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

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 2005/6...

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Autores principales: Olimid, Anca Parmena, Olimid, Daniel-Alin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Academy of Medical Sciences, Romanian Academy Publishing House, Bucharest 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9289719/
https://www.ncbi.nlm.nih.gov/pubmed/35673827
http://dx.doi.org/10.47162/RJME.62.4.20
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author Olimid, Anca Parmena
Olimid, Daniel-Alin
author_facet Olimid, Anca Parmena
Olimid, Daniel-Alin
author_sort Olimid, Anca Parmena
collection PubMed
description 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.
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spelling pubmed-92897192022-07-21 Health data protection and confidentiality in EU BTC legislation: ethical and safety standards Olimid, Anca Parmena Olimid, Daniel-Alin Rom J Morphol Embryol Biomedical Research Ethics 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. Academy of Medical Sciences, Romanian Academy Publishing House, Bucharest 2021 2022-04-13 /pmc/articles/PMC9289719/ /pubmed/35673827 http://dx.doi.org/10.47162/RJME.62.4.20 Text en Copyright © 2020, Academy of Medical Sciences, Romanian Academy Publishing House, Bucharest https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open-access article distributed under the terms of a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International Public License, which permits unrestricted use, adaptation, distribution and reproduction in any medium, non-commercially, provided the new creations are licensed under identical terms as the original work and the original work is properly cited.
spellingShingle Biomedical Research Ethics
Olimid, Anca Parmena
Olimid, Daniel-Alin
Health data protection and confidentiality in EU BTC legislation: ethical and safety standards
title Health data protection and confidentiality in EU BTC legislation: ethical and safety standards
title_full Health data protection and confidentiality in EU BTC legislation: ethical and safety standards
title_fullStr Health data protection and confidentiality in EU BTC legislation: ethical and safety standards
title_full_unstemmed Health data protection and confidentiality in EU BTC legislation: ethical and safety standards
title_short Health data protection and confidentiality in EU BTC legislation: ethical and safety standards
title_sort health data protection and confidentiality in eu btc legislation: ethical and safety standards
topic Biomedical Research Ethics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9289719/
https://www.ncbi.nlm.nih.gov/pubmed/35673827
http://dx.doi.org/10.47162/RJME.62.4.20
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