NUM-RDP

Due to the close integration with the MII, the NUM-RDP project has been designed and expanded to complement the NUM-DIZ project. The DIZ infrastructure set up at each university location serves to orchestrate and operate central key components. In the future, this will be enriched by further components provided within the MII funding line (e.g. the German portal for medical research data (FDPG). Thus, the future NUM-RDP/MII services will include the following:

1. A central platform for secure access to data, enabling data from multiple DICs to be integrated and made available as a central integrated dataset for individual data use projects that fulfil the legal requirements for using a central data pool (e.g. patient consent or state data protection law).
2. A centralised portal for conducting federated queries in the university hospitals and requesting access to available data and biosamples. The portal supports a structured application process and a publicly accessible website that informs the public about the data utilisation projects carried out.
3. A central dashboard that provides visualisations of aggregated data and statistics as well as model-based predictions using processed data streams from NUM partner sites in near real-time.

To enable the operation of these services, NUM-RDP also offers various support services and structures. NUM-RDP, together with NUM-DIZ, NUM-RACOON and other NUM infrastructure projects, will develop into a national resource where high quality health data, patient partnerships and research expertise provide fast, trustworthy answers that improve health outcomes.

There are a number of challenges for the operation and further development of the RDP infrastructure, which can be divided into two areas:

Regulatory-organisational challenges

• Implementation of a consent-based approach (MII Broad Consent) to create a standardised legal basis for joint data usage projects
• Heterogeneous legal frameworks for the use of patient data
• Compliance with all ethical and legal requirements, in particular the General Data Protection Regulation
• Recruitment of staff and development and maintenance of competences for long-term operation
• Convergence with existing developments in MII

Technical challenges

• Harmonisation and validation due to the heterogeneous data structure / data availability at the locations
• Consolidation of medical data from the same person across multiple locations
• Structured provision of medical data for researchers
• Seamless integration of developments into the future national infrastructure, consisting of MII and NUM components

NUM-RDP extends the existing federated national infrastructure for the integration and exchange of data at university hospitals. The NUM-RDP is provided by the MII and the NUM-DIZ for the re-utilisation of health data for research purposes in German university hospitals by the operation of central key components.

The chain of operated central components includes

1. a transfer hub for structured communication with the DICs
2. a federated Trusted Third Party (fTTP), which links and pseudonymises data sets from the DIZ and external sources while maintaining patient privacy
3. a platform that guarantees centralised, secure access to the data compiled from several surveys for secondary use
4. centralised terminology services
5. a near real-time, privacy-by-design dashboarding infrastructure with fully interoperable, federated data aggregation endpoints connected to a centralised, publicly accessible dashboard front-end

Infrastructure components of the MII such as the FDPG, which implements transparency mechanisms and supports the coordination of data requests from researchers, are also seamlessly integrated. In addition, NUM-RDP provides other NUM projects with its consulting expertise on data protection and cyber security issues.

Together with the NUM-DIZ project, which provides the decentralised components, and in close collaboration with the MII, the RDP infrastructure provides a wide range of users, including researchers, the interested public and policy makers, with both centralised access to high-quality, pseudonymised clinical data and integrated and actionable aggregated information. With its open and interoperable interfaces, NUM-RDP forms a central pillar of the flexible national data exchange infrastructure of the future, on which other NUM infrastructures and scientific projects can rely.