title: Navigating legal constraints in clinical data warehousing: a case study in personalized medicine.
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.
authors.affiliation: Centre for Computational Science, Department of Chemistry , University College London , London WC1H 0AJ , UK.
authors.forename: Benjamin R
authors.initials: BR
authors.lastname: Jefferys
authors.affiliation: Institut für Rechtsinformatik (IRI) , Leibniz Universität Hannover , Königsworther Platz 1, 30167 Hannover , Germany.
authors.forename: Iheanyi
authors.initials: I
authors.lastname: Nwankwo
authors.affiliation: Custodix, Kortrijkseteenweg, 9830 Sint-Martens-Latem , Belgium.
authors.forename: Elias
authors.initials: E
authors.lastname: Neri
authors.affiliation: Centre for Computational Science, Department of Chemistry , University College London , London WC1H 0AJ , UK.
authors.forename: David C W
authors.initials: DC
authors.lastname: Chang
authors.affiliation: Centre for Computational Science, Department of Chemistry , University College London , London WC1H 0AJ , UK.
authors.forename: Lev
authors.initials: L
authors.lastname: Shamardin
authors.affiliation: Institut für Rechtsinformatik (IRI) , Leibniz Universität Hannover , Königsworther Platz 1, 30167 Hannover , Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Hänold
authors.affiliation: Saarland University Hospital Faculty of Medicine , Campus Homburg Building no. 9, 66421 Homburg , Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Graf
authors.affiliation: Institut für Rechtsinformatik (IRI) , Leibniz Universität Hannover , Königsworther Platz 1, 30167 Hannover , Germany.
authors.forename: Nikolaus
authors.initials: N
authors.lastname: Forgó
authors.affiliation: Centre for Computational Science, Department of Chemistry , University College London , London WC1H 0AJ , UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Coveney
keywords: clinical data warehouse; legal and ethical constraints; personalized medicine