the di erent
services. Decentralized services are specialized ones to act as an interface towards
the di erent FHIR-Stores, and on the other hand, are they an interface for the
central component. Since knowledge can be widely distributed a decentralized
approach is needed to resolve all the available information for a use-case. The
rule-engine as the core-service to evaluate the results and take decisions should
be a centralized one.</p>
      <p>The technological part:</p>
      <p>Distributed medical service engine (DMSE)
«Service»
Rule-Engine
«Service»
SPARQL
«Service»
Medical-Guideline
«Service»
FHIR-Query</p>
      <p>«Service»
Terminiology-Query
«Service»
FHIR-Store
«Service»
FHIR-to-RDF-Converter</p>
      <p>Onto«loSegrvyic-eQ»uery
As shown in the image above there are di erent services available on the
solution to provide a certain function. The services are:
1. Rule-engine
2. FHIR-Query
3. SPARQL
4. Terminology-Query-Service
5. Medical-guideline-service
6. Ontology-query-service
7. FHIR-Store-Service
8. FHIR-to-RDF-Converter.</p>
      <p>
        The services are able to interact with each other, provide information on
requests, decide during the work ow, process incoming data or read medical
guidelines.
1. The Rule-Engine: the rule-engine is the central component in the system
architecture. It covers the main work ow during di erent medical processes
like inserting new Observations, but also the medical guideline. The
ruleengine also takes care of the execution of the di erent medical guidelines.
To ful ll this task the rule-engine has to strongly interact with the other
services.
2. FHIR-Query-Service: the FHIR-Query service allows the solution to perform
queries towards an FHIR-Store to provide the patient's relevant information
to the rule-engine. The query can either be done by the standard
Hl7-FHIRServices or by an intermediate layer (the FHIR-to-RDF-Converter), to get
results in RDF-TTL-Format.
3. FHIR-Store-Service: The FHIR-Store service, takes care of all information
that should be stored into an FHIR-Store. This service decides which is the
correct FHIR-Store, and due to the interception, this service can also enrich
data with other relevant information (e.g. intake of medications and the
e ect on the pulse-rate).
4. SPARQL-Service: this service allows the rule-engine to ask SPARQL-queries
towards the result of the FHIR-Query-Service or the FHIR-to-RDF-
Converter. These services hold its data in RDF-Format, and so SPARQL-Queries
can be asked.
5. Terminology-Query-Service: The Terminology-Query-Service is relevant for
semantic interoperability. By using this service, it is possible to use consistent
terminologies in the distributed environment. This applies for the
storagecomponent as well as to the query-component [
        <xref ref-type="bibr" rid="ref15">15</xref>
        ].
6. Medical-guideline-service: this is a very central service since it needs to cover
the execution of the guideline. This service holds information on the rules.
7. Medical-knowledge-query-service: This service returns results on medical
questions. For example: what is the meaning of a certain value in a dataset?
What does the result mean in the over-all-context?
8. FHIR-to-RDF-Converter: This service cares on the correct transformation
from FHIR-JSON-Objects to RDF-TTL, to allow SPARQL-Queries on the
result-set. This service converts FHIR-resource-bundles and single resources
as well.
      </p>
      <p>Work ows in the system architecture: in the distributed system the
workow is important. The work ow is de ned by two things: 1.) a general
path/decisionpart for the execution-environment and 2.) by the rule-engine which takes
content from the medical-guideline. Besides the rule-engine for the work ow
described earlier, the general path describes the work ow through the services in
di erent network-endpoints.</p>
    </sec>
    <sec id="sec-7">
      <title>Conclusion</title>
      <p>Concluding there is the idea of a system-architecture, which needs to be proved
and implemented, as well as the technological part, to cover the needs for a
support system, and to resolve the relevant information for the medical doctor as
well as for the patient. The architecture describes a centralized and decentralized
approach at the same time, by having certain services located in the edges of the
needed (medical) network, but the core-components on a central place to make
decisions and guide trough the designated work ow for a medical use-case.</p>
    </sec>
  </body>
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