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Development of a Trusted Third Party at a Large University Hospital: Design and Implementation Study.

Eric Wündisch1, Peter Hufnagl2, Peter Brunecker3

  • 1Core Unit THS, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany.

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|April 18, 2024
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Summary

This study introduces a user-friendly Trusted Third Party (TTP) system for secure medical research data management. The TTP streamlines pseudonymization and consent processes, reducing operational effort and enhancing data security for research projects.

Keywords:
EHRapplicationarchitectureconsentdata managementdata privacyelectronic health recordhealth platformhealth recordidentifying dataimplementationinfrastructuremodularpseudonymisationpseudonymizationscalabilitysecuritysoftwaretrusted third partyuser interface

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Area of Science:

  • Medical Informatics
  • Data Security
  • Health Research Management

Background:

  • Pseudonymization is crucial for secure management of patient and study participant identities in medical research.
  • Trusted Third Parties (TTPs) often handle pseudonymization, but their implementation can increase workflow complexity.
  • Adequate tool support is necessary for managing complex pseudonymization and data sharing processes.

Purpose of the Study:

  • To address the lack of published information on TTP architectures and tools in large university hospitals.
  • To describe the software architecture and toolset developed for a TTP at Charité - Universitätsmedizin Berlin.
  • To provide a model for other institutions seeking to establish efficient and effective TTPs.

Main Methods:

  • Designed a modular TTP infrastructure with low maintenance requirements, utilizing MOSAIC tools for basic functions.
  • Developed an integration layer with a unified REST API to enable complex workflows spanning patient registration, pseudonym generation, and consent collection.
  • Implemented a unified graphical user interface (GUI) and utilized Keycloak for unified role and rights management.

Main Results:

  • The TTP has supported over 10 research projects since December 2019, managing over 3000 identities and generating over 30,000 pseudonyms.
  • More than 150 individuals regularly use the platform, with over 1500 consent forms submitted.
  • The integration layer and unified GUI significantly reduced TTP operational effort, enabling independent use by research project personnel.

Conclusions:

  • The developed TTP architecture provides a user-friendly and compliant environment for supporting medical research projects.
  • The insights gained from this TTP implementation can guide other institutions in establishing similar structures.
  • Efficient and effective TTPs are vital for modern, secure medical research data management.