Background To foster responsible data sharing in health research, ethical governance
complementary to the EU General Data Protection Regulation is necessary. A governance …

Background Large-scale linkage of international clinical datasets could lead to unique
insights into disease aetiology and facilitate treatment evaluation and drug development …

To address the ethical challenges in big data health research we propose the concept of
systemic oversight. This approach is based on six defining features (adaptivity, flexibility …

Introduction International sharing of health data opens the door to the study of the so-called
'Big Data', which holds great promise for improving patient-centred care. Failure of recent …

Background It has been argued that ethics review committees—eg, Research Ethics
Committees, Institutional Review Boards, etc.—have weaknesses in reviewing big data and …

Abstract Background The rise of Big Data-driven health research challenges the assumed
contribution of medical research to the public good, raising questions about whether the …

Data sharing is a precondition of precision medicine. Numerous organizations have
produced abundant guidance on data sharing. Despite such efforts, data are not being …

Examples of biomedical big data are routinely-collected health data. These may include
information collected in electronic health records (EHRS), disease registries, or health …

Background We aimed to examine the ethical concerns Singaporeans have about sharing
health-data for precision medicine (PM) and identify suggestions for governance strategies …

Before the EU General Data Protection Regulation entered into force in May 2018, we
witnessed an intense struggle of actors associated with data-dependent fields of science, in …