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Research derived from the application of information and communication technologies in medicine operates in a context involving the globalization of collecting, sharing, storage, transfer and re-use of personal health data. Health data computerization within Clinical Information Systems (as Electronic Healthcare Records) should allow the re-use of health data for clinical research and public health purposes. One of the objects allowing the integration of healthcare and research information systems is the health data-warehouse (DWH). However, ethical-legal frameworks in force are not adapted to these DWHs because they were not conceived for re-using data in a different context than the one of their acquisition. For that matter, access modalities to data-warehouses must ensure the respect of patients' rights: information to the patient, as well as confidentiality and security. Through a bibliography research, some Ethical, legal and Social Issues (ELSI) have been identified: Patients' rights Modalities of implementation of the DWs; Solidarity and common good; Transparency and Trust. Comparative analysis between the Directive 95/46/CE and the "Proposal for regulation on protection of individuals with regard to the processing of personal data" shows that this regulation pretends allowing the re-use of key-coded data when aimed at a scientific purpose. However, since this new regulation does not align with the ethical and legal requirements at an operational level, a Code of practice on secondary use of Medical Data in scientific Research Projects has been developed at the European Level. This Code provides guidance for Innovative Medicine Initiative (IMI) and will help to propose practical solutions to overcome the issue of the re-use of data for research purposes.

Ethical, Legal and Social Issues related to the health data-warehouses: re-using health data in the research and public health research