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Data Governance

The increasing focus on quality improvement inevitably leads to discussions regarding how to manage health care quality improvement efforts and at the same time protect patients’ privacy and other rights. Well thought through strategies for de-identifying and aggregating data is important for quality improvement and research. As EU countries have only recently begun to give more attention to linkages at a disease level between data from different data domains and/or administrations, this has led to an increased interest and focus on issues regarding stewardship of health care data. These issues need to be addressed in initiatives and projects in order for researchers to be able to access health care data.

This section brings up issues regarding health data stewardship and sustainability of health data resources. Also current development in eHealth and the stand of ethical committees in the EU are outlined below.



Data users
Data use purposes
Summaries of discharges, quality reporting, assessment of operations
Test results
Sales reports
Personal health record
Basis for reimbursement, audits, quality checking
Primary care/GPs
Assessment of quality, efficiency


Both use of data and understanding of how to exactly implement data stewardship are developing hand in hand with information technology (IT) as well as its applications. In the health care sector, the rather fast implementation of IT has brought forward an awareness of the importance of data stewardship for patient-oriented health data. The principles of data stewardship are now well established; the work of translating them into practice will continue to evolve as the urgency of data stewardship grows ever greater in the future.

Health Data Stewardship

Data stewardship is the management of an organization’s data assets (Laurent 2005) and refers to the responsibility of ensuring the appropriate use of patient-oriented health data. Safran et al (2007) define health data stewardship as the responsibilities and accountabilities associated with managing, collecting, viewing, storing, sharing, disclosing, or otherwise making use of patient-oriented health information. In health this is especially important since data is often owned by two parties. Data ownership is a sensitive issue in health care very often laws are missing regarding the exact ownership rights or responsibilities. Read more

Sustainability of health data registers

The long-term sustainability of health data registers depends on a number of factors such as funding, stewardship, data protection issues and usage. To ensure sustainability of high quality health care databases on specific diseases in the long run, the competing needs of for example registry activities vs. Quality Indicators (QI) efforts need to be thought through. Read more

Funding needs to be examined in terms of the projected life of the health data registry and/or its long-term sustainability. If de-identified data will be accessible to either internal or external groups after the health data registry closes, it is important to clarify how that activity will be managed and supported. There are many potential funding sources for registries. Funding sources are likely to want to share in planning and provide input for the many choices that will need to be made in the implementation plans. Read more

Ethical committees

The Ethics Committee, according to the EU Directive 2001/20/EC, is an independent body in a Member State of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection. Public assurance is provided by, among others, expression of opinion on the clinical trial protocol, the suitability of investigators involved, the adequacy of facilities, and methods and documents used to inform trial subjects and obtain their informed consent (EPN 2011). Read more

Fast growing use of eHealth in the EU

The EU is recognising the importance of fast growing use of IT in the health care sector and what this implies for health data. Firstly, e-health is defined as “tools and services using information and communication technologies (ICTs) that can improve prevention, diagnosis, treatment, monitoring and management”. It is recognized as benefiting the entire community by improving access to care and quality of care, as well as by making the health sector more efficient. It includes information and data sharing between patients and health service providers, hospitals, health professionals and health information networks; electronic health records; telemedicine services; portable patient-monitoring devices, operating room scheduling software, robotized surgery and research on the virtual physiological human. Read more

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