• Sharona Hoffman and Andy Podgurski.
• Law-Medicine Center, Case Western Reserve University School of Law, USA.
• Am J Law Med. 2013 Jan 1;39(4):497-538.

AbstractVery large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is "big data" necessarily better data? This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons for approaching such research with care and being cautious in relying on its outcomes for purposes of public policy or litigation. First, the data contained in biomedical databases is surprisingly likely to be incorrect or incomplete. Second, systematic biases, arising from both the nature of the data and the preconceptions of investigators, are serious threats to the validity of research results, especially in answering causal questions. Third, data mining of biomedical databases makes it easier for individuals with political, social, or economic agendas to generate ostensibly scientific but misleading research findings for the purpose of manipulating public opinion and swaying policymakers. In short, this paper sheds much-needed light on the problems of credulous and uninformed acceptance of research results derived from biomedical databases. An understanding of the pitfalls of big data analysis is of critical importance to anyone who will rely on or dispute its outcomes, including lawyers, policymakers, and the public at large. The Article also recommends technical, methodological, and educational interventions to combat the dangers of database errors and abuses.

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