1. Introduction



The transformation of Digital Health enables to collect real-world data (RWD)1 and real-world evidence (RWE) using digital technologies and advanced analytics. In this context and according to the joint HMA/EMA Big Data Task Force  [2] RWD/RWE can be considered a source for Big Data. The task force defines and describes Big Data from a regulatory perspective as follows:

'Big data' is a widely-used term without a commonly-accepted definition. The HMA/EMA Big Data Task Force defined big data as ‘extremely large datasets’ which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends, and associations. In general, big data sets require advanced or specialised methods to provide an answer within reliable ‘constraints’.

A single dataset may not strictly meet the definition of big data but, when pooled or linked with other datasets, they become sufficiently large or complex to analyse to assume the characteristics of big data. Sources include real-world data (such as electronic health records, insurance claims data and data from patient registries), genomicsclinical trials, spontaneous adverse drug reaction reports, social media and wearable devices.

Medicines regulators will increasingly use insights derived from big data to assess the benefit-risk of medicines across their lifecycle.

Note 1:  European Commission Communication on enabling the digital transformation of health and care in the Digital Single Market (Reference 1) says:  Real world data is big data, referring specifically to any type of data not collected in a randomised clinical trial. This data can complement randomised clinical trial data to fill the knowledge gap between clinical trials and clinical practice, provide new insights into disease patterns and help improve the safety and effectiveness of health interventions.

Note 2: The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines regulatory network to make best use of big data in support of innovation and public health in the European Union (EU). http://www.hma.eu/506.html?&L=0