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

Olimid, Anca Parmena / Olimid, Daniel Alin

Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie

2022 Volume 62, Issue 4, Page(s) 1063–1067

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, ...

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.
MeSH term(s)	Computer Security ; Confidentiality ; European Union ; Humans
Language	English
Publishing date	2022-06-08
Publishing country	Romania
Document type	Journal Article
ZDB-ID	1062519-7
ISSN	2066-8279 ; 1220-0522 ; 0035-4007
ISSN (online)	2066-8279
ISSN	1220-0522 ; 0035-4007
DOI	10.47162/RJME.62.4.20
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Article ; Online: Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic.

Olimid, Anca Parmena / Olimid, Daniel Alin

Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie

2020 Volume 61, Issue 1, Page(s) 277–281

Abstract: 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 ... ...

Abstract	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. Conclusions: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.
MeSH term(s)	COVID-19 ; Clinical Trials as Topic/ethics ; Clinical Trials as Topic/legislation & jurisprudence ; Coronavirus Infections/epidemiology ; Coronavirus Infections/therapy ; Ethical Review ; Ethics Committees ; Ethics, Research ; European Union ; Health Policy ; Humans ; Informed Consent ; Pandemics ; Patient Safety ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/therapy ; Public Health ; Research Design
Keywords	covid19
Language	English
Publishing date	2020-10-19
Publishing country	Romania
Document type	Journal Article
ZDB-ID	1062519-7
ISSN	2066-8279 ; 1220-0522 ; 0035-4007
ISSN (online)	2066-8279
ISSN	1220-0522 ; 0035-4007
DOI	10.47162/RJME.61.1.34
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Article: Ethical assessment of the EU health policy under the Directive 2011∕24∕EU: approaching patients' rights and cross-border healthcare.

Olimid, Anca Parmena / Olimid, Daniel Alin

Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie

2019 Volume 60, Issue 2, Page(s) 729–735

Abstract: 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 ...

Abstract	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. An exploratory and descriptive analysis will be conducted based on these legal provisions by focusing the ethical choices, the ethical duty, the ethical reasons and the patients' rights. An introductory literature overview will be provided and an analysis of the recent data reports published by the European Commission (EC) on the application of the CBHC Directive will be detailed. Therefore, six main themes emerged: (i) the protection of the patients' rights; (ii) the examination of the ethical challenges to address the EU public health issues; (iii) the monitoring of the data reports on the operation of the CBHC Directive; (iv) the reimbursement of costs of CBHC; (v) the European reference networks (ERNs); (vi) the eHealth network and the health technology assessment (HTA). Conclusions: The paper reviews the existing legal framework aimed to support the Member States (MS) in achieving a harmonized implementation of the CBHC Directive. Hence, particular ethical issues will be developed under this regulatory framework.
MeSH term(s)	European Union/organization & administration ; Health Policy/legislation & jurisprudence ; Humans ; Patient Rights/legislation & jurisprudence
Language	English
Publishing date	2019-10-28
Publishing country	Romania
Document type	Journal Article
ZDB-ID	1062519-7
ISSN	2066-8279 ; 1220-0522 ; 0035-4007
ISSN (online)	2066-8279
ISSN	1220-0522 ; 0035-4007
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Article: Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic

Olimid, Anca Parmena / Olimid, Daniel Alin

Rom J Morphol Embryol

Abstract: 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 ... ...

Abstract	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. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #694465
Database	COVID19

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Article: Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745).

Olimid, Daniel Alin / Olimid, Anca Parmena / Ifrim Chen, Feng

Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie

2019 Volume 59, Issue 4, Page(s) 1305–1310

Abstract: 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 ...

Abstract	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. Content: From the ethical perspective, the present article investigates the new rules concerning the CIs of the MDs for human use and accessories for such devices conducted in the EU by highlighting new regulatory aspects: (1) the framework of the clinical evaluation and CI; (2) the relevant definitions; (3) the ethical principles related to CIs; (4) the informed consent; (5) the role of the national ethics committees. Conclusions: Although the new guidelines enable an extension of the definition of "medical device" and the harmonization of the rules for "the placing on market and putting into service of the medical devices", it also regulates the MDs industry to ensure clinical benefits for patients and high standards of quality and safety.
MeSH term(s)	Biomedical Research/ethics ; Biomedical Research/legislation & jurisprudence ; Equipment and Supplies/ethics ; Ethics Committees ; European Union ; Humans ; Informed Consent ; Social Control, Formal
Language	English
Publishing date	2019-02-27
Publishing country	Romania
Document type	Journal Article
ZDB-ID	1062519-7
ISSN	2066-8279 ; 1220-0522 ; 0035-4007
ISSN (online)	2066-8279
ISSN	1220-0522 ; 0035-4007
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Article: Ethical approach to the genetic, biometric and health data protection and processing in the new EU General Data Protection Regulation (2018).

Olimid, Anca Parmena / Rogozea, Liliana Marcela / Olimid, Daniel Alin

Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie

2018 Volume 59, Issue 2, Page(s) 631–636

Abstract: 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 ... ...

