There is general optimism and enthusiasm that the introduction of Big Data and related technologies
will substantially change and improve delivery of medical care and healthcare decision making. In
the project proposed here we will explore how the use of routinely collected data (RCD) can be of
real benefit for healthcare decision-making. To achieve this objective, we will explore the technical,
legal and ethical problems related to collecting and aggregating data, data quality, and assess how
and to what extent these data can be turned into evidence. Subsequently, we will examine the
prospects of relying on RCD in the market authorisation and surveillance of pharmaceuticals and
medical devices. Afterwards, the use of algorithm-based decision-making and their impact on ethical
and legal issues related to transparency, accountability and liability will be assessed. Based on these
findings, we will investigate how the evidence resulting from RCD can be further integrated into
transparent and comprehensible clinical decision-making by healthcare professionals and patients.