Will Data Privacy Impact Health Research?

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.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    European Community. Directive 95/46/EC of the European Parliament and the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Brussels, Belgium: European Community Commission; 1995.

    Google Scholar 

  2. 2.

    Lowrance WW. The promise of human genetic databases. High ethical as well as scientific standards are needed. Br Med J. 2001;322(7293):1009–1010.

    CAS  Article  Google Scholar 

  3. 3.

    Knudsen LE, Renneberg J. Regulatory aspects of the application of pharmacogenetics in drug discovery and development in Europe. Good Clin Pract. 2000; 7(6):11–13.

    Google Scholar 

  4. 4.

    Theilade MD, Ehlert Knudsen L, Renneberg J. Regulatory requirements for inclusion of pharmacogenetic testing in applications for clinical trials in Europe. Regulatory Aff J. 2001; 12(2):92–99.

    Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Jacques Mascaro PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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

Download citation

Key Words

  • Data privacy
  • Directive 95/46/EC
  • European Community