Journal
EUROPEAN HEART JOURNAL
Volume 43, Issue 37, Pages 3578-3588Publisher
OXFORD UNIV PRESS
DOI: 10.1093/eurheartj/ehac426
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Funding
- Innovative Medicines Initiative 2 Joint Undertaking [116074]
- European Union's Horizon 2020 research and innovation programme
- European Federation of Pharmaceutical Industries and Associations
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Big data is crucial in global clinical science for improving patients' lives. However, challenges such as verification, validation, and data privacy need to be addressed. The proposed CODE-EHR Minimum Standards Framework aims to enhance research design, transparency, and utilization of healthcare data.
Big data is central to new developments in global clinical science aiming to improve the lives of patients. Technological advances have led to the routine use of structured electronic healthcare records with the potential to address key gaps in clinical evidence. The covid-19 pandemic has demonstrated the potential of big data and related analytics, but also important pitfalls. Verification, validation, and data privacy, as well as the social mandate to undertake research are key challenges. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including patient representatives, clinicians, scientists, regulators, journal editors and industry. We propose the CODE-EHR Minimum Standards Framework as a means to improve the design of studies, enhance transparency and develop a roadmap towards more robust and effective utilisation of healthcare data for research purposes.
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