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Machine Learning in Medicine: journal article open-access

Opening the New Data Protection Black Box

Agata Ferretti, Manuel Schneider, Alessandro Blasimme

European Data Protection Law Review, Volume 4 (2018), Issue 3, Page 320 - 332

Artificial intelligence (AI) systems, especially those employing machine learning methods, are often considered black boxes, that is, systems whose inner workings and decisional logics remain fundamentally opaque to human understanding. In this article, we set out to clarify what the new General Data Protection Regulation (GDPR) says on profiling and automated decision-making employing opaque systems. More specifically, we focus on the application of such systems in the domain of healthcare. We conducted a conceptual analysis of the notion of opacity (black box) using concrete examples of existing or envisaged medical applications. Our analysis distinguishes among three forms of opacity: (i) lack of disclosure, (ii) epistemic opacity, and (iii) explanatory opacity. For each type of opacity, we discuss where it originates from, and how it can be dealt with according to the GDPR in the context of healthcare. This analysis can offer insights regarding the contested issue of the explainability of AI systems in medicine, and its potential effects on the patient-doctor relationship. Keywords: Artificial Intelligence, Machine Learning, Black Box, Medicine, GDPR, Transparency


Machine Learning for Diagnosis and Treatment: journal article

Gymnastics for the GDPR

Robin Pierce

European Data Protection Law Review, Volume 4 (2018), Issue 3, Page 333 - 343

Machine Learning (ML), a form of artificial intelligence (AI) that produces iterative refinement of outputs without human intervention, is gaining traction in healthcare as a promising way of streamlining diagnosis and treatment and is even being explored as a more efficient alternative to clinical trials. ML is increasingly being identified as an essential tool in the arsenal of Big Data for medicine. ML can process and analyse the data resulting in outputs that can inform treatment and diagnosis. Consequently, ML is likely to occupy a central role in precision medicine, an approach that tailors treatment based on characteristics of individual patients instead of traditional ‘average’ or one-size-fits-all medicine, potentially optimising outcomes as well as resource allocation. ML falls into a category of data-reliant technologies that have the potential to enhance healthcare in significant ways. However, as such, concerns about data protection and the GDPR may arise as ML assumes a growing role in healthcare, prompting questions about the extent to which the GDPR and related legislation will be able to provide adequate data protection for data subjects. Focusing on issues of transparency, fairness, storage limitation, purpose limitation and data minimisation as well as specific provisions supporting these principles, this article examines the interaction between ML and data protection law. Keywords: Machine Learning, GDPR, Data Protection, Artificial Intelligence in Medicine, Health Data, Automated Processing, Data Minimisation

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