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The Influence of General Data Protection Regulation on Patient Engagement

Author

Listed:
  • Andreea ŞERBAN

    (Alexandru Ioan Cuza University of Iaşi, Faculty of Law)

  • Stefan Razvan TATARU

    (Alexandru Ioan Cuza University of Iaşi, Faculty of Law)

Abstract

The new European General Data Protection Regulation – also known as GDPR – has raised the awareness among the private business entities regarding the protection of data subjects and the usage of personal data in their trade operations. In the present study, we aim at identifying and assessing the impact the new Regulation mainly on the life science sector, with a particular focus on clinical trials. Besides the subjects of the clinical trials, patients as the data subjects and the protection of their rights, when conducting scientific research in the medical-pharmaceutical field, we seek to define concepts such as sensitive data and data concerning health, data processing in scientific research and roles of all parties involved through the definitions of data subject, controller, processor or recipient given in the GDPR. The scope of the present research is represented by the analysis of the impact of the GDPR provisions on the derogations relating to processing for scientific research purpose on the rights of the clinical trial subjects.

Suggested Citation

  • Andreea ŞERBAN & Stefan Razvan TATARU, 2018. "The Influence of General Data Protection Regulation on Patient Engagement," Logos Universalitate Mentalitate Educatie Noutate - Sectiunea Drept/ Logos Universality Mentality Education Novelty - Section: Law, Editura Lumen, Department of Economics, vol. 6(1), pages 56-72, October.
    • Handle: RePEc:lum:rev13d:v:vi:y:2018:i:1:p:56-72
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    References listed on IDEAS

    as
    1. Peabody, John W., 1995. "An organizational analysis of the World Health Organization: Narrowing the gap between promise and performance," Social Science & Medicine, Elsevier, vol. 40(6), pages 731-742, March.
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    More about this item

    Keywords

    clinical trials; general data protection regulation; clinical subject; patient engagement; GDPR.;
    All these keywords.

    JEL classification:

    • A23 - General Economics and Teaching - - Economic Education and Teaching of Economics - - - Graduate

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