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Interface Focus. 2013 Apr 6;3(2):20120088. doi: 10.1098/rsfs.2012.0088.

Navigating legal constraints in clinical data warehousing: a case study in personalized medicine.

Author information

1
Centre for Computational Science, Department of Chemistry , University College London , London WC1H 0AJ , UK.
2
Institut für Rechtsinformatik (IRI) , Leibniz Universität Hannover , Königsworther Platz 1, 30167 Hannover , Germany.
3
Custodix, Kortrijkseteenweg, 9830 Sint-Martens-Latem , Belgium.
4
Saarland University Hospital Faculty of Medicine , Campus Homburg Building no. 9, 66421 Homburg , Germany.

Abstract

Personalized medicine relies in part upon comprehensive data on patient treatment and outcomes, both for analysis leading to improved models that provide the basis for enhanced treatment, and for direct use in clinical decision-making. A data warehouse is an information technology for combining and standardizing multiple databases. Data warehousing of clinical data is constrained by many legal and ethical considerations, owing to the sensitive nature of the data being stored. We describe an unconstrained clinical data warehousing architecture, some of the legal constraints that have led us to reconsider this architecture, and the legal and technical solutions to these constraints developed for the clinical data warehouse in the personalized medicine project p-medicine. We also propose some changes to the legal constraints that will further enable clinical research.

KEYWORDS:

clinical data warehouse; legal and ethical constraints; personalized medicine

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