Abstract
European Community Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and the free movement of such data establishes a framework for the harmonization of regulations on the privacy of personal data. This directive has changed the regulatory framework in the European Union and has the potential to impact the use of human data generated during product development or postlicensing. This article reviews aspects and provisions of the directive and the ways in which it may affect clinical trial and data management activities. It evaluates existing safeguards and the ways in which they could minimize the negative effects of the directive without minimizing its noble and valid objective. The impact of regulations in other countries, specifically with regard to issues such as anonymization (defined by the American Society of Human Genetics as irreversibly stripping all identifiers from biological materials that were originally collected and identified and making them impossible to link to their sources) for privacy and use of data in relation to new technologies such as genetics and genomics are also covered.
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Knudsen, L.E., Theilade, M.D., Gordon, A. et al. Will Data Privacy Impact Health Research?. Ther Innov Regul Sci 36, 465–480 (2002). https://doi.org/10.1177/009286150203600227
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DOI: https://doi.org/10.1177/009286150203600227