Advancing clinical research by semantically interconnecting aggregated medical data information in a secure context
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Electronic Health Records (EHRs) contain an increasing wealth of medical information. When combined with molecular level data, they enhance the understanding of the underlying biological mechanisms of diseases, enabling the identification of key prognostic biomarkers to disease and treatment outcomes. However, the European healthcare information space is fragmented due to the lack of legal and technical standards, cost effective platforms, and sustainable business models. There is a clear need for a framework facilitating the efficient and homogenized access to anonymized distributed EHRs, merged from multiple data sources into a single data analysis space. In this paper we present the outcomes of Linked2Safety, a project that proposes a solution to these problems by providing a semantically interconnected approach to sharing aggregate data in the form of data cubes. This approach eliminates the risks associated with sharing pseudoanonymized (and therefore still personal) data while enabling the multi-source, multi-type analysis of health data through a single web based secure access platform. The Linked2Safety system is evaluated by external to the project Medical science analysts, Analytic methodology engineers and Data providers with respect to five specific dimensions of the system (analysis space, linked data space, usability of the system, legal and ethical issues, and value of the system) in this paper. For all five dimensions that were examined, the participants’ perceptions were overwhelmingly positive.
KeywordsSemantic Interoperability Linked2Safety Electronic health records Personal data protection Anonymity Adverse Event prediction Genetic analysis
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
The research leading to these results was conducted as part of the project A next-generation secure linked data medical information space for semantically-interconnecting electronic health records and clinical trials systems advancing patients safety in clinical research (Linked2Safety) that received fund- ing from the European 1Union’s Seventh Framework Pro- gramme (FP7/2007–2013) under Grant Agreement No 288328.
Ethical approval was acquired by each data provider for each subject and this is available in the deliverables of Linked2Safety. A thorough review in line with the contractual agreement between the partners of the project and the European Commission was conducted, and where relevant ethical board approvals were collected for data that was included in the deployment of the platform.
As part of the evaluation of ethical approvals for each data provider, it has been verified that informed consent was obtained from all individual participants included in the study.
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