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Technological progresses and the changed way to collect, access and use data are at the bottom of the European Commission proposal for a “General Data Protection Regulation” (25 January 2012). Implications of safeguarding privacy and harmonization of existing rules are extremely important also for national Health Systems. Mobility of patients and health professionals as well as cross-border healthcare connected with the increasing use of Information and Communication Technologies in Healthcare Services are modifying traditional medical approaches and applications. New tools, as Electronic Health Records, provide significant benefits as empowering health consumers and minimizing health costs. Anyway, EHRs have limits: for example, they should cause risks for individuals, professionals and institutions in terms of personal injuries and liabilities. In this scenario, it's evident that technical aspects (as health standards and interoperability) are as important as legal and regulatory privacy issues. Presently, mandatory acts on the protection of individuals with regard to the processing of health e-Data still missing at all levels. Italy is adopting binding and non-binding legal documents to tackle the problem. Are they enough?
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