=Paper= {{Paper |id=Vol-2454/paper_55 |storemode=property |title=Ontology-Based Privacy Compliance Checking for Clinical Workflows |pdfUrl=https://ceur-ws.org/Vol-2454/paper_55.pdf |volume=Vol-2454 |authors=Saliha Irem Besik,Johann-Christoph Freytag |dblpUrl=https://dblp.org/rec/conf/lwa/BesikF19 }} ==Ontology-Based Privacy Compliance Checking for Clinical Workflows== https://ceur-ws.org/Vol-2454/paper_55.pdf
    Ontology-Based Privacy Compliance Checking
               for Clinical Workflows

               Saliha Irem Besik and Johann-Christoph Freytag

        Humboldt-Universität zu Berlin, Department of Computer Science,
                 Unter den Linden 6, 10099 Berlin, Germany
               {besiksal,freytag}@informatik.hu-berlin.de




      Abstract. Data privacy is an essential human right to determine what,
      when, and how personal data is communicated to various recipients. In
      the healthcare domain, it is an important and challenging issue how to
      safeguard data privacy of patients. Healthcare providers have to pro-
      cess sensitive medical data compliantly with binding privacy regulations
      such as the European Union General Data Protection Regulation. Clin-
      ical workflows play an important role in healthcare domain by outlining
      the tasks must be done for the delivery of clinical services. However, in
      general, they do not support privacy constraints in an adequate way.
      In this paper, we propose an ontology-based privacy compliance check
      approach to detect the possible privacy violations in clinical workflows.
      In order to analyze the potential applicability of our methodology, we
      describe a Newborn Screening scenario where we show how to apply
      semantic reasoning to support building privacy-awareness.

      Keywords: Data Privacy · General Data Protection Regulation (GDPR)
      · Privacy Policies · Privacy Preferences · Ontology · Ontology Reasoning
      · Business Process Compliance


1    Introduction
The European Union General Data Protection Regulation (GDPR) has come
into force very recently to protect data privacy of all individuals within the
European Union [1]. “Privacy by Design”(PbD) is a core principle according to
the GDPR and it obliges the organizations to proactively embed privacy into
their technology design [GDPR, Article 23].
    In order to support PbD, the organizations can greatly benefit from the busi-
ness process models via checking privacy compliance of their business process
models during the design time. Business process modeling and management are
mostly based on a control-flow-centric perspective which emphasizes on the se-
quencing of activities with ignoring the data aspects. However, we believe that
business process models can also be considered as a means to capture how data
   Copyright c 2019 for this paper by its authors. Use permitted under Creative
Commons License Attribution 4.0 International (CC BY 4.0).
2      S.I. Besik and J.C. Freytag

is transmitted by whom and for what purpose at the conceptual level. Busi-
ness process models are usually captured using the Business Process Model and
Notation (BPMN), hence, we use BPMN to model clinical workflows.
    We represent privacy-awareness for the clinical workflows not only in terms
of the regulatory compliance with the GDPR and the privacy policies of health-
care providers, but also in terms of the compliance with the privacy preferences
of patients when sharing and/or processing their personal data. We have used
an ontology-based reasoner to verify privacy compliance. Ontology development
contributes to our research significantly in terms of sharing a common under-
standing among different domains, namely business process modeling, privacy,
and clinical domains.
    In this paper, we present our Privacy-aware Clinical Workflow (PaCW) on-
tology and we give a running example which is related to the newborn screening
procedure applied in Germany to show how our reasoning approach works. We
selected the clinical workflows as a case study because privacy in the clinical
domain is particularly significant due to the high sensitivity of “data concerning
health”. However, our proposed approach is domain-independent and can thus
be applied to any other domain.
    The rest of this paper is organized as follows: Section 2 explains our Privacy-
aware Clinical Workflow (PaCW) Ontology in detail. Section 3 presents our rea-
soning approach to check privacy compliance and discusses the implementation
details. Section 4 gives a running example in the clinical domain in order to show
the usability of our reasoning approach. Section 5 reviews related works. Finally,
Section 6 concludes this paper and discusses our future work and perspectives.