Abstract	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. The present article investigates the ethical and legal approaches to processing personal data in the understanding of the new regulatory guidelines regarding the data protection, here including the health status and the rights of a data subject. Conclusions: The protection of natural persons with regard to the processing of genetic, biometric and health data and the free movement of such data are reinforced in the new GDPR entered into force in May 2016 and applied from 25 May 2018. The new legal context elucidates: the special categories of personal data ("sensitive data"), the "consent" and the research exemption by explicitly recognizing the "pseudonymised" data. Although the new guidelines revisit the EU data protection reform, it also grants the EU Member States the right to maintain or introduce further limitations to the processing of such data.
MeSH term(s)	Computer Security/ethics ; European Union ; Humans
Language	English
Publishing date	2018-09-02
Publishing country	Romania
Document type	Journal Article
ZDB-ID	1062519-7
ISSN	2066-8279 ; 1220-0522 ; 0035-4007
ISSN (online)	2066-8279
ISSN	1220-0522 ; 0035-4007
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Article ; Online: Relatiile stat-biserica, fundament al diplomatiei ecleziastice

Anca Parmena Olimid

Revista de Stiinte Politice, Iss 13, Pp 61-

2013 Volume 64

Abstract: The intention of this article is to analyze the relationship Church-State not only from the point of view of the religious principles existing in Romania at the end of the 19th century and the beginning of the 20th century, but also from the point of ... ...

Abstract	The intention of this article is to analyze the relationship Church-State not only from the point of view of the religious principles existing in Romania at the end of the 19th century and the beginning of the 20th century, but also from the point of view of theinternal functioning principles of the classic legal Church and State relationships.
Keywords	the classic legal Church and State relationships ; religious principles ; internal functioning principles of the Church ; Political science (General) ; JA1-92 ; Political science ; J ; DOAJ:Political Science ; DOAJ:Law and Political Science
Language	English
Publishing date	2013-03-01T00:00:00Z
Publisher	Editura Universitaria Craiova
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Extreme Events and Social Relations Crises Research and Policy Reception

Olimid, Anca Parmena / Georgescu, Cătălina Maria Gherghe / Lucian, Cosmin

Revista de Stiinte Politice

Abstract: Iqbal Thonse Hawaldar, Cristi Spulbar, Lokesha, Ramona Birau, Cristian Rebegea) analyses data gathered from both the borrowers and the lenders installments to draw a distinctive image of the Indian financial credit market and the country's prospects for ... ...

Abstract	Iqbal Thonse Hawaldar, Cristi Spulbar, Lokesha, Ramona Birau, Cristian Rebegea) analyses data gathered from both the borrowers and the lenders installments to draw a distinctive image of the Indian financial credit market and the country's prospects for sustainable development and economic growth During the refugees, migrants and asylum-seekers international crisis, a systematic approach of the migration "cost-benefit ratio" throughout EU Member States is most welcome and invites the reader to a thorough examination of cross-border and crosssectoral EU policies Monica-Ionelia Mărgărit) discusses the inflation targeting views and monetary policy strategies of Central Banks and governments of Central and East European Countries
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #829459
Database	COVID19

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Article ; Online: The politics of self-identity in the Balkans. The role of church-state relations in forming a new com-union

Anca Parmena Olimid

Revista de Stiinte Politice, Iss 29, Pp 101-

2011 Volume 110

Abstract: This paper aims at identifying the main talking points of the Balkans collective identity assuming the hypothesis that recognizes its character of a unique phenomenon. The orientation of the paper towards a broader context of scientific analysis allows ... ...

Abstract	This paper aims at identifying the main talking points of the Balkans collective identity assuming the hypothesis that recognizes its character of a unique phenomenon. The orientation of the paper towards a broader context of scientific analysis allows the possibility of the avoidance of a political, historical, legal, and not least, religious determinism focused on the year 1989: the moment of the collapse of the “communist bloc”. The working hypothesis starts from the observation attributing to the changes of the social practices. In this situation, the paper allows a detailed exposition of the theoretical and practical elements of the evolution and role of Church-State relations in forming a collective identity in the Balkans. As to the structural dimension of the political myth-making the analysis converges towards the acceptance of the following components: social practices and relations, national self-conscience and minority condition, religious freedom and migration experience.
Keywords	identity ; Balkans ; church ; state ; com-union. ; Political science (General) ; JA1-92 ; Political science ; J ; DOAJ:Political Science ; DOAJ:Law and Political Science
Subject code	320
Language	English
Publishing date	2011-04-01T00:00:00Z
Publisher	Editura Universitaria Craiova
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Personalismul spiritual european între interpretarea ��materialistă” şi percepţia „noului creştinism

Anca Parmena Olimid

Revista de Stiinte Politice, Iss 25, Pp 94-

2010 Volume 99

Abstract: Without pretending to bring solutions, the present article tries to identify the main talking points of the religious liberty and regime of cults in the European recent history, assuming the hypothesis that recognizes its character as a unique phenomenon. ...

Abstract	Without pretending to bring solutions, the present article tries to identify the main talking points of the religious liberty and regime of cults in the European recent history, assuming the hypothesis that recognizes its character as a unique phenomenon. The present work recognizes the importance of the political theory, which becomes an indispensable instrument for the reflection and analysis of the history of religious ideas. The work does not rest on a structural analysis of politics, but is oriented towards an understanding of the dynamics of New Christianism in the context of industrial progress.
Keywords	religious liberty ; regime of cults ; Europe ; New Christianism ; industrial society ; Political science (General) ; JA1-92 ; Political science ; J ; DOAJ:Political Science ; DOAJ:Law and Political Science
Language	English
Publishing date	2010-04-01T00:00:00Z
Publisher	Editura Universitaria Craiova
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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