Assessing the Real-World Data Policy Landscape for Health and Healthcare in Europe


Optical fibres around globe, circuit board background, global digital technology concept

Real-world data (RWD) is an umbrella term for different types of healthcare data that are not collected in conventional randomised controlled trials. RWD in the healthcare sector comes from various sources and includes patient data, data from clinicians, hospital data, data from payers and social data.

Research has contributed to the provision, construction and capture of RWD to improve health outcomes, but to maximise the potential of these new pools of data in the healthcare sector, stakeholders need to identify pathways and processes which will allow them to efficiently access and use RWD to achieve better research outcomes and improved healthcare delivery. Current efforts to improve access to RWD and facilitate its use take place in a context of resource scarcity.


The objectives of the work were the following:

  • Construct an evidence base on the establishment and evolution of standards governing the collection and use of RWD and identify the different ways in which standards have been applied.
  • Understand the factors that have enabled or limited access to and use of RWD.
  • Learn lessons from the use of RWD in different contexts
  • Identify opportunities for increasing access to RWD and contributing constructively to standard setting in Europe.


RAND Europe, supported by IBM, worked through a multi-method approach to assess different RWD pathways that the health and healthcare sector has explored and the options going forward. Based on a literature review, case studies, a small set of interviews of experts from public and private organisations, and a scenario-based workshop, researchers outlined possible strategies to illustrate how the development of standards could facilitate RWD-based research.


By investigating the current forms and uses of RWD in Europe, this study has highlighted their significant potential for assessing the (short- or long-term) impact of different drugs or medical treatments and for informing and improving healthcare service delivery. Although the potential of RWD use seems quite clear, this research reveals barriers that restrict further development towards its full exploitation:

  • the absence of common standards for defining the content and quality of RWD
  • methodological barriers that may limit the potential benefits of RWD analysis
  • governance issues underlying the absence of standards for collaboration between stakeholders
  • privacy concerns and binding data protection legislation which can be seen to restrict access and use of data.

RAND Europe Project Team

Céline Miani
Enora Robin
Veronika Horvath
Catriona Manville
Jonathan Cave
Joanna Chataway