<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Archiving and Interchange DTD v1.0 20120330//EN" "JATS-archivearticle1.dtd">
<article xmlns:xlink="http://www.w3.org/1999/xlink">
  <front>
    <journal-meta>
      <journal-title-group>
        <journal-title>G. Piho, J. Tepandi, D. Thompson, T. Tammer, M. Parman, V. Puusep, Archetypes based
meta-modeling towards evolutionary, dependable and interoperable healthcare information
systems, Procedia Computer Science</journal-title>
      </journal-title-group>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="doi">10.1147/sj.382.0454</article-id>
      <title-group>
        <article-title>Evaluating business meta-models for semantic interoperability with FHIR resources</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Rainer Randmaa</string-name>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Igor Bossenko</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Toomas Klementi</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Gunnar Piho</string-name>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Peeter Ross</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Department of Health Technologies, TalTech</institution>
          ,
          <addr-line>Akadeemia 15A, 12618 Tallinn</addr-line>
          ,
          <country country="EE">Estonia</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Department of Software Science</institution>
          ,
          <addr-line>TalTech, Akadeemia 15A, 12618 Tallinn</addr-line>
          ,
          <country country="EE">Estonia</country>
        </aff>
      </contrib-group>
      <pub-date>
        <year>2022</year>
      </pub-date>
      <volume>37</volume>
      <issue>2014</issue>
      <fpage>457</fpage>
      <lpage>464</lpage>
      <abstract>
        <p>Information systems interoperability in health care has proved a dificult challenge due to the semantic heterogeneity of models, data, messages, etc. So far, attempts to solve this problem have involved a unified approach through the development and utilisation of common standards. However, this approach has issues in semantic heterogeneity; if the standardised data models and exchange protocols are developed by diferent vendors, they tend not to be interoperable. A federated interoperability approach where models can be dynamically specified at run-time rather than being predetermined might be a useful supplement to the unified interoperability approach. In this workshop paper, we propose executable business meta-models, which, according to our understanding, can be utilised as a shared ontology to achieve federated interoperability. We evaluate these meta-models by illustrating semantic interoperability with FHIR resources, the building blocks of the healthcare interoperability standard developed by HL7. For the evaluation, a distributed test environment is set up to illustrate how data are exchanged and transformed back and forth. Here, NextGen Connect (Mirth Connect) is used as a mapping engine between FHIR and the meta-models. We believe our work is an important contribution to the seamless no-code/low-code federated interoperability of health information systems, whereby diferent systems can exchange medical data in a semantically coherent way using diferent protocols and data models and their versions, such as FHIR, HL7 v2.x, openEHR.</p>
      </abstract>
      <kwd-group>
        <kwd>- FHIR</kwd>
        <kwd>Mirth Connect</kwd>
        <kwd>Interoperability</kwd>
        <kwd>EHR</kwd>
        <kwd>Meta-model</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1. Introduction</title>
      <p>
        The complexity of data and information systems in the field of healthcare informatics creates
many challenges in using health data for advancing medicine, science, population health and the
economy. Data exchange between healthcare systems is specifically challenging because of the
semantic heterogeneity of data models. Diferent vendors in health care use diferent standards
and specifications as predetermined models when developing their applications, making data
incompatible between systems. A federated interoperability approach where models can be
dynamically specified at run-time rather than being predetermined might be a useful supplement
to the unified interoperability approach, meaning that there is a common meta-level structure
across constituent models [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. We believe that meta-models based on business archetypes can
be utilised as a shared ontology to achieve federated interoperability. A system using these
meta-models allows specification of models during run-time and transformations between them.
A means to exchange health data without afecting their quality is critical to the secondary use
of health data.
