Author: K. Donsa, K. Kreiner, D. Hayn, A. Rzepka, S. Ovejero, M. Topolnik, A. Ziegl, B. Pfeifer, S. Neururer, S. Kaltenbrunner, E. Klager, K. Zatloukal, B. Zatloukal, T. Schabetsberger, M. L. Garcia, N. Tanjga, G. Schreier

DOI: 10.3233/SHTI240351

Publication Date: August 2024

Abstract:
Access to healthcare data for secondary use in clinical research is often restricted due to privacy concerns or business interests, hindering comprehensiveanalysis across patient pathways. The Smart FOX project seeks to address this challenge by developing concepts, methods, and tools to facilitate citizen/patient-driven donations of health data for clinical research. Leveraging the groundwork, laid by the national Electronic Health Record implementation in Austria (called ELGA), Smart FOX aims to harness structured datasets from ELGA for research purposes through an opt-in approach. With funding secured from the Austrian Research Promotion Agency, the project embarks on innovative solutions encompassing governance frameworks, community engagement, and technical infrastructure. The Smart FOX consortium, comprising key stakeholders across various healthcare-associated domains, will evaluate these efforts through demonstrators focusing on clinical registries, patient-generated data, and recruitment services. The project targets to accompany the development of future data donation infrastructure while ultimately advancing clinical research efficiency and bolstering Austria’s preparedness for the European Health Data Space.This paper presents the first systematic evaluation of the technical concept and proposal for the federated system architecture of the Austrian Health Data Donation Space, which is the socio-technical goal of Smart FOX.

Author: K. Donsa, P. Mangesius, A. Lauschensky, M. Baumgartner, N. Tanjga, S. Beyer, G, Schreier, K. Kreiner

DOI: 10.3233/SHTI250187

Publication Date: April 2025

Abstract:
Efficient secondary use of real-world data (RWD) is a cornerstone for advancing data-driven medical research and personalised healthcare. However, significant challenges persist, including data fragmentation in silos, the lack of record linkage, and legal constraints that often hinder data utilisation. Especially Electronic Health Records (EHRs) represent a valuable data source, yet their potential remains largely untapped due to these barriers. Especially modern data space solutions promise to address these challenges, focusing on standardisation and harmonisation efforts, data governance aspects, as well as federated data-sharing approaches. A significant push in this area represents the European Health Data Space (EHDS) Act, focusing on an opt-out based approach for secondary use of health data. An additional consent-based approach (opt-in) represents data donation, which empowers individuals to contribute their data to research while maintaining trust and privacy under the current legal situation. The flagship project Smart FOX lays the foundations for making citizen-based data donations of EHR-standardised information usable in clinical research in Austria. As part of the architecture of the Austrian Health Data Donation Space (AHDDS), data donation boxes - Federated Open data eXchange Boxes (FOX BOXes) - present the fundamental decentralised building blocks for sharing EHR-standardised data. This paper outlines the architecture, functionality, and governance of FOX BOXes, highlighting its role in overcoming key barriers to health data sharing and its potential to accelerate data-driven research.

Author: S. Ovejero, C. Bezzi, S. huber, J. Harrer, A. Lauschensky, K. Donsa

DOI: 10.3233/SHTI250195

Publication Date: April 2025

Abstract:
The secondary use of healthcare data can play a crucial role in enhancing health care systems, patient care, and clinical research; however, it is challenged by privacy, governance and regulatory challenges. The aim of the Smart FOX project is to address these challenges to facilitate citizen-driven donation of ELGA (Austria Electronic Health Records) - standardized. The project consortium comprises stakeholders across several healthcare-related areas developing concepts and architectures for patient/citizen driven data-donation. This paper specifically introduces two distinct services for recruiting patients and citizens to enable secondary data use within the project. Service A, a researcher-focused service integrated in the hospital information system, within the Smart FOX project focuses on two primary use cases: enabling the study of new trial cohorts for data consumers (e.g., CROs), and contacting data donors (e.g., citizens) for trial recruitment. Service B, a web-based patient/citizen focused service, addresses three key use cases: identifying recruitment potential, facilitating contact with the recruitment pool, and presenting data donation opportunities via digital advertising and on its internet platform. By leveraging innovative digital platforms and federated data approaches, the Smart FOX project aims to overcome barriers in secondary data use, ultimately driving more efficient, inclusive, and secure clinical research that benefits both healthcare systems and patients/citizens.