Preserving the owner’s autonomy in networks of patient registries and biobanks

Lablans, Martin; Kadioglu, Dennis; Muscholl, Marita; Ückert, Frank

doi:10.1186/1750-1172-9-s1-p3

Cited by 3 publications

(4 citation statements)

References 7 publications

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“…Some think that decentralization plays a crucial role: “data sovereignty through decentralized data storage with access via the corresponding web services” (Doluschitz et al., 2010: 16) is key, resonating with proposals of “a method to search distributed databases, yet fully keep their owner’s data sovereignty: The decentral search exploits distributed, heterogeneous, highly sensitive datasets from equally heterogeneous systems for overarching research questions. […] a novel request mechanism that involves the owner with a high degree of control, who can ( decentrally using their own registry or biobank systems) decide if and what to answer based on a specific project proposal” (Lablans et al., 2014). Epistemic facilitators: Complementing the outlined epistemic issues, authors call for measures to mitigate informational shortcomings and to enhance transparency, for example when they demand “data sovereignty, which is basically that people need to know what data is collected about them and where it is being used.…”

Section: Resultsmentioning

confidence: 99%

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Data sovereignty: A review

et al. 2021

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New data-driven technologies yield benefits and potentials, but also confront different agents and stakeholders with challenges in retaining control over their data. Our goal in this study is to arrive at a clear picture of what is meant by data sovereignty in such problem settings. To this end, we review 341 publications and analyze the frequency of different notions such as data sovereignty, digital sovereignty, and cyber sovereignty. We go on to map agents they concern, in which context they appear, and which values they allude to. While our sample reveals a considerable degree of divergence and an occasional lack of clarity about intended meanings of data sovereignty, we propose a conceptual grid to systematize different dimensions and connotations. Each of them relates in some way to meaningful control, ownership, and other claims to data articulated by a variety of agents ranging from individuals to countries. Data sovereignty alludes to a nuanced mixture of normative concepts such as inclusive deliberation and recognition of the fundamental rights of data subjects.

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Section: Resultsmentioning

confidence: 99%

“….] a novel request mechanism that involves the owner with a high degree of control, who can (decentrally using their own registry or biobank systems) decide if and what to answer based on a specific project proposal" (Lablans et al, 2014). 3.…”

Section: Contentmentioning

confidence: 99%

Data sovereignty: A review

et al. 2021

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“…Also, the necessary interoperability between different registries is supported from the outset and allows those registries to be confederated. For this, the concept of decentralized searches was implemented, which complies with data protection requirements and preserves data sovereignty [ 9 , 10 ]. The OSSE concept focuses on the interoperability of registries and facilitates the process of establishing research networks at various levels (ie, regional and national), which is very attractive in the field of rare diseases.…”

Section: Introductionmentioning

confidence: 99%

“…This is due to low acceptance among patients and data-owning scientists regarding the controllability of data collections and their usage by third parties, particularly outside the influence of national or Europe-wide data protection rules. Instead, OSSE provides a concept for a distributed search, which makes data from rare disease registries available, while respecting data sovereignty and privacy [ 9 , 15 ]. A central search broker allows for the definition of search queries based on the existing data elements in the MDR.…”

Section: Introductionmentioning

confidence: 99%

Enabling External Inquiries to an Existing Patient Registry by Using the Open Source Registry System for Rare Diseases: Demonstration of the System Using the European Society for Immunodeficiencies Registry

Scheible¹,

Kadioglu²,

Ehl³

et al. 2020

JMIR Med Inform

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Background The German Network on Primary Immunodeficiency Diseases (PID-NET) utilizes the European Society for Immunodeficiencies (ESID) registry as a platform for collecting data. In the context of PID-NET data, we show how registries based on custom software can be made interoperable for better collaborative access to precollected data. The Open Source Registry System for Rare Diseases (Open-Source-Registersystem für Seltene Erkrankungen [OSSE], in German) provides patient organizations, physicians, scientists, and other parties with open source software for the creation of patient registries. In addition, the necessary interoperability between different registries based on the OSSE, as well as existing registries, is supported, which allows those registries to be confederated at both the national and international levels. Objective Data from the PID-NET registry should be made available in an interoperable manner without losing data sovereignty by extending the existing custom software of the registry using the OSSE registry framework. Methods This paper describes the following: (1) the installation and configuration of the OSSE bridgehead, (2) an approach using a free toolchain to set up the required interfaces to connect a registry with the OSSE bridgehead, and (3) the decentralized search, which allows the formulation of inquiries that are sent to a selected set of registries of interest. Results PID-NET uses the established and highly customized ESID registry software. By setting up a so-called OSSE bridgehead, PID-NET data are made interoperable according to a federated approach, and centrally formulated inquiries for data can be received. As the first registry to use the OSSE bridgehead, the authors introduce an approach using a free toolchain to efficiently implement and maintain the required interfaces. Finally, to test and demonstrate the system, two inquiries are realized using the graphical query builder. By establishing and interconnecting an OSSE bridgehead with the underlying ESID registry, confederated queries for data can be received and, if desired, the inquirer can be contacted to further discuss any requirements for cooperation. Conclusions The OSSE offers an infrastructure that provides the possibility of more collaborative and transparent research. The decentralized search functionality includes registries into one search application while still maintaining data sovereignty. The OSSE bridgehead enables any registry software to be integrated into the OSSE network. The proposed toolchain to set up the required interfaces consists of freely available software components that are well documented. The use of the decentralized search is uncomplicated to use and offers a well-structured, yet still improvable, graphical user interface to formulate queries.

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Register für seltene Erkrankungen

Storf

Schaaf

Kadioglu

et al. 2017

Bundesgesundheitsbl

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Meager amounts of data stored locally, a small number of experts, and a broad spectrum of technological solutions incompatible with each other characterize the landscape of registries for rare diseases in Germany. Hence, the free software Open Source Registry for Rare Diseases (OSSE) was created to unify and streamline the process of establishing specific rare disease patient registries. The data to be collected is specified based on metadata descriptions within the registry framework's so-called metadata repository (MDR), which was developed according to the ISO/IEC 11179 standard. The use of a central MDR allows for sharing the same data elements across any number of registries, thus providing a technical prerequisite for making data comparable and mergeable between registries and promoting interoperability.With OSSE, the foundation is laid to operate linked patient registries while respecting strong data protection regulations. Using the federated search feature, data for clinical studies can be identified across registries. Data integrity, however, remains intact since no actual data leaves the premises without the owner's consent. Additionally, registry solutions other than OSSE can participate via the OSSE bridgehead, which acts as a translator between OSSE registry networks and non-OSSE registries. The pseudonymization service Mainzelliste adds further data protection.Currently, more than 10 installations are under construction in clinical environments (including university hospitals in Frankfurt, Hamburg, Freiburg and Münster). The feedback given by the users will influence further development of OSSE. As an example, the installation process of the registry for undiagnosed patients at University Hospital Frankfurt is described in more detail.

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Preserving the owner’s autonomy in networks of patient registries and biobanks

Cited by 3 publications

References 7 publications

Data sovereignty: A review

Data sovereignty: A review

Enabling External Inquiries to an Existing Patient Registry by Using the Open Source Registry System for Rare Diseases: Demonstration of the System Using the European Society for Immunodeficiencies Registry

Register für seltene Erkrankungen

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