      </p>
      <p>These meta-models need to be evaluated and tested with existing healthcare information
models. HL7 FHIR is one of the newer standardised communication protocols in health care
and is constantly gaining popularity. This paper aims to illustrate and explain the process of
validating these meta-models as well as integrating the systems developed using FHIR models
by implementing proof-of-concept data exchange channels between FHIR and the meta-models.</p>
    </sec>
    <sec id="sec-2">
      <title>2. Methodology</title>
      <p>
        For developing the proof-of-concept integration between HL7 FHIR and business
archetypebased meta-models, the integration architecture is designed using enterprise integration patterns
and principles [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. Semantic mapping between FHIR models and the meta-models is performed
and displayed using UML diagrams. NextGen Connect (Mirth Connect) is used as an integration
engine to implement the architecture and mapping by aggregating Mirth Connect channels
to achieve the desired result. Channels in Mirth connect are developed using a mixture of
JavaScript, Java and SQL. The mapping implementation also makes use of the HAPI FHIR API
[3], an open source HL7 FHIR API written in Java. With the help of HAPI, FHIR messages can be
serialised into Java objects, which makes the mapping code more reliable and easier to write [4].
To test the integration, an instance of the meta-models based software, ABC4HEDA, is deployed
on a virtual machine with a Microsoft SQL Server as the persistence layer. Mirth Connect is
deployed on a separate virtual machine. This is done using Microsoft Azure cloud services and
mimics a distributed environment. A set of example resources is provided by HL7 on the oficial
FHIR documentation website [5], which are used as messages when testing the integration
implementation. Messages are sent using Postman [6]. Critical retrospective analysis is then
performed on the process of developing this proof-of-concept.
      </p>
    </sec>
    <sec id="sec-3">
      <title>3. Archetype pattern-based meta-model</title>
      <p>The proposed business meta-models for semantic interoperability are based on business
archetype patterns [7] in combination with the Zachman Framework [8] applied to health
data. The meta-models discussed in this chapter build on previous work regarding archetypes
based meta-modeling for healthcare [9].</p>
      <p>One of the archetype patterns we need to utilise in the context of this paper is the Party
archetype pattern. The central part of this pattern is the Party archetype 1. The Party archetype
pattern is used to describe the parties involved in business activities, such as a person or an
organisation. Parties have many attributes, such as names, contacts, identifiers, capabilities and
preferences. The Party archetype pattern is complemented by the PartyRelationship archetype
pattern, which allows us to describe how these parties relate to one another, e.g. a client-supplier
relationship.</p>
      <p>Another archetype pattern we will encounter in this paper is the Product archetype pattern,
at the centre of which is the Product archetype, illustrated in Figure 2. This figure also illustrates
the use of the Item Description pattern[10], which is used throughout the meta-models. The</p>
      <p>Product archetype pattern is used to describe any product or service a business provides or
uses to provide another product or service. In other words, a product can be thought of as any
item or service used in business processes. The ProductType archetype represents a product’s
generic information, and the Product is a specific physical instance of the type. When you go
into a shop to buy a product, the ProductType represents the information the salesperson gives
you verbally or in a catalogue or leaflet, and the Product represents the actual thing you walk
out the door with. In the context of health care, a product might be a blood sample in storage,
medicine ready to be administered or a consultation booked.</p>
      <p>In addition to the aforementioned archetype patterns, the meta-models also implement
Order, Inventory, Rule, Money and Quantity archetype patterns with the inclusion of the Process
archetype pattern developed by Gunnar Piho by abstracting the Customer Relationship
Management archetype pattern[11]. We believe that these archetype patterns can be used as a Single
Underlying Model (SUM) [12] for healthcare data models. The important aspect to highlight
about these meta-models is that data and knowledge of the data are decoupled.</p>
      <p>The software implementing these models is ABC4HEDA. It is written using the latest .NET
framework. In addition to executable domain models, data models using pure POCOs (Plain Old
CLR Objects) and an infrastructure layer, ABC4HEDA contains an administrator UI component
