Résumé
Through the study of personal data protection law, the objective of this thesis is to study the consequences of the application of personal data protection law to big data in healthcare. Indeed, megadata in healthcare involves personal health data processing: it gathers data in order to reuse it, particularly for research purposes, processing is necessary. The study of efforts to structure health data assets is necessary. France centralises large amount of data from care activities funded by the Social Security: data from town care are gathered in the National Health Insurance Interregime Information System (SNIIRAM), while those relating to hospital care are available in the Medicalisation Programme Information System (PMSI). Because of their structured content, these two databases are the key components of the National Health Data System (SNDS) created in 2016. The SNDS is a megabase of diverse data, the scope of which covers, since its expansion in 2019, almost all the data produced by the actors involved in the activities covered by the Social Security, implemented by the National Health Insurance and the Health Data Hub. Although the SNDS includes a large amount of data, it is not exhaustive, particularly because of the fragmentation of health data in France. Clinical data are not available through a single structure, making it difficult to feed the SNDS. However, local initiatives, such as the creation of health data warehouses, or national initiatives, through projects covering certain aspects of the care pathway of users of the healthcare system, aim to structure the data. Once this overview of the wealth of health data in France is complete, it is necessary to analyse their conditions of access. Indeed, big data is of interest when the communication of the data is possible, in particular to reuse it for research aimed at improving the health system. However, due to the sensitivity of health data and in application of the general rules on the processing of personal data, access to big data is restricted. Reconciling these requirements with the need to reuse data entails cumbersome procedures that must be carried out both by the structures that implement processing that feeds into big data and by those who wish to reuse the data resulting from such processing. The players in the field are aware of these difficulties. To remedy them, attempts are being made to improve access to data and to support data producers and users. Although the overall application of personal data protection law is favourable to the development of big data in healthcare and its reuse, in practice it is translated into heavy and restrictive administrative procedures and these processing lacks transparency with regard to those who provide this much coveted data: the users of the healthcare system.
Source: http://www.theses.fr/2021UNIP5123
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