RAND reports on Real World Health Data Policy in Europe

Health and Healthcare: Assessing the Real World Data Policy Landscape in Europe | RAND

Real-world data (RWD) is an umbrella term for different types of 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. There are already examples of ways in which research has contributed to the provision, construction and capture of RWD to improve health outcomes. However, 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 in order 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.

Based on a literature review, case studies, a small set of interviews of experts from public and private organisations and a scenario based workshop, the study outlined possible strategies to illustrate how RWD standards development 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.

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Table 15 Improving access to and use of RWD: from barriers to enablers

Barriers	Strategies to improve access and use
Content and quality issues –
Terminology issues	Standardisation of codes
Incomplete data	Longitudinal data collection
Data quality issues	Processes for data quality assurance
Methodological barriers
Limited analytics capabilities	National eHealth strategies
Lack of analytical standards	Transnational and multisectoral coalition of experts
Linkage challenges  European	projects and best practices
Fragmentation	Interoperable systems
Governance structures
Lack of clear pathway	Buying the data
Access granted to academics only	Hiring/partnering with academics
Lack of data controller engagement	Incentives for clinicians
Privacy practices –
Ethical concerns among professionals	Trusted third party, depersonalisation tools
Ethical concerns among the public	Communication campaigns
Consent management	Liberal national strategies and innovative consent management tools