Functional Requirements for Medical Data Integration into Knowledge Management Environments: Requirements Elicitation Approach Based on Systematic Literature Analysis

Background: In patient care, data are historically generated and stored in heterogeneous databases that are domain specific and often noninteroperable or isolated. As the amount of health data increases, the number of isolated data silos is also expected to grow, limiting the accessibility of the collected data. Medical informatics is developing ways to move from siloed data to a more harmonized arrangement in information architectures. This paradigm shift will allow future research to integrate medical data at various levels and from various sources. Currently, comprehensive requirements engineering is working on data integration projects in both patient care- and research-oriented contexts, and it is significantly contributing to the success of such projects. In addition to various stakeholder-based methods, document-based requirement elicitation is a valid method for improving the scope and quality of requirements. Objective: Our main objective was to provide a general catalog of functional requirements for integrating medical data into knowledge management environments. We aimed to identify where integration projects intersect to derive consistent and representative functional requirements from the literature. On the basis of these findings, we identified which functional requirements for data integration exist in the literature and thus provide a general catalog of requirements. Methods: This work began by conducting a literature-based requirement elicitation based on a broad requirement engineering approach. Thus, in the first step, we performed a web-based systematic literature review to identify published articles that dealt with the requirements for medical data integration. We identified and analyzed the available literature by applying the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. In the second step, we screened the results for functional requirements using the requirements engineering method of document analysis and derived the requirements into a uniform requirement syntax. Finally, we classified the elicited requirements into a category scheme that represents the data life cycle. Results: Our 2-step requirements elicitation approach yielded 821 articles, of which 61 (7.4%) were included in the requirement elicitation process. There, we identified 220 requirements, which were covered by 314 references. We assigned the requirements to different data life cycle categories as follows: 25% (55/220) to data acquisition, 35.9% (79/220) to data processing, 12.7% (28/220) to data storage, 9.1% (20/220) to data analysis, 6.4% (14/220) to metadata management, 2.3% (5/220) to data lineage, 3.2% (7/220) to data traceability, and 5.5% (12/220) to data security. Conclusions: The aim of this study was to present a cross-section of functional data integration-related requirements defined in the literature by other researchers. The aim was achieved with 220 distinct requirements from 61 publications. We concluded that scientific publications are, in principle, a reliable source of information for functional requirements with respect to medical data integration. Finally, we provide a broad catalog to support other scientists in the requirement elicitation phase.