FAIRness through automation: development of an automated medical data integration infrastructure for FAIR health data in a maximum care university hospital.

BACKGROUND: Secondary use of routine medical data is key to large-scale clinical and health services research. In a maximum care hospital, the volume of data generated exceeds the limits of big data on a daily basis. This so-called "real world data" are essential to complement knowledge and results from clinical trials. Furthermore, big data may help in establishing precision medicine. However, manual data extraction and annotation workflows to transfer routine data into research data would be complex and inefficient. Generally, best practices for managing research data focus on data output rather than the entire data journey from primary sources to analysis. To eventually make routinely collected data usable and available for research, many hurdles have to be overcome. In this work, we present the implementation of an automated framework for timely processing of clinical care data including free texts and genetic data (non-structured data) and centralized storage as Findable, Accessible, Interoperable, Reusable (FAIR) research data in a maximum care university hospital. METHODS: We identify data processing workflows necessary to operate a medical research data service unit in a maximum care hospital. We decompose structurally equal tasks into elementary sub-processes and propose a framework for general data processing. We base our processes on open-source software-components and, where necessary, custom-built generic tools. RESULTS: We demonstrate the application of our proposed framework in practice by describing its use in our Medical Data Integration Center (MeDIC). Our microservices-based and fully open-source data processing automation framework incorporates a complete recording of data management and manipulation activities. The prototype implementation also includes a metadata schema for data provenance and a process validation concept. All requirements of a MeDIC are orchestrated within the proposed framework: Data input from many heterogeneous sources, pseudonymization and harmonization, integration in a data warehouse and finally possibilities for extraction or aggregation of data for research purposes according to data protection requirements. CONCLUSION: Though the framework is not a panacea for bringing routine-based research data into compliance with FAIR principles, it provides a much-needed possibility to process data in a fully automated, traceable, and reproducible manner.

Provenance Solutions for Medical Research in Heterogeneous IT-Infrastructure: An Implementation Roadmap.

Research data generated in large projects raise challenges about not only data analytics but also data quality assessments and data governance. The provenance of a data set - that is the history of data sets - holds information relevant to technicians and non-technicians and is able to answer questions regarding data quality, transparency, and more. We propose an implementation roadmap to extract, store, and utilize provenance records in order to make provenance available to data analysts, research subjects, privacy officers, and machines (machine readability). Each aspect is tackled separately, resulting in the implementation of a provenance toolbox. We aim to do so within the context of HiGHmed, a research consortium established within the medical informatics initiative in Germany. In this testbed of federated IT-infrastructures, the toolbox shall assist each stakeholder in answering domain-specific and domain-agnostic questions regarding the provenance of data sets. This way, we will improve data re-use, transparency, and reproducibility.

Applying FAIRness: Redesigning a Biomedical Informatics Research Data Management Pipeline.

BACKGROUND: Managing research data in biomedical informatics research requires solid data governance rules to guarantee sustainable operation, as it generally involves several professions and multiple sites. As every discipline involved in biomedical research applies its own set of tools and methods, research data as well as applied methods tend to branch out into numerous intermediate and output data objects, making it very difficult to reproduce research results. OBJECTIVES: This article gives an overview of our implementation status applying the Findability, Accessibility, Interoperability and Reusability (FAIR) Guiding Principles for scientific data management and stewardship onto our research data management pipeline focusing on the software tools that are in use. METHODS: We analyzed our progress FAIRificating the whole data management pipeline, from processing non-FAIR data up to data usage. We looked at software tools for data integration, data storage, and data usage as well as how the FAIR Guiding Principles helped to choose appropriate tools for each task. RESULTS: We were able to advance the degree of FAIRness of our data integration as well as data storage solutions, but lack enabling more FAIR Guiding Principles regarding Data Usage. Existing evaluation methods regarding the FAIR Guiding Principles (FAIRmetrics) were not applicable to our analysis of software tools. CONCLUSION: Using the FAIR Guiding Principles, we FAIRificated relevant parts of our research data management pipeline improving findability, accessibility, interoperability and reuse of datasets and research results. We aim to implement the FAIRmetrics to our data management infrastructure and-where required-to contribute to the FAIRmetrics for research data in the biomedical informatics domain as well as for software tools to achieve a higher degree of FAIRness of our research data management pipeline.

Enabling Pedigree Visualization and Analysis in tranSMART.

This paper examines the relevance of genetic pedigree data in the context of medical research platforms. By surveying currently available tools for visualization and analysis of this data type and by considering possible use cases that could make usage of the combination of singular patient data and pedigree data, the advantages of integrating the data type into a medical research platform were shown. In a practical work step, an integration procedure of pedigree data into tranSMART was created. Furthermore, a tool to analyze and visualize pedigree data in combination with other patient data was implemented into SmartR, a dynamic analysis tool inside of tranSMART. Finally, we address limitations and future development strategies of the tool.