Zobrazeno 1 - 10
of 28
pro vyhledávání: '"Teodora Lalova"'
Publikováno v:
npj Digital Medicine, Vol 7, Iss 1, Pp 1-5 (2024)
Abstract EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the mann
Externí odkaz:
https://doaj.org/article/d5356ebe75a2414da58ff115cf3b471f
Autor:
Teodora Lalova-Spinks, Robbe Saesen, Mitchell Silva, Jan Geissler, Iryna Shakhnenko, Jennifer Catherine Camaradou, Isabelle Huys
Publikováno v:
Frontiers in Pharmacology, Vol 14 (2024)
Background: In the European Union, the General Data Protection Regulation (GDPR) plays a central role in the complex health research legal framework. It aims to protect the fundamental right to the protection of individuals’ personal data, while al
Externí odkaz:
https://doaj.org/article/1d39cd6ab333416bbd63106501d4a242
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
BackgroundThe legal framework for clinical research in the EU is complex and the lack of harmonization of the relevant legal and ethical rules remains one of the main challenges for stakeholders in the field. The recently adopted Data Governance Act
Externí odkaz:
https://doaj.org/article/5b72c2d0d711492b85e0be83c81b212a
Autor:
Teodora Lalova-Spinks, Evelien De Sutter, Peggy Valcke, Els Kindt, Stephane Lejeune, Anastassia Negrouk, Griet Verhenneman, Jean-Jacques Derèze, Ruth Storme, Pascal Borry, Janos Meszaros, Isabelle Huys
Publikováno v:
Frontiers in Medicine, Vol 9 (2022)
BackgroundThe COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenge
Externí odkaz:
https://doaj.org/article/cbd5655f44584711aaf64c50d9fecb1f
Autor:
Steven Simoens, Khadidja Abdallah, Liese Barbier, Teresa Barcina Lacosta, Alessandra Blonda, Elif Car, Zilke Claessens, Thomas Desmet, Evelien De Sutter, Laurenz Govaerts, Rosanne Janssens, Teodora Lalova, Evelien Moorkens, Robbe Saesen, Elise Schoefs, Yannick Vandenplas, Eline Van Overbeeke, Ciska Verbaanderd, Isabelle Huys
Publikováno v:
Frontiers in Pharmacology, Vol 13 (2022)
Background: Countries are struggling to provide affordable access to medicines while supporting the market entry of innovative, expensive products. This Perspective aims to discuss challenges and avenues for balancing health care system objectives of
Externí odkaz:
https://doaj.org/article/bbc0089204d243a890fa9366197ff0a6
Autor:
Evelien De Sutter, Teodora Lalova-Spinks, Pascal Borry, Peggy Valcke, Els Kindt, Anastassia Negrouk, Griet Verhenneman, Jean-Jacques Derèze, Ruth Storme, Isabelle Huys
Publikováno v:
Frontiers in Medicine, Vol 9 (2022)
BackgroundOwing to the infectious nature of COVID-19, alternative solutions, such as electronic informed consent (eIC), needed to be implemented to inform research participants about study-related information and to obtain their consent. This study a
Externí odkaz:
https://doaj.org/article/3923f9e14fb54d178b974dcd1fbe80d5
Autor:
Teodora Lalova, Cristina Padeanu, Anastassia Negrouk, Denis Lacombe, Jan Geissler, Ingrid Klingmann, Isabelle Huys
Publikováno v:
Frontiers in Medicine, Vol 7 (2020)
Objectives: To analyze the current situation of cross-border access to clinical trials in the EU with an overview of stakeholders' real-life experience, and to identify the needs, challenges, and potential for facilitation of cross-border access.Meth
Externí odkaz:
https://doaj.org/article/2dd5faad906f4fb0bc16d47c92df78f8
Autor:
Daniela Bresic, Teodora Lalova-Spinks
In its European strategy for data, the European Commission strives for the empowerment of individuals in exercising their data subject’s rights. Particularly the right to data portability is said to offer great potential for increasing the availabi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::4cc46f179e9eb644bb5a30a85c94a39f
https://hdl.handle.net/11585/890035
https://hdl.handle.net/11585/890035
The broadening of the right to data portability for IoT products: Who does the Act actually empower?
Autor:
Daniela Bresic, Teodora Lalova-Spinks
In light of the European Commission goal to create a data-agile economy, the empowerment of data subjects is currently at the centre of new EU policy initiatives. The notion of empowerment is often equated with the strengthening of control over one
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=od______4094::e4adef98457345448ac4922a5992f206
https://hdl.handle.net/11585/910897
https://hdl.handle.net/11585/910897
Publikováno v:
European journal of health law. 27(5)
The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e53af8f35c7bdba20c4d50a5aeba4006
https://pubmed.ncbi.nlm.nih.gov/33652387
https://pubmed.ncbi.nlm.nih.gov/33652387