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Real-World Evidence: European Union Definition of Health Data
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The European Parliament and the Council of the European Union (EU legislators) on 14 March 2024 agreed on the text of a regulation creating European Health Data Space (EHDS). The agreement includes the definition of health data as follows:
Health data is referred to as including health records, clinical trials, pathogens, health claims and reimbursements, genetic data, public health registry information, wellness data and information on healthcare resources, expenditure and financing.
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