developed with ASP.NET. Of the 120K lines of source code, ca 45% are automated unit tests and
UI acceptance tests, resulting in the high reliability and test coverage of the code base.</p>
    </sec>
    <sec id="sec-4">
      <title>4. HL7 FHIR</title>
      <p>Fast Healthcare Interoperability Resources (FHIR) is a healthcare interoperability standard in the
HL7 family that defines simple structures for a RESTful data exchange protocol. The FHIR model
consists of modular resources based on simple XML or JSON structures that can be extended
beyond the base model in a standardised manner [13, 14]. As FHIR seems to be growing in
popularity, the standard’s semantic interoperability with the proposed meta-model needs to be
validated and an integration solution with systems based on FHIR needs to be researched and
developed.</p>
      <p>FHIR is an evolving standard. New versions of FHIR are published on a release cycle of
approximately 18-24 months. Each new release is assigned a unique version number. The
proof-of-concept built in this paper uses two resources from the FHIR Release 4 (R4) model:
the Organisation and the Specimen resource. The Organisation resource is used to describe a
formally or informally recognised grouping of people or organisations formed for the purpose
of achieving collective action [5]. The Specimen resource is a clinical concept. It is used to
describe any material sample to be used for analysis. The Specimen resource covers substances
used for diagnostic and environmental testing. The focus of the Specimen resource is the process
for gathering, maintaining and processing the specimen as well as the origin of the specimen
[5].</p>
    </sec>
    <sec id="sec-5">
      <title>5. Integration using Mirth Connect</title>
      <p>NextGen Connect (Mirth Connect) is an open source healthcare integration engine, for which
enterprise extensions that require a subscription are available. The integration unit between
a sending app and a receiving app in Mirth Connect is called a channel. In other words,
oneto-many abstract unidirectional pipes to decouple components from one another to transfer
healthcare data between two or more applications. The channel architecture implemented in
Mirth Connect can divide a large message processing task into a sequence of smaller independent
steps [15]. A channel consists of a Source connector, a Destination connector and a Response
connector. Each has their own set of configurable filters and transformers. Channels can also be
used in conjunction for integration problems with complex requirements.</p>
      <p>Mirth Connect ofers a few ways to implement mappings between two message formats. The
low-code version uses message templates. This is the preferred option for a non-developer
individual, but to our understanding, there is no straight-forward way to obtain consistent
templates for FHIR messages. The reason for this is the extendibility and flexibility of the FHIR
format. Because of this, the majority of the channels must be implemented using custom scripts
written by a programmer. It is interesting to note that Mirth Connect does have an oficial
FHIR extension, but to our knowledge it does not fully address the problem of accessibility.
A graphical FHIR resource builder is provided, but it can only be used to construct resources
and not the other way around. Frankly, it is also quite clunky to use when iterating through
collections. The oficial extension provides a FHIR endpoint and FHIR resource validation,
though, which can be very useful.</p>
      <p>As the initial proof-of-concept, the integration will be as simple as possible. Our system will
have two endpoints, one for inserting data in FHIR format and one for requesting data in FHIR
format, as shown in Figure 3. A notable constraint with developing this integration is that the
ABC4HEDA software currently has no web API, so the database will need to be queried directly.
In the context of a prototype, this is not much diferent than communicating with a RESTful
API where each database table is often allocated its own resource endpoint.</p>
      <sec id="sec-5-1">
        <title>5.1. From FHIR to meta-models</title>
        <p>
          For inserting data in FHIR format to the ABC4HEDA database, an endpoint should be able to
listen for an incoming FHIR message and then split it into instances of resources using the
Splitter pattern [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. Each resource gets routed to its corresponding transformer channel using
the Content-based Router pattern[
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. Each transformer channel is responsible for mapping the
incoming data to business archetypes and inserting them into the database. The integration
architecture for inserting data is illustrated in Figure 4a.
