ABSTRACT

Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare is aimed at ensuring patient mobility, establishing some rules for facilitating access to safe and high-quality healthcare and promoting cooperation on healthcare between Member States, whilst fully respecting their responsibilities in the organisation and delivery of such healthcare. In this report the impact of the aforementioned Directive in the Italian National Legal System is analyzed.

Summary: 1. Description of the National Legal System. 2. Description of the legal instrument of transposition. 2.1. Procedure for transposition. 2.2. Features of legislative decree n. 38/2014. 3. National Contact Points. 4. Progress in the regulation of transparent complaints procedures and of systems of professional liability. 5. Progress in the regulation of the impact in patient’s rights to health data protection. 6. Progress in the regulation and implementation of e-health systems. 7. Development of provisions regarding the reimbursement of the cost of treatments and the need of prior authorization. 8. Impact in the regulation concerning European reference networks between healthcare providers and centres of expertise. 9. Progress in the instruments for the cooperation in the development of diagnosis and treatment capacity in relation to rare diseases. 10. Other impact of the Directive. Special reference to Rare Diseases.