Encoding of Numerical Data for Privacy-Preserving Record Linkage.

BACKGROUND: Privacy-preserving record linkage (PPRL) is the process of detecting dataset entries that refer to the same individual within two independent datasets, without disclosing any personal information. While applied in different fields, it particularly attained importance in the medical sector. One popular PPRL method are Bloom filters. However, Bloom filters were originally used for encoding strings only. OBJECTIVES: This paper evaluates an encoding method specifically designed for numerical data and adjusts it for encoding geocoordinates in Bloom filters. METHODS: The proposed numerical encoding of geocoordinates is compared to the string-based method by using synthetic data. RESULTS: The proposed method for encoding geocoordinates in Bloom filters attains a higher recall and precision than the conventional string encoding. CONCLUSION: Numerical encoding has the potential of increasing the record linkage quality of Bloom filters, as well as their privacy level.

IT Infrastructure for Merging Data from Different Clinical Trials and Across Independent Research Networks.

Opsoclonus Myoclonus Syndrome (OMS) is a rare disease in children which is often associated with neuroblastoma and, therefore, requires treatment by pediatric neurologists and oncologists. The ongoing OMS trial investigates questions related to OMS and potentially underlying neuroblastomas. To support this trial with an adequate IT infrastructure, linkage of neuroblastoma research databases with the OMS electronic data capture (EDC) system was required. Therefore, an EDC system for the OMS trial was developed and integrated into the research infrastructure of the European Network for Cancer Research in Children and Adolescents (ENCCA) project. Application of ENNCA's pseudonymization concept enabled linkage of the OMS trial with neuroblastoma trials from two different scientific societies, while being compliant with current data protection regulations. Linkage of the neurological and the oncological domain could successfully be demonstrated and a promising concept for secondary use of the data of both domains has been developed, proofing the broad potential of the concepts for cross-domain research as promoted in the ENCCA project.

Piloting the European Unified Patient Identity Management (EUPID) Concept to Facilitate Secondary Use of Neuroblastoma Data from Clinical Trials and Biobanking.

Data from two contexts, i.e. the European Unresectable Neuroblastoma (EUNB) clinical trial and results from comparative genomic hybridisation (CGH) analyses from corresponding tumour samples shall be provided to existing repositories for secondary use. Utilizing the European Unified Patient IDentity Management (EUPID) as developed in the course of the ENCCA project, the following processes were applied to the data: standardization (providing interoperability), pseudonymization (generating distinct but linkable pseudonyms for both contexts), and linking both data sources. The applied procedures resulted in a joined dataset that did not contain any identifiers that would allow to backtrack the records to either data sources. This provided a high degree of privacy to the involved patients as required by data protection regulations, without preventing proper analysis.

Interoperability Architecture for a Paediatric Oncology European Reference Network.

With the Directive 2011/24/EU on patients' rights in cross-border healthcare and the related delegated decisions, the European Commission defined a legal framework on how healthcare shall be organised by European Union (EU) member states (MS) where patients can move beyond the borders of their home country. Among other aspects, Article 12 of the directive is concerned with supporting MS with the development of so called European Reference Networks (ERN), dedicated to the treatment of "patients with a medical condition requiring a particular concentration of expertise in medical domains where expertise is rare". In the "European Expert Paediatric Oncology Reference Network for Diagnostics and Treatment" (ExPO-r-Net) project, the establishment of such an ERN in the domain of Paediatric Oncology is currently piloted. The present paper describes the high level use cases, the main requirements and a corresponding interoperability architecture capable to serve as the necessary IT platform to facilitate cross-border health data exchange.

Electronic Patient Reported Outcomes in Paediatric Oncology - Applying Mobile and Near Field Communication Technology.

BACKGROUND: Electronic Patient Reported Outcomes (ePRO) gathered using telemonitoring solutions might be a valuable source of information in rare cancer research. OBJECTIVES: The objective of this paper was to develop a concept and implement a prototype for introducing ePRO into the existing neuroblastoma research network by applying Near Field Communication and mobile technology. METHODS: For physicians, an application was developed for registering patients within the research network and providing patients with an ID card and a PIN for authentication when transmitting telemonitoring data to the Electronic Data Capture system OpenClinica. For patients, a previously developed telemonitoring system was extended by a Simple Object Access Protocol (SOAP) interface for transmitting nine different health parameters and toxicities. RESULTS: The concept was fully implemented on the front-end side. The developed application for physicians was prototypically implemented and the mobile application of the telemonitoring system was successfully connected to OpenClinica. Future work will focus on the implementation of the back-end features.

Standardized data sharing in a paediatric oncology research network--a proof-of-concept study.

Data that has been collected in the course of clinical trials are potentially valuable for additional scientific research questions in so called secondary use scenarios. This is of particular importance in rare disease areas like paediatric oncology. If data from several research projects need to be connected, so called Core Datasets can be used to define which information needs to be extracted from every involved source system. In this work, the utility of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) as a format for Core Datasets was evaluated and a web tool was developed which received Source ODM XML files and--via Extensible Stylesheet Language Transformation (XSLT)--generated standardized Core Dataset ODM XML files. Using this tool, data from different source systems were extracted and pooled for joined analysis in a proof-of-concept study, facilitating both, basic syntactic and semantic interoperability.

Architecture for an advanced biomedical collaboration domain for the European paediatric cancer research community (ABCD-4-E).

Today, progress in biomedical research often depends on large, interdisciplinary research projects and tailored information and communication technology (ICT) support. In the context of the European Network for Cancer Research in Children and Adolescents (ENCCA) project the exchange of data between data source (Source Domain) and data consumer (Consumer Domain) systems in a distributed computing environment needs to be facilitated. This work presents the requirements and the corresponding solution architecture of the Advanced Biomedical Collaboration Domain for Europe (ABCD-4-E). The proposed concept utilises public as well as private cloud systems, the Integrating the Healthcare Enterprise (IHE) framework and web-based applications to provide the core capabilities in accordance with privacy and security needs. The utility of crucial parts of the concept was evaluated by prototypic implementation. A discussion of the design indicates that the requirements of ENCCA are fully met. A whole system demonstration is currently being prepared to verify that ABCD-4-E has the potential to evolve into a domain-bridging collaboration platform in the future.

Patient identity management for secondary use of biomedical research data in a distributed computing environment.

Dealing with data from different source domains is of increasing importance in today's large scale biomedical research endeavours. Within the European Network for Cancer research in Children and Adolescents (ENCCA) a solution to share such data for secondary use will be established. In this paper the solution arising from the aims of the ENCCA project and regulatory requirements concerning data protection and privacy is presented. Since the details of secondary biomedical dataset utilisation are often not known in advance, data protection regulations are met with an identity management concept that facilitates context-specific pseudonymisation and a way of data aggregation using a hidden reference table later on. Phonetic hashing is proposed to prevent duplicated patient registration and re-identification of patients is possible via a trusted third party only. Finally, the solution architecture allows for implementation in a distributed computing environment, including cloud-based elements.