State Responsibility and Accountability in Managing Big Data in Biobank Research: Tensions and Challenges in the Right of Access to Data
Within the European context the Data Protection Directive (Directive 95/46/EC) maintains an important role in current legal debates on the rights and obligations different stakeholders have in the processing of personal data. Biobanking and data sharing infrastructures pose new ethical and legal dilemmas in the interpretations we uphold with regard to the processing of personal data. This chapter examines the challenges associated with the data subject's right of access to data in Finnish biobanking. The Data Protection Directive provides provisions for individuals to confirm "as to whether or not data relating to him are being processed" Finland's recent Biobank Act (688/2012) has raised concerns since it also requires biobanks to provide, upon request, information regarding data which may have clinical (actionable) relevance for the individual's personal health. There is, however, no governance mechanism in place through which common standards and practices could be implemented. As a result the extension of the right to access data and mandating biobanks to relate significance of results to personal health has become a major concern for biobankers in Finland. The management of data, research results and incidental findings in biobanks is becoming, however, an increasingly significant challenge for all biobanks and the countries which are in the process of drafting policy and regulatory frameworks for the management and governance of big data, public health genomics and personalised medicine. The Finnish case highlights the challenges that many states are increasingly facing across Europe and elsewhere in terms of how to govern and coordinate the management of biomedical big data.