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abstract:paper1 [2010/10/06 11:49]
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abstract:paper1 [2010/11/02 11:44] (current)
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-**Bert de Brock, Tommi Tervonen, Hans Hillege and Pieter de Graeff**+**Sietse Overbeek, Virginia Dignum and Yao-Hua Tan**
-// Current Status and Future Perspectives of Drug Information Systems// +// {{:extendedabstract_1.pdf|Value-Sensitive Design for Cross-Enterprise Regulation}}//
-The information lifecycle of a drug starts already during the drug discovery phase and continues far into the future in prescription- and adverse-effect databases. In this paper, we describe the past literature and existing technology of Drug Information Systems (DIS). We develop a mapping of DIS to the phased drug lifecycle taking into account the system information contents. The mapping shows that currently there is a lack of DIS providing efficacy- and safety data in a suitable format. This lack severely hinders the possibility of physicians, researchers, as well as regulatory authorities and the pharmaceutical industry, to make quantitative analyses of efficacy and safety over a wide range of drugs.+The pressure to increase organizational transparency, the rise of proper IT support for regulative activities and the increasing cost of regulation are a few notable drivers that stress the significance of cross-enterprise regulation. Compliance to regulations fuels the added-value that business processes represent and prevents judiciary pursuits. Norm enforcement mechanisms are used to determine whether organizations have complied with the regulations or norms, which can be divided into mechanisms that are oriented towards direct control and mechanisms that are oriented towards self regulation. When designing a system to support agents in norm fulfillment and enforcement, the relation between norm enforcement mechanisms and the abstract values that are behind them should be explicitly incorporated in the development of the system. In this paper, a first step in the development of such a value-sensitive system is taken by formalizing the values of direct control and self regulation. The paper also outlines the following steps that are necessary to complete the development of the proposed value-sensitive system process towards a full system implementation.
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