        </p>
        <p>
          A resource transformer channel will deserialize the FHIR message into a HAPI FHIR [3] Java
class instance and then break the resource down into business archetypes, once again using the
Splitter pattern [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. Each step of the transformer channel generates an SQL INSERT statement
for each instance of the corresponding business archetype. These SQL statements are then
executed as a transaction. This is illustrated in Figure 4b
        </p>
        <p>(a) FHIR to Mirth to ABC4HEDA.</p>
      </sec>
      <sec id="sec-5-2">
        <title>5.2. From meta-models to FHIR</title>
        <p>
          For requesting a resource from ABC4HEDA in FHIR, we need to have another FHIR endpoint
listening for a GET request with the resource type and ID specified. This ID is then routed to the
correct FHIR resource builder channel using the Message Router pattern [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. The resource builder
channel then queries the database, builds the FHIR resource and sends it back as a response
to the request. This architecture is illustrated in Figure 5a. A resource builder channel creates
(b) FHIR resource to business archetype
transformer channel.
        </p>
        <p>
          (a) ABC4HEDA to Mirth to FHIR.
(b) Business archetype to FHIR resource builder
channel.
an empty HAPI FHIR [3] Java instance of the resource. Based on the received ID, each builder
step makes a series of SELECT queries to populate the FHIR resource segments, resembling the
Aggregator pattern [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. The Java object is then serialized into JSON and sent as a response. This
is illustrated in Figure 5b.
        </p>
      </sec>
    </sec>
    <sec id="sec-6">
      <title>6. Mapping FHIR resources and business archetypes</title>
      <p>Semantic mapping between the FHIR R4 model and business archetypes is a way to assess
and validate the compatibility of meta-models with the FHIR specification. This process gives
insight into not only how the FHIR model should be specified in the meta-models, but also
the potential shortcomings of business archetypes in the context of healthcare. Mapping a
segment of a FHIR resource to the meta-models can be achieved by abstracting the concept
it represents and matching it to a business archetype or a segment of an archetype, relying
on definitions from the FHIR documentation [ 5] and Arlow and Neustadt’s work [7]. On the
mapping diagrams in the following subsections, FHIR resource segments are inside the orange
background and business archetypes are outside.</p>
      <sec id="sec-6-1">
        <title>6.1. Organisation</title>
        <p>An FHIR Organisation resource is an instance of the Organisation business archetype, which
is a subclass of the Party archetype. The Organisation resource has a type, which maps to
the OrganisationType archetype, as illustrated in Figure 6. The Organisation resource has a
boolean field to represent whether it is active or not. Being an active organisation is semantically
equivalent to having a capability that is a prerequisite for doing anything, so this is an instance
of the PartyCapability archetype. The Organisation resource has a name and aliases, both of
which map to the OrganisationName archetype with the name types of primary and other,
respectively. The Organisation resource has identifier ifelds, which are business identifiers,
meaning that they extend beyond the context of a single system. These fields are also of a
complex FHIR Identifier data type. In business archetypes, these identifiers are represented
by the RegisteredIdentifier archetype. In fact, the entire FHIR data type seamlessly maps to
this archetype, as illustrated in Figure 7. The Organisation resource’s telecoms, addresses and
endpoints are all instances of the PartyContact archetype, which represents the information
that can be used to contact a party. The resource’s address fields represent geographical contact
information, telecoms are either phone numbers (or similar), e-mail addresses or web addresses
and endpoints are a special type of web address 6. The Address and ContactPoint FHIR data
types both map to the PartyContact arhcetype, as seen in Figures 8 and 9. The Organisation
resource has a partOf reference field to use when the organisation is a part of a larger whole.
In business archetypes, this is modelled with the PartyRelationship archetype pattern, where
the parent organisation is in the consumer role and the child organisation in the provider role.</p>
        <p>Finally, the FHIR Organisation resource has a Contact component, which is a human who
is a contact for the organisation for a certain purpose. In terms of business archetypes, this
is an instance of the Person archetype, another subclass of the Party archetype. The
connection between the organisation and the contact person is modelled with the PartyRelationship
archetype pattern, where the organisation is in the role of the represented and the person the
representative. The purpose field is also mapped to the relationship. The Contact resource
component has its own set of telecoms and addresses, mapped in the same manner as before.
