Handling Complexity in Decentralized Research Networks: The Data Sharing Framework Allowlist Management Application.

INTRODUCTION: With the establishment of the Data Sharing Framework (DSF) as a distributed business process engine in German research networks, it is becoming increasingly important to coordinate authentication, authorization, and role information between peer-to-peer network components. This information is provided in the form of an allowlist. This paper presents a concept and implementation of an Allowlist Management Application. STATE OF THE ART: In research networks using the DSF, allowlists were initially generated manually. CONCEPT: The Allowlist Management Application provides comprehensive tool support for the participating organizations and the administrators of the Allowlist Management Application. It automates the process of creating and distributing allowlists and additionally reduces errors associated with manual entries. In addition, security is improved through extensive validation of entries and enforcing review of requested changes by implementing a four-eyes principle. IMPLEMENTATION: Our implementation serves as a preliminary development for the complete automation of onboarding and allowlist management processes using established frontend and backend frameworks. The application has been deployed in the Medical Informatics Initiative and the Network University Medicine with over 40 participating organizations. LESSONS LEARNED: We learned the need for user guidance, unstructured communication in a structured tool, generalizability, and checks to ensure that the tool's outputs have actually been applied.

Interoperability Is a Process - The Data Sharing Framework.

Common syntax and data semantics are core components of healthcare interoperability standards. However, interoperable data exchange processes are also needed to enable the integration of existing systems between organizations. While solutions for healthcare delivery processes are available and have been widely adopted, support for processes targeting bio-medical research is limited. Our Data Sharing Framework creates a platform to implement research processes like cohort size estimation, reviews and approvals of research proposals, consent checks, record linkage, pseudonymization and data sharing across organizations. The described framework implements a distributed business process engine for executing BPMN 2.0 processes with synchronization and data exchange using FHIR R4 resources. Our reference implementation has been rolled out to 38 organizations across three research consortia in Germany and is available as open source under the Apache 2.0 license.

No Transfer Without Validation: A Data Sharing Framework Use Case.

Availability and accessibility are important preconditions for using real-world patient data across organizations. To facilitate and enable the analysis of data collected at a large number of independent healthcare providers, syntactic- and semantic uniformity need to be achieved and verified. With this paper, we present a data transfer process implemented using the Data Sharing Framework to ensure only valid and pseudonymized data is transferred to a central research repository and feedback on success or failure is provided. Our implementation is used within the CODEX project of the German Network University Medicine to validate COVID-19 datasets at patient enrolling organizations and securely transfer them as FHIR resources to a central repository.

Monitoring Distributed Business Processes in Biomedical Research.

In biomedical research, business processes, such as data-sharing or feasibility queries, span across several healthcare organizations. Due to the growing number of data-sharing projects and connected organizations, the management of distributed processes gets more complex over time. This leads to an increased need for administrating, orchestrating, and monitoring all distributed processes of a single organization. A proof of concept for a decentralized and use case agnostic monitoring dashboard was developed for the Data Sharing Framework, which most German university hospitals have deployed. The implemented dashboard can handle current, changing, and upcoming processes using only information for cross-organizational communication. This differentiates our approach from other existing use case specific content visualizations. The presented dashboard is a promising solution to provide administrators with an overview of the status of their distributed process instances. Therefore, this concept will be further developed in upcoming releases.