Health data protection and confidentiality in EU BTC legislation: ethical and safety standards.

Abstract

Purpose: The current paper focuses on the ethical approaches to data protection and confidentiality (DP&C) and the quality and safety (Q&S) requirements in the European Union (EU) blood, tissues and cells (BTC) legislation, namely: Directive 2002/98/EC, Directive 2004/23/EC, Directive 2005/61/EC, Directive 2005/62/EC, Directive 2006/86/EC, Commission Directive (EU) 2015/565, SWD(2019) 376 final and the external evaluation SANTE/2017/B4/010. Background: In the EU, the ethical requirements for the BTC legal framework focus also on the quality, eligibility, safety, and protection standards. In addition, the SWD(2019) 376 final on the evaluation of the EU BTC legislation released in October 2019 draws attention to the challenges of technology, consent and donation, testing procedures and management of the BTC services. Content: The paper highlights the EU BTC setting standards by examining the particular provisions for the: hemovigilance, eligibility of donors, blood and blood components (BBC), consent, decisions required at the Member States (MS) level, healthcare standards, measures for the blood establishments (BE) and tissue establishments (TE) and particular issues concerning the donation of tissues and/or cells (T&C). Conclusions: Nevertheless, the intended function of the analysis is to focus on the EU BTC legislation and to enable research responsive to the latest initiatives launched by the European Blood Alliance (EBA) and Nuffield Council on Bioethics (NCB) in the field of the definitions and ethical processes.