2     Privacy-aware Clinical Workflow (PaCW) Ontology

Our research brings business process modeling, data privacy, and clinical do-
mains together. We used ontologies to bridge the gap and share a common un-
derstanding of these domains. We developed the Privacy-aware Clinical Workflow
(PaCW) Ontology which consists of three ontologies which are Privacy Ontol-
ogy, BPMN Ontology, and Clinical Domain Ontology. In this section, we propose
Privacy Ontology and BPMN Ontology, as well as the mappings between them.
We explain Clinical Domain Ontology while presenting our running example. We
have developed our ontologies through the Unified Modeling Language (UML).


2.1   Privacy Ontology

Privacy compliance is mostly defined as a stakeholder’s accordance with estab-
lished privacy policies and/or privacy regulations. We argue that privacy compli-
ance has a broader definition considering also the data owners’ (data subjects’)
personal privacy preferences. In this regard, we define “privacy-awareness” for
clinical workflows as the compliance both with the privacy principles based on
the GDPR and the privacy policies provided by healthcare providers, as well
       Ontology-Based Privacy Compliance Checking for Clinical Workflows         3

as the compliance with the privacy preferences of patients on sharing or pro-
cessing their personal medical data. In this section, we briefly introduce these
three sources which contribute to our privacy-awareness definition and then we
present our Privacy Ontology.

Privacy Principles based on the GDPR We have introduced the found-
ing privacy principles for clinical workflows on the ground of the GDPR. Even
though we have focused on the GDPR, we believe these principles are also rele-
vant and valuable for other regulations.

1- Purpose Specification: “Personal data shall be collected for specified, ex-
plicit and legitimate purposes and not further processed in a manner that is
incompatible with those purposes [...]” [Article 5, §1(b)]
2- Data Minimization: “Personal data shall be adequate, relevant and limited
to what is necessary in relation to the purposes for which they are processed.”
[Article 5, §1(c)]
3- Consent Check: “Processing shall be lawful if the data subject has given
consent to the processing of his or her personal data for one or more specific
purposes.” [Article 6, §1(a)]
4- Limited Retention Period: “Personal data shall be kept in a form which
permits identification of data subjects for no longer than is necessary for the
purposes for which the personal data are processed [...]” [Article 5, §1(e)]
    In summary, for data operations to be GDPR compliant:
 1. data must be processed for a specified purpose,
 2. the data owner has consented -unless the specific conditions such as “vital
    interest” or “public interest” are met for lawful processing-[Article 6],
 3. be necessary to achieve the specified purpose,
 4. and data must be erased when it is no longer necessary for the given purpose.

Privacy Policies According to the GDPR, service providers have to inform the
data subjects about how their personal data is being used by specifying privacy
policies. A privacy policy document is a high-level natural language description
of the privacy practices of a service provider. Privacy policies describe what data
is used, for what purpose and by whom, as well as how long the data will be
retained. They might also contain the modality of data processing, whether it
requires explicit consent or not.

Privacy Preferences We have constructed our privacy preference formulation
based on Alan Westin’s definition of privacy. In his well-known book Privacy
and Freedom, he defines privacy in terms of self-determination: “Privacy is right
on decision of every individual: when, how and how much information will be
available for storing and exchange between systems.” [2]. Therefore, we express
privacy preferences as the right of data subjects to determine who can access
their personal data and for what purposes.
4      S.I. Besik and J.C. Freytag

                   Purpose                                               PrivacyRule

            +purposeName: String                                   +purpose: Purpose




                ConsentPolicy
                                                        PolicyRule                     PreferenceRule
            +requiresConsent: bool
                                                                                +dataSubject: DataSubject
                                                                                +user: User
            DataMinimizationPolicy                   RetentionPolicy            +data: Data
                                                                                +duration: String
            +userRole: String                       +data: Data                 +condition: bool
            +data: List                       +retention: String          +status: bool
            +condition: bool




                      User                            Data                             DataSubject

            +userName: String                +dataName: String              +dataSubjectName: String
            +userRole: String                +dataCategory: String          +prefList: List 




                             Directed Association               Association               Generalization
            Legend:




                  Fig. 1. The main components of privacy ontology.


