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Rare Diseases and Data Protection (Part I)
This article is concerned with the relationship between research on rare diseases and the protection of data through the EU’s General Data Protection...
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Croatia
Croatia has a number of biobanks. The paper examines Croatian legislation on the processing of health data for research purposes, specifically the...
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Anonymisation: The Trap for Biobanking (Part II)
The GDPR requires that the amount of personal data that is processed is minimised, incentivising data anonymisation. However, de-alienation between...
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Retrospective Research
The study outlines the framework for the possibility of using previously collected and stored personal health data where the data subject has given...
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Hungary
This paper shall review the possible legal bases and exemption rules for the processing of personal health data and the existing regulations for...
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Estonia
In Estonia, data sharing and the legal and social issues in biobanking are covered by law, namely the Personal Data Protection Act and the Human...
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Austria
Austrian national legislation provides for a clear legal basis for the processing of personal data for research purposes, including special...
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Bulgaria
In Bulgaria, the processing of personal data for research purposes, including genetic and biometric data, is regulated by various laws and...
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Archived Tissue
The potential use for research, under the General Data Protection Regulation (GDPR), of archived tissue specimens obtained in a diagnostic or...
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Secondary Use and Dual Use of Biomaterial Samples (Part II)
The emergence of biobanks as a vital research tool in the medical sciences has led to widespread debate in the literature about how to best handle...
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Finland
In Finland, a dedicated domestic legislation of 2013 regulates the biobanking phenomenon. The Biobank Act requires numerous formalities to set up a...
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Luxembourg
The regulatory framework for biobanking in Luxembourg is fragmented. Although some texts to regulate tissue-based biomedical research are awaiting...
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Denmark
The paper explores the regulation of biobanking in Denmark. It presents the current legal framework and analyses the specifics that differentiate it...
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Broad Consent
Informed consent plays a crucial role in biobanking, requiring adaptation to evolving contexts and advances in clinical and scientific practices....
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Lithuania
A structured legal framework and defined ethical review for biomedical research are settled in Lithuania. Data subject rights and informed consent...
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Spain
In Spain, two laws regulate biobanks: the Biomedical Research Law and the Biobanks Regulation (Royal Decree 1716/2011) These laws establish the...
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Greece
The chapter analyses the main issues with biobanks in the Greek legal framework. Greece has no tailor-made legislation for biobanks, but the Greek...
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Experts
The technology sector is going to produce new and different experts. These will include, but not limited to coding, technical development, artificial...
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Data Flows and Data Protection Law
This chapter identifies the current day members of the Commonwealth, and the data laws they have established. It will be highlighted how the title of...
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Key Definitions of Terms
This chapter examines a number of key definitions within the national arbitration laws. The chapter reinforces the overall book that, there is wide...