Publications by authors named "Anca Parmena Olimid"
Objectives: The role of the current research is to set up a conceptual and analytical framework of the security, democracy and human rights linkage in contemporary society mainly based on the indexing, monitoring and research of online content for the period 1945-2019.
Methods And Methodology: Due to the focused timeline outlining the scientific research for the period 1945-2019, the paper favors both quantitative and qualitative approaches that follow a systemic framework of several thematic clusters which act as supporting pillars of analytical research by using Google Ngrams: (a) norms and constitutional values and principles; (b) civil and legal liberties; (c) human and individual approaches; (d) institutional governance and organizational establishment; (e) freedoms, civil and political rights.
Results And Discussions: The research results explore the variations in the frequency of appearances of the selected concepts in the specialized literature indexed by the Google platform indicating essential aspects of the conceptual and theoretical evolutions in strict dependence to the significant resolutions of the Security Council of the United Nations adopted in the same period and focusing on three central concepts: security, democracy and human rights.
Health data protection and confidentiality in EU BTC legislation: ethical and safety standards.
Rom J Morphol Embryol
June 2022
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.
Purpose: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field.
Background: The Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data.
Content: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework.
Purpose: The purpose of the present article is to discuss the ethical challenges of the European Union (EU) health legislation framing the patients' rights and the cross-border healthcare (CBHC).
Background: The paper reviews the EU main legislation in the field, namely the Directive 2011∕24∕EU (CBHC Directive) of the European Parliament and of the Council of 9 March 2011, on the application of patients' rights in CBHC.
Content: The aim of the study is to analyze the patients' rights and the CBHC, enhancing the healthcare support and coordination under this regulatory framework.
Purpose: The main purpose of the present paper is to analyze the rules for processing of special categories of personal data (genetic data, including biological samples, biometric and health data) in the light of the new General Data Protection Regulation (GDPR), thus contributing to overview the health status and the biomedical state of the data subject.
Background: Over the last two decades, debating the European Union's (EU) major legislation with regard to personal data and patients' rights became relevant for the scientific research. The paper assesses the basic legal provisions with regard to the genetic, biometric and data concerning health considered as "sensitive data", while safeguarding the ethical standards of the scientific research.
Purpose: The paper focuses on the ethical appraisal of the clinical investigations (CIs) and the informed consent within the new European Union (EU) legislation on medical devices (MDs). The Regulation (EU) 2017∕745 of the European Parliament and of the Council was adopted on 5 April 2017 and entered into force on 25 May 2017, repealing the Council Directives concerning Medical Devices 93∕42∕EEC and the Active Implantable Medical Devices 90∕385∕EEC.
Background: For the past thirty years, the EU legislation on MDs has been updated by several directives: Council Directive 90∕385∕EEC on Active Medical Devices (1990); Council Directive 93∕42∕EEC on Medical Devices (1993) and Council Directive 98∕79∕EC on In vitro Medical Devices (1998) aiming to frame the MDs market development.