    We built privacy ontology according to these three sources. Figure 1 il-
lustrates the main components of the privacy ontology: Both privacy policy
statements (PolicyRule) and privacy preferences (PreferenceRule) are de-
fined as PrivacyRule. Privacy rules are all purpose-focused, hence they are
associated with the Purpose ontology class which specifies the reason for which
data is collected, used, or disclosed. PolicyRule class has three sub-classes:
ConsentPolicy ontology class defines which kind of Purpose instances require
explicit consent. RetentionPolicy declares the retention period of data prac-
tices. DataMinimizationPolicy expresses the amount of personal data which
should be revealed and processed by the users in different conditions. User is
the set of individuals or organizations who accesses the personal data. Data is
categorized to adopt the right privacy measures suitable for the type of data to
be protected. We have used different data categories which are defined in the
GDPR (personal data, sensitive data, identification data, anonymous data, pub-
lic data, etc.) DataSubject refers to any individual person who can be identified.
prefList represents a list of PreferenceRule.

2.2   BPMN Ontology
The Business Process Model and Notation (BPMN) is a widely used standard
for business process modeling and also maintained by the Object Management
Group (OMG). Therefore, we have selected BPMN 2.0 as the modeling notation
for the clinical workflows.
    Figure 2 shows the graphical representation of the core BPMN elements used
in our clinical workflows. We have adapted the BPMN 2.0 Ontology presented
in [3] to semantically represent these core BPMN elements.
              Ontology-Based Privacy Compliance Checking for Clinical Workflows                                                                    5


                                     Task




                                                                                            Pool
                                                        Start Event         End Event




                                                                                                   Lane




                                                                                                          Annotation
                                                                                            Data




                                                                                                            Text
                                                                               Data
                                 Exclusive     Parallel       Inclusive                    Object
                                                                               Store
                                 Gateway       Gateway        Gateway




                                Sequence Flow        Message Flow           Data Association        Association




                                              Fig. 2. Core BPMN elements.


   Data privacy in clinical workflows is a subject of how data is handled in
BPMN. Therefore, we have worked on different ways of data handling supported
in BPMN (shown in Table 1) and we created new ontology classes to support
data privacy in clinical workflows accordingly.
   Figure 3 illustrates the main components of our BPMN ontology. It presents
the important attributes and operations of the ontology classes and “is-a” hi-
erarchy (generalization) among them. We omitted the association relations for
the sake of illustration (except the one between BPMNModel and BPMNElement).


                                                                   BPMNModel

                                                        +elementList: List 


                                                                BPMNElement


                                      Node                    TextAnnotation                       Edge                          SequenceFlow
         InteractionNode

                                                            +text: String                                                   +getSource(): FlowNode
                                                                                                                            +getTarget: FlowNode
                                                                                            DataHandler
                                   BaseElement
      Pool                                                   DataAnnotation
                                                                                   +getAnnotation(): DataAnnotation
                                +belongsTo(): Lane
+userRole: String                                          +purpose: Purpose
                                                           +data: List 
                                                                                                                                Association
                                                           +hasPurpose(): bool
       Lane                                                +hasData(): bool                                             +getSource(): BPMNElement
                                   FlowNode                                                                             +getTarget(): BPMNElement
+userRole: String                                    BPMNData
+belongsTo(): Pool                                                                                                             MessageFlow
                                                                      DataStore
                                                     DataObject                          DataAssociation               +getSource(): InteractionNode
                                                                                                                       +getTarget(): InteractionNode
 StartEvent
                        Event        Task     Gateway

                                                                Exclusive
 EndEvent
                                                                                  DataInputAssociation                  DataOutputAssociation
                    DataOperationTask
                                                                              +getSource(): BPMNData          +getSource(): DataOperationTask
                    +haveConsent(): bool     Parallel         Inclusive       +getTarget(): DataOperationTask +getTarget(): BPMNData




                                Fig. 3. The main components of BPMN ontology.


