Abstract
Health data is the object of covetousness by many actors, of course by the healthcare industry, in particular the drug and medical device industry, by hospitals and research institutes, but also by all types of merchant companies which would like to derive substantial benefits from it. Faced with this phenomenon, the European Commission, within the framework of the replacement of the European Directive on health data of 1995, by the General Data Protection Regulation of 2016 (GDPR) has strengthened the protection of health data which is particularly sensitive data for everyone and, consequently, carrying out studies on health data. Researches that does not involve human beings, improperly called “Data studies”, are closely regulated by the GDPR and, for France, by the Data Protection Act, which has been amended accordingly. This article describes the steps to be taken for the implementation of data studies and what are the rights of participants/patients in the context of these researchs. Ethical vigilance would require that such research be reviewed by an ad hoc committee.
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