gms | German Medical Science

Background: The ever-increasing amount of clinical and other health-related data can be a valuable resource for research and quality improvement activities and is thus seen as a key driver for learning health systems. For effective secondary use researchers need access to the data. In hospital settings, clinical data warehouses (CDW) build the central part of the data infrastructure that consolidates and integrates data from various sources. CDW hold responsibility of the data stewardship, thus playing a crucial role in the data access process. To date, little is known about how access governance is structured and handled in practice in CDW. The aim of this study was to assess the current state of governance of data access in CDW internationally.

Methods: We performed a systematic review of 1) published scientific literature on CDW and 2) publicly available CDW policies. A protocol has been prepared using the PRISMA-P 2015 Checklist and published online [1]. Search terms were developed through an iterative process and the PRESS checklist was used to ensure inclusion of essential elements in the search strategy. PubMed, Web of Science, ACM Portal, CINAHL, IEEExplore and Google Scholar have been searched and an exhaustive Google search for CDW and CDW policies has been performed. The retrieved literature was screened for eligibility using RAYYAN. A qualitative thematic analysis was applied to all included policies and literature.

Results: The systematic search for scientific literature yielded 4,249 hits of which 23 publications were included in the final analysis. No CDW policies could be retrieved that met our inclusion criteria. In general, available information on governance of data access in CDW is scarce, both in the scientific literature and via Google searches. The retrieved literature mainly focusses on technical aspects of CDW governance, e.g. regarding implementation and maintenance of a CDW in a hospital, or interoperability with other IT solutions. Governance of data use and access was not the main objective of any included publication. In fact, all included publications only marginally address governance of data access. There is high terminological variance across concepts, roles and documents. Twelve distinct use and access criteria were reported. The criteria reported were seldom specified in a manner that would allow clear and transparent decision-making.

Conclusion: From an ethical perspective, CDW should provide designated governance structures and policies (e.g. access policy, data sharing policy) to increase transparency about data access. In such policies, CDW should disclose by whom and under which conditions data can be accessed. The limited availability of information in the literature, and even more the lack of information on CDW websites (including the lack of available policies) may threaten public trust and, in turn, willingness to consent in data usage for secondary research purposes. Thus, it may weaken the potential of a learning health system. The results of this review may contribute to the development of practice-oriented minimal standards for the governance of data access which could also contribute to more harmonisation, efficiency, and effectiveness.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.