Data Governance for Real-World Evidence: Cross-country differences and recommendations for a governance framework
Data Governance for Real-World Evidence:
Cross-country differences and
recommendations for a governance framework
Cole, A.1, Garrison, L.2, Mestre-Ferrandiz, J.1 & Towse A.1
Contact: firstname.lastname@example.org 1Office of Health Economics, 2Universtiy of Washington
Real-world data (RWD) is information that can be used for
health care decision-making which is collected outside of an
experimental clinical trial setting. RWD is becoming
increasingly important to:
• Reflect outcomes in routine clinical practice
• Meet the needs of regulators and payers, who are being
challenged to conduct earlier assessments under greater
uncertainty, and monitoring outcomes throughout a
RWD becomes real-world evidence (RWE) – what is really
of value to stakeholders – after a series of activities which
facilitate the transformation of raw data into analysis and
results. Robust and proportionate data governance, applied at
each step, is essential in realising the value of RWD and its
This research was funded and initiated by Eli Lilly and Company
• To analyse the core governance arrangements for how RWD is
accessed or generated, and used credibly to provide evidence,
in eight countries.
• To propose an aspirational governance framework.
• Investigate the governance arrangements in place in the UK,
France, Italy, Sweden, Germany, Netherlands, Australia, and
• Use a structured pro-forma to assess core legislation for the
collection and use of (both routinely-collected and de novo)
data, data linkage opportunities, the data access environment,
data use, and imminent changes to this landscape.
• Identify strengths and weaknesses in the current international
approaches to data governance.
In order to utilise and derive value from RWD, appropriate and
facilitative information governance is essential, thus transforming
RWD into RWE.
• Difficulties arise because RWD is
being used for purposes beyond
those for which it was originally
collected: to directly manage
• Legal frameworks are playing
catch-up to accommodate these
new secondary uses of data,
which also benefit patients and
society, but in a different way.
• By describing the process by which RWD (the raw data) is
transformed into RWE (the insight), and assessing the rules
and roles for information governance along this process in
eight countries, we set out a framework for good governance
which supports a favourable environment for RWE
development and use.
• Countries have different approaches for achieving the balance
between protecting privacy and supporting research that is in
the public’s interest. In most cases the legal framework is not
completely prescriptive, making a clear governance framework
• Appropriate and facilitative governance arrangements for RWE
are imperative to facilitate evidence collection to meet the
demands of regulators and HTA bodies, and to make the most
of health care information and the role it can play in improving
Recommendations for an ideal governance framework include:
• Data protection legislation. There must be clear protection
requirements that recognise the legitimacy of health care data
utilisation beyond the direct care of patients.
• Patient consent has a central role; where data collection is
on a routine basis across a large patient cohort, an opt-out
system of consent may be appropriate.
• There should be transparent mechanisms for data linkage
which employ pseudonymisation tools to protect anonymity but
maintain data integrity. For datasets to be compatible there
needs to be a clear set of nationally agreed standards to
optimise interoperability of health record systems.
UK US France Italy
Sweden Germany Netherlands Australia
We developed and outlined 29 elements of an ideal governance
framework, and considered all countries against each criteria
Aligned with recommendation
Aspect addressed but room for
Barrier or very problematic
Insufficient information to make
Current governance arrangements compare variably against our
recommendations. For example, in Italy data collection is strong
but access is poor. National data linkage networks, such as that
established in Australia, offer huge potential. However,
transparency is essential: UK and Netherlands provide examples
of public trust breaking down, thus impeding RWD programmes.
Sweden and the U.S. perform well across our proposed
framework; Germany and France are more restrictive.
• Data access arrangements should be based on careful
consideration of the motivation for and outputs of the
research facilitated, rather than on the basis of the
organisation’s status. Authorisation should be granted by
approval panels which assess risks and benefits,
implementing data use agreements as necessary.
• The core objective is to balance public and privacy interests:
to advance our understanding of medical treatments through
evaluation and research, on the one hand, and protect
individuals’ privacy, on the other.