    The ontology classes for the core BPMN elements are adapted from BPMN
2.0 Ontology [3]. The newly created ontology classes to support privacy-awareness
6         S.I. Besik and J.C. Freytag




    Data Flow                      Graphical Representation                  Meaning


                                                                   The task retrieves information
    Data Association                                    Task
                         Data Store                                from the data store



                                                                   The task writes information
    Data Association                                    Task
                         Data Store                                to the data store



                                                                   Task A writes information to
                                           Data Store
                                                                   the data store and Task B
    Association
                                                                   retrieves information from the
                                  Task A                  Task B   data store



    Data Association     Data                                      The task receives data object
                                                        Task
                        Object




    Data Association     Data                                      The task sends data object
                                                        Task
                        Object



                                               Data
                                              Object
                                                                   Task A sends data object and
    Association                                                    Task B receives data object
                                  Task A                  Task B
                         Lane A




                                                                   Lane A sends message to Lane B
    Message Flow                                                   in other words Lane B receives
                                                                   message from Lane A
                         Lane B




                              Table 1. Data Handling in BPMN
       Ontology-Based Privacy Compliance Checking for Clinical Workflows                               7

in clinical workflows are DataOperationTask, DataHandler, and DataAnnotation.
DataOperationTask is a type of Task which has a data association. As it is il-
lustrated in Table 1, data is generally handled either via DataAssociation or
via MessageFlow. Alternatively, data may be directly associated with a sequence
flow via Association. DataAnnotation is a type of TextAnnotation. We as-
sume that for each data operation in a BPMN workflow, it is known which data
is used for which purpose explicitly. For this we use DataAnnotation, where
purpose referring to the purpose of accessing data and data referring to a set of
data which is accessed. DataOperationTask has haveConsent() function which
aims to find out whether a data operation task has consented. The attributes
written in red indicate that they are associated with the ontology classes from
Privacy Ontology. The foundational components of Privacy Ontology, namely
User, Data, and Purpose are represented in clinical workflows via a set of BPMN
constructs. User is mapped onto the BPMN Pool and Lane elements. Data and
Purpose are represented via the BPMN Data Annotation element.


                                                   PaCW: Ontology Stack
                                                          (UML)


                                                 BPMN
                                                Ontology


                                                              Clinical
                                     Privacy                 Domain
                                     Ontology                Ontology




                Clinical                                                  Privacy           Privacy
               Workflow                  (1) UML to Java Classes           Policy         Preference
              (BPMN 2.0)




           (2) Transform into                                               (3) Create Privacy Rule
        BPMNModel Java Instance             PaCW Ontology                       Java Instances
                                            (Java Classes)




              BPMNModel                         Rule Base                         PrivacyRule
            (Java Instance)                      (DRL)                          (Java Instance)




                                     Reasoner for Compliance Check
                                          (Drools Rule Engine)




                                         (4) Execute Reasoner




                                        result (compliant or not)



                                  Fig. 4. Reasoning Approach.
8        S.I. Besik and J.C. Freytag

3       Reasoning Approach and Implementation Details

Figure 4 gives an overview of our reasoning setting. The implementation steps
can be summarized as follows:
(1) Transform UML ontology classes to Java classes: We worked with
Eclipse Modeling Framework to be able to manipulate the instances of BPMN 2.0
and UML ontology. We used UML as an ontology developing language because
it is widely adopted by the software engineering community and Eclipse provides
an automatic transformation library from UML to Java programming language
(Eclipse UML Generators1 ) We created Java classes regarding for each ontology
classes in our PaCW ontology. For instance; below you can see the Java class
for the ConsentPolicy ontology class after the transformation by the UML
Generator.

public class ConsentPolicy extends PolicyRule {
   private boolean requiresConsent;
   /* getter and setter functions*/
   // Constructor
   public ConsentPolicy(Purpose p, boolean requiresConsent){
      super (p);
      this.requiresConsent = requiresConsent;
   }
}

