Data governance

The potential for the use of real-world data (RWD) to generate real-world evidence (RWE) that can inform clinical decision-making and health policy is increasingly recognized, albeit with hesitancy in some circles. If used appropriately, the rapidly expanding wealth of health data could improve healthcare research, delivery of care, and patient outcomes.


The development of data governance structures and HTA processes for the use of RWE have been greatly supported by patient advocacy groups, which have facilitated awareness of and education around how these kinds of RWD can help to improve patient outcomes (for example, through public–private partnership initiatives). A common European Health Data Space (EHDS) could support access to different types of health data, with the aim of supporting healthcare delivery, research and policy making. Specifically, this data system is intended to support Member States with data governance and data exchange, data quality, and infrastructure and interoperability. The provisions on data governance – which will largely influence data sharing – are in a more advanced stage of preparation, with the European Parliament aiming to adopt its position on the proposals during the summer of 2021.

In parallel, several Member States are registering complaints about what they regard as excessive privacy safeguards, such as the requirement for repeat users to continually assess the risk of re-identification. For access to health data to inspire trust and be efficient, it is vital that the data governance provisions do not restrict options for the EHDS and provide adapted options depending on the type of RWD needing to be shared.


Policy papers

Please see the following relevant documents

A Europe-wide data ecosystem for personalised medicine - A proposal for a Lighthouse Initiative

Big data report - EHFG

European data-driven economy: A Lighthouse Initiative for Personal Medicine

Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare

Clouds across the new dawn for clinical, diagnostic and biological data: accelerating the development, delivery and uptake of personalized medicine

Empowering quality data - the Gordian knot of bringing real innovation into healthcare system

Big Data Roadmap for Personalised Medicine (PPT)



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Creating a Data Ecosystem for Personalised Medicine in Europe – it would accelerate the development of more effective treatments and potentially help with the management of healthcare resources and it would also act as a foundation for private sector investment and jobs in R&D in Europe.

Global developments and coherent strategy in approaches to Big Data in healthcare – this will a direct effect on the attractiveness of a given health system for the placement of clinical trials.

The European Union should see Big Data as a strategic investment that could drive industrial competitiveness.

Development and dissemination of tools and processes able to analyse and interpret the data, creating new knowledge that can benefit patients accurately and directly.

Empowerment of the patients and ensuring access to their own data.

Doctors’ access to the best information and diagnostic techniques available – analytics tools for “Big Data” can help healthcare professionals improve diagnoses and reshape the way medicine is practiced. 

Data governance


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