The name field is of the FHIR HumanName data type, which maps to the PersonName archetype.</p>
      </sec>
      <sec id="sec-6-2">
        <title>6.2. Specimen</title>
        <p>The FHIR Specimen resource can be thought of as an item used by a healthcare institution to
provide medical care. Perhaps it is analysed to give a diagnosis and assign proper treatment to
a patient. Taking that into consideration, as a business archetype, a Specimen resource is an
instance of a Product of the specimen type. In FHIR, the Specimen resource is a composition
of containers that all contain the same type of sample. This can be modelled with business
archetypes in the following manner. The specimen is an instance of the Package archetype (a
subclass of the Product archetype) that contains instances of the Container archetype. Each
Container contains a specified amount of the sample that is described using the MeasuredProduct
archetype. The parent object in this construct is the Package archetype. The identifiers and
accessionIdentifier fields of the Specimen resource are tied to the instance of the Package archetype
with the RegisteredIdentifier archetype. The accessionIdentifier is singled out from the other
identifiers using a Feature archetype connected to the Package. The status field of the Specimen
resource is mapped to the ReservationStatus value of the Package archetype. The receivedTime
ifeld of the Specimen resource maps to the ValidFrom value of the Package archetype. This is
illustrated in Figure 10. The FHIR Identifier data type mapping is exactly the same as that of the
Organisation resource 7. The Specimen resource contains many fields that can be abstracted to
specifications about the Package. With business archetypes, these specifications are modelled
with the Feature archetype. A Feature has a type and a value. The segments of the Specimen
resource that can be mapped to Features are the subject, parent, request, condition and note fields.
The first three are Reference data types, which simply point to another resource in a system.
Since these fields are not instances of other resources, the Feature archetype is the perfect fit.
The mapping of these fields to the Feature archetype can be seen in Figure 11. Each Container
component of the Specimen resource is an instance of the Container archetype, which is also a
subclass of the Product archetype. The Container components type maps to the ContainerType
archetype. The Container components capacity field is a Feature. The Container component also
holds information about the sample inside it. This is mapped to the MeasuredProduct archetype,
another subclass of the Product archetype. The type of MeasuredProduct is specified in the type
ifeld of the Specimen resource because this is the type of sample. All of this is illustrated in
Figure 12. The Processing components and the Collection component of the Specimen resource
can be thought of as specifications of the specimen. Each Processing component maps to a single</p>
        <p>Feature archetype instance and the Collection component maps to a set of Feature archetypes.</p>
      </sec>
    </sec>
    <sec id="sec-7">
      <title>7. Evaluation and discussion</title>
      <sec id="sec-7-1">
        <title>7.1. Business archetypes as FHIR meta-models</title>
        <p>The information gathered from the mapping performed during the development of the initial
proof-of-concept yields that it is most likely possible to map the entire HL7 FHIR specification
to the business archetypes meta-models, though more resources should be examined to say this
with certainty.</p>
        <p>This activity is a great way to validate the business archetype patterns as a SUM for FHIR
models. Even with only two resources, the possible shortcomings of the abstraction the
metamodels provide were highlighted. The troubles were mainly caused by FHIR’s use of complex
data types (e.g. Identifier , Reference and CodeableConcept), while the meta-models rely on
objectrelational patterns instead. A data type needs to be deconstructed and mapped to a semantically
suitable archetype in the context of the resource’s matching archetype pattern; there is no
one-fits-all matching business archetype for a complex FHIR data type in each case.</p>
        <p>When sending example messages to the deployed FHIR endpoint, it is transformed and
inserted into the ABC4HEDA database. When requesting the data back from ABC4HEDA in
the FHIR format, we are given a response that contains all meaningful data from the inserted
message. Diferences in the processed FHIR message only include content that is maintained by
the infrastructure or content that can be generated from data already included in the message.</p>
      </sec>
      <sec id="sec-7-2">
        <title>7.2. Mirth Connect as an integration engine</title>
        <p>The value of Mirth Connect as a tool mainly resides in its ability to decouple the integration
