Ethical foresight may reduce the probability of regulatory and social ‘whiplash’ by informing public and policy debates. To contribute to this process for platforms enabling medical research based on ‘real-world evidence’ (RWE), a systematic and comprehensive review of academic literature on the ethical, social, and legal implications (ELSI) of medical data repositories was conducted to identify the issues of emerging importance for this novel form of data curation and analysis.  This deliverable is a first step to defining the ELSI requirements for a RWE approach to AD research. Academic literature discussing ethical and social aspects of an RWE approach and medical data sharing was systematically surveyed to produce a narrative review of relevant concepts and issues. The review aimed to address one primary question:

What ethical and social issues arise in a real-world evidence approach to medical research and healthcare decision-making?

In order to understand how these issues have already been identified and discussed in the context of RWE, a systematic survey of academic literature was conducted between November 2016 and March 2017. A total of 2484 non-unique sources were identified for review across the databases, with 81 sources fully reviewed. The results of the review are presented as a narrative overview, which highlights and comments upon key themes and topics in the literature. Through content analysis, seven major themes emerged from the literature: (1) informed consent; (2) autonomy and participation; (3) transparency; (4) ownership; (5) data provenance; (6) privacy; and (7) group harms and discrimination.