(2) Parse Clinical Workflow and Create a BPMNModel Instance accord-
ingly: Our input clinical workflows are in BPMN 2.0 format. In order to parse
these files, we used Camunda BPMN Model API2 . We accessed the BPMN el-
ements via this Java library and we created BPMNModel Java Class instance by
using the constructor of BPMNModel ontology class.
(3) Create Privacy Rule Instances: Our privacy rules are coming from ei-
ther privacy policies or privacy preferences. We created PrivacyPolicy and
PrivacyPreference Java Class instances by using the constructors of these on-
tology classes. For instance; below you can see a Java class instance for the
ConsentPolicy ontology class.

public class PrivacyRuleInstances{
   ConsentPolicy p1 = new ConsentPolicy (new
       Purpose("hearing-screening"), true);
}

(4) Execute Compliance Check Rules via Rule Engine: We implemented
our rule engine by using Drools Business Rule Engine.3 Eclipse offers a plugin for
Drools which offers a development environment for rules manipulation. Drools

    1
      https://eclipse.org/umlgen/.
    2
      https://docs.camunda.org/manual/7.7/user-guide/model-api/bpmn-model-api/.
    3
      https://www.drools.org/.
       Ontology-Based Privacy Compliance Checking for Clinical Workflows              9

is a Java-based open source business rule management system with a forward-
chaining and backward-chaining inference based rules engine. Drools has its own
rule language called Drools Rule Language (DRL). In DRL syntax, every rule
has a “when” section which defines the conditions to be fulfilled to trigger the
rule and a “then” section which defines the actions to be executed when the
rule is triggered. DRL uses instances of Java classes, thus all concepts in the
UML ontology are represented as plain Java classes. We created compliance
rules regarding each privacy principles which we have proposed. Below, you can
find two examples of DRL rules as “Purpose-Specification-Check” and “Consent-
Check” DRL rules. “Purpose-Specification-Check” checks for each DataHandler
whether there is a data annotation. It also finds out whether the data annotations
have a purpose. If there is no data annotation or if there is no purpose for the
data annotation, the rule gives a failure message.

rule "Purpose-Specification-Check"
   when
      BPMNModel.DataHandler(!hasDataAnnotation() ||
          !dataAnnotation.hasPurpose())
   then
      System.out.println("Compliance Check fail: Purpose-Specification");
   end

   “Consent-Check” DRL rule checks whether the data associations requiring
consent according to privacy policy rules have consented in the BPMN model.
For this purpose, we use haveConsent function. It searches whether the con-
sent check pattern (illustrated in Figure 5) precedes the data associations. If
haveConsent function does not encounter the consent check pattern preceding
a data association, DRL rule returns a failure message.



                                                 yes        Data Operation
                check consent                                Task requiring
                                             <>
                                                                consent



                           d: consent                                    d: data
                           p: purpose                                    p: purpose



                    data                                         data




                                Fig. 5. Consent Check Pattern



rule "Consent-Check"
   when
      ConsentPolicy(requiresConsent = true, $p: purpose)
      BPMNModel.DataInputAssociation ($d: dataAnnotation, $d.getPurpose()
          = $p, !source.haveConsent()) ||
10       S.I. Besik and J.C. Freytag

        BPMNModel.DataOutputAssociation ($d: dataAnnotation, $d.getPurpose
            = $p, !target.haveConsent())
     then
        System.out.println("Compliance Check fail: Consent-Check");
     end




4     A Running Example


                                                                                                                                                  Clinical Ontology
                                                                                                   Data                                Purpose
                     User



                                                                                            Medical Data
               Medical Staff                                                                                                          Screening



                                                                                   Hear Screening           Hear
                                                                                                          Screening                     Hear
                  Pediatrician                                                      Medical Data
                                                                                                           Result                     Screening



                                                                                                                                                  Privacy Ontology
                    User
                                                                                           Purpose1
                                                                   Purpose
                                                                                      name=hear screening


                 User1                                                                       Data
            role=pediatrician

                                               Data1                                                                             Data2
                                                                                                                          name=hear screening
                                       name=hear screening
                                                                                                                          result
                                       medical data



                                                                                                                                                  BPMN Ontology
                                                                                   TextAnnotation




