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

Author(s)

Benjamin R. Jefferys, Iheanyi Nwankwo, Elias Neri, David C. W. Chang, Lev Shamardin, Stefanie Hänold, Norbert Graf, Nikolaus Forgó, Peter Coveney

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.

Organisation(s)

External organisation(s)

Gottfried Wilhelm Leibniz Universität Hannover, Custodix NV, Universitätsklinikum des Saarlandes, University College London

Journal

Interface Focus

Volume

3

ISSN

2042-8898

DOI

https://doi.org/10.1098/rsfs.2012.0088

Publication date

2013

Peer reviewed

Yes

Austrian Fields of Science 2012

505010 Medical law, 505002 Data protection

Portal url

https://ucrisportal.univie.ac.at/en/publications/b23f4a5f-9f9c-4012-ad17-3116fba38c41