Enabling the Flexible Integration of Trusted Third Party Tools in OSSE Registries - A Technical Case Report.

INTRODUCTION: Medical registries and their electronic data capture systems, such as the Open-Source Registry System for Rare Diseases (OSSE), require integration of trusted third party (TTP) services to meet data protection requirements. STATE OF THE ART: While OSSE is currently coupled to the Mainzelliste, deployment in research infrastructures such as the Network University Medicine (NUM) demands more flexible support for heterogeneous TTP tools. CONCEPT: We developed OSSE TTP, a configurable adapter mediating communication between the OSSE EDC and TTP services. The modular design maintains compatibility with existing OSSE-based registries and workflows while enabling integration into established infrastructures such as NUM NUKLEUS. IMPLEMENTATION: The OSSE TTP prototype supports selection of the Mainzelliste or E-PIX/gPAS for identity management and pseudonymization, with optional connection to gICS for consent management. It provides the necessary endpoints and user interfaces for seamless integration into existing workflows and authorization concepts. A demonstrator was successfully developed and will be validated prior to gradual deployment within the NUM4Rare infrastructure. LESSONS LEARNED: OSSE TTP extends the applicability of OSSE through flexible, service-agnostic TTP integration, building on existing processes and interfaces to ensure data protection-compliant data exchange. The modular design can accommodate future integration of additional TTP services. Overall, OSSE TTP provides a flexible and data protection-compliant foundation for connecting various TTP services to OSSE, representing a key step toward the integration of OSSE-based registries into research infrastructures.