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Observational studies and clinical trials have become increasingly important over recent years and play an essential role in advancing medical knowledge. In today’s world of clinical research, it is not possible to imagine trials without the founda-tion of a well-established it-infrastructure. Electronic capture and usage of data is pervasive.
In practice, medical progress requires the ability to integrate data from different systems. An essential factor in enabling different actors, such as institutions and hospitals, to have their systems exchange structured data and make use of the information is the interoperability of the data and systems.
FHIR (Fast Healthcare Interoperable Resources) is a free and easily customizable HL7 platform standard, based on 30 years of experience of HL7. It is focused on providing health-related information and defines a set of capabilities used in the health care process.
This thesis will provide a conceptual approach for working with FHIR, as well as concrete approaches for working with FHIR profiles and for customizing the standard for particular use cases. It will be carried out in cooperation with the Medical Systems R&D, which is a service provider within the University Hospital of Cologne.
The guiding request approach will focus on the evaluation of requirements for clini-cal trials and how clinical research protocols can be represented in an interoperable and machine-parsable format using FHIR.
Objectives FHIR (Fast Healthcare Interoperability Resources) is an emerging Stan¬dard for improving interoperability in the domain of health care. Besides offering features for achieving syntactical, semantical and organizational interoperability, it also specifies a RESTful API for searching purposes. The main objective of the following thesis revolves around investigating open challenges and limitations of the so-called FHIR Search Framework.
Methods A variety of operations for searching in FHIR resources, including all search interactions, definitions of search parameters, search parameter types and advanced search concepts are described. Over the course of the thesis, a quality model based on ISO 25010 is established. It serves as the foundation for determining if the FHIR Search Framework is well-suited to cover the Information needs of its users. An analysis of completeness involving the measures defined in the quality model forms the main contribution. The primary discussion of the research questions is concluded by proposing a graph model for determining reachability between FHIR resources, essentially mirroring the chaining and reverse chaining functionality. Using well-known classes for expressiveness in graphs, the thesis assess to which degree a graph search can be formulated with the currently defined capabilities.
Results From a functional perspective the FHIR Search Framework can be considered well-suited. Practical limitations should be minimal, grounded on the fact that extensive coverage of the lowest expressiveness classes, RPQs and 2RPQs, can be achieved. Severe gaps where identified only in the support of C(2)RPQs and Data Path Queries. Additionally, ideas for improving non-functional aspects are introduced to support developers in learning the Standard and testing their implementations.
Conclusion The evaluation of the FHIR Search Framework showed promising re¬sults in terms of functional completeness. Yet, the Standard is still evolving, and certain parts of the Search API are neither well-known nor implemented widely. A discussion is to be held if the specification should cover more sophisticated aspects that result from the gaps which were identified.