Will Data Privacy Impact Health Research?
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Drug l n f o m r i o n Journal, Vol. 36, pp. 4 6 4 8 0 , 2002 Printed in the USA. All rights reserved.
Copyright 0 2002 Drug Information Association Inc.
WILL DATA PRIVACY IMPACT HEALTH RESEARCH? LISBETHEHLERTKNUDSEN,PHD Associate Professor, Institute of Public Health, University of Copenhagen, Denmark
ME-ITE DUETHEILADE, PHD, MSO Danish Medicines Agency, Copenhagen, Denmark
ARNOLDGORDON,PHD Independent Consultant, Greenwich, Connecticut
JACQUES MASCARO, PHD Johnson & Johnson. United Kingdom, Hjgh Wycombe, United Kingdom
RUDOLFBRUPPACHER, MD School of Pharmacy, University of Basel, Basel, Switzerland
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. Key Words: Data privacy; Directive 95146EC; European Community
INTRODUCTION
into force on October 25, 1998. The directive establishes a framework for the harmonization of regulations on the privacy of personal 95/46/EC on the protection of individuals data. It has changed the regulatory with regard to the processing of personal data work in the European Union and has the and the free movement of such data (1) was potential to impact the use of human data adopted on October 24, 1995 and entered generated during product development and bstlicensing. Since this directive became effective, other countries have also published Reprint address: Jacques Mascaro, PhD, Johnson & Johndata privacy standards and regulations. son, Pharmaceutical Research and Development. Haw This article reviews aspects and provisheSamdeflm, figh w y C o m~~~b ~ , ~ p 1 4m, ions of the directive and the ways in which it United Kingdom. E-mail: jmcaro.prdgb.jnj.com. 465
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L Ehlen Knudsen, M.D. Theilade, A. Gordon, J. Mascaro, and R. Bruppacher
may affect clinical trial and data management activities, and 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 ot
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