                                                                                   DataAnnotation
                                         DataAnnotation1
                                     purpose=hear screening                                                                  DataAnnotation2
                                     data= {hear screening                                                               purpose=hear screening
                                     medical data}                                                        DataStore      data= {result}
                                                                                              Task
           Lane
                                 StartEvent                        SequenceFlow                                                                        EndEvent
                                                                                                                 DataAssociation

               Lane1
          name=pediatrician        StartEvent1               SequenceFlow1 DataAssociation1 Task1         DataStore1   SequenceFlow2 DataAssociation2 EndEvent1




                                                                                      perform hearing
                                                                                         screening
                                              pediatrician




                                                               newborn arrives


                                                               p:hear screening,                                p:hear screening,
                                                               d:hear screening                                 d:hear screening
                                                               medical data                                     result

                                                                                            HIS



                                                                                                                                                             Legend

              UML Instance                                   UML Class                   Mapping                       Type                Class Hierarchy




      Fig. 6. The mapping between a sample BPMN Model and PaCW Ontology.


    Figure 6 illustrates a simple BPMN model for a newborn hearing screening
procedure. It also shows the mappings when we parse this model and create a
BPMNModel instance accordingly. The mapping include some concepts from Clin-
ical Ontology. For instance, according to the ontology pediatrician is a medical
       Ontology-Based Privacy Compliance Checking for Clinical Workflows        11

staff. When a privacy rule is regarding medical staff as user, it is also about its
subclasses including pediatrician.
    In order to check privacy compliance, the compliance rules given in DRL
are executed. In this section, we look at the compliance with the “Purpose-
Specification-Check” and “Consent-Check” DRL rules. In the running exam-
ple, there are two data associations which are also DataHandler. “Purpose-
Specification-Check” rule checks the failure cases. It checks both data associa-
tions whether they have DataAnnotation and whether their data annotations
have a purpose. Since both of the conditions return false, “then” part is not ex-
ecuted. Hence, compliance check for the purpose principle succeeds. Both data
associations require consent according to the consent policy which we have shown
as privacy rule instance. “Consent-Check” DRL rule checks both data associa-
tions whether they have consented. haveConsent function searches whether the
consent check pattern precedes data associations. Since the condition is satisfied,
compliance rule for the consent check returns true and it gives a failure message.



5   Related Work

Our research provides a holistic approach by combining privacy, business pro-
cesses, and ontologies. We grouped the related works into three research areas:

 1. Privacy in Business Processes: [4][5][6] propose BPMN extensions in
    order to capture the security and privacy needs. These works are focused
    on modeling privacy into business processes; however, they do not represent
    any reasoning to enforce privacy constraints. [7] introduces a framework
    for enforcing data privacy in the context of Data Analysis Workflows. It
    provides an ontology to incorporate the Data Analysis workflows and tra-
    ditional privacy-preserving algorithms. Their privacy definition significantly
    differs from our definition because they focus only on privacy-preserving
    algorithms, not the regulatory compliance.
 2. Semantic Approaches in Business Process Compliance: [8] proposes
    an ontology-based approach to detect possible semantic errors in business
    processes designed by using Coloured Petri Net (CPN). The work represents
    the business ontology in Ontology Web Language (OWL) and the business
    rules in Semantic Web Rule Language (SWRL). It checks the compliance
    in between through a reasoner. [9] checks the semantic correctness of CPN
    processes with the SPARQL query language. However, these works do not
    include privacy.
 3. Semantic Approach for Privacy Compliance: Rahmouni et al. built an
    ontology of privacy requirements for sharing medical data between different
    healthcare organizations in European countries [10]. Belaazi et al. provide an
    ontology-based approach for access control [11]. These works do not include
    business processes.
12      S.I. Besik and J.C. Freytag

6    Conclusion and Future Work
In this paper, we introduced our Privacy-aware Clinical Workflow (PaCW) on-
tology and we provided our semantic reasoning approach for privacy compliance
through a running example from the clinical domain. Our focus was detecting
privacy violation via ontology-based reasoning. As a future work, we are also
interested in providing corrective actions in terms of how to fix the causes of
violation and transform the non-privacy-aware workflow into a privacy-aware
workflow accordingly.


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