from the systems themselves. Another great feature is the extensibility of the engine. Custom
code libraries can be written in the Mirth Connect Administrator application, but it is also
possible to import Java libraries via .jar files. That being said, it is evident that Mirth Connect
is mostly a tool for a developer, not an analyst, and substantial outside tooling is required to
make integrating systems a decent experience. The use of open-source HAPI FHIR API Java
packages makes the development of this proof-of-concept considerably easier from the FHIR
side. As the meta-models lack a web programming interface of any kind, development was quite
cumbersome, therefore mapping the entire FHIR standard in this manner is not feasible. The
integration for the Organisation resource took a little over 600 lines of code and the Specimen
resource a little under 800 lines of code. Clean Code [16] paradigms were mostly adhered to.</p>
        <p>However, reasonable requirements for the tools needed for any kind of integration with the
meta-models were gathered in the course of this proof-of-concept. For example, the meta-models
would greatly benefit from a GraphQL API. The integration process would go from programming
a set of SQL statements to designing a single GraphQL query for a FHIR resource, which could
then be reused for both requesting and mutating data. Combining GraphQL and FHIR has shown
promising results in the past [17, 18]. Another necessary element to enabling data exchange
between models is a web service to query classifier identifiers. An example use case is sending
the service a request with the SNOMED code ’119364003’ and the response then containing
the unique system identifier of this classifier in the ABC4HEDA database, thus allowing the
creation of valid object relationships. We believe that a large volume of integration code could
be extracted to a common library of utility methods regarding the business archetypes. At scale,
this could help reduce the code needed for integrating any one FHIR resource substantially.</p>
      </sec>
      <sec id="sec-7-3">
        <title>7.3. Further work</title>
        <p>Formalising the FHIR models and value sets in the meta-models is another critical step in
validating and integrating the specification with business archetypes. The model formalisation
is the medical knowledge of the specification, while transforming information between the
formats concerns only the medical data.</p>
        <p>Further work also includes prototyping and validating the tooling mentioned in the previous
subsection. Perhaps a minimal GraphQL implementation spanning parts of the Product archetype
pattern could be developed to rewrite the Specimen resource mapping and then compared with
this proof-of-concept. Ideally, it would be possible for the logical mapping between specifications
of health data to be done by an analyst in a low-code/no-code manner. In their current state,
the meta-models are not suficient in this regard. A GraphQL API for business archetypes
could enable the development or use of an analyst-friendly mapping language and source code
generators for the implementation of the integration, drawing inspiration from work regarding
GraphQL and federated interoperability in [19].</p>
        <p>This work could also be used as a basis for developing similar knowledge of integration and
formalising other standardised healthcare data models, such as those used by HL7 v2.x, HL7
v3.x and openEHR. Alternative tools to Mirth Connect are also worth investigating.</p>
      </sec>
    </sec>
    <sec id="sec-8">
      <title>8. Conclusion</title>
      <p>We think mapping the entire HL7 FHIR specification to the business archetypes meta-models is
possible. Therefore, semantic interoperability between the meta-models and FHIR-based systems
is entirely implementable, though some additional tooling would make the development process
much easier. In addition, Mirth Connect is a great candidate for implementing integration
beyond this proof-of-concept, though it would most likely have to be done by a software
developer, not an analyst.</p>
      <p>This paper can be used as a starting point to implement integration tooling for ABC4HEDA,
formalising the FHIR specification in business archetypes and researching other healthcare data
model standards.</p>
      <sec id="sec-8-1">
        <title>Authors’ contribution</title>
        <p>Rainer Randmaa wrote the manuscript with support from Igor Bossenko, Toomas Klementi and
Gunnar Piho. All authors contributed to the final version of the manuscript. Gunnar Piho and
Peeter Ross supervised the project.</p>
      </sec>
      <sec id="sec-8-2">
        <title>Acknowledgments</title>
        <p>This work in the project ’ICT programme’ was supported by the European Union through the
European Social Fund.</p>
      </sec>
    </sec>
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