A model for realizing interoperable EHR systems in Italy

BACKGROUND: The Italian Constitution delivers autonomy to each Region about healthcare, thus fostering the proliferation of different and heterogeneous healthcare information systems. In this scenario, realizing interoperable regional EHR systems, and at the same time, satisfying all the complex requirements and constraints indicated by a recent Italian law, is very challenging. OBJECTIVES: This paper describes the process undertaken in Italy to implement a nationwide interoperable EHR system by supporting the development of homogeneous regional solutions in order to improve healthcare efficiency and reduce costs . METHODS: An architectural model has been designed i) in order to respect a shared ISO/HL7 EHR-S FM-based functional model defined at the national level, ii) by specifying a topology both at the regional and national level able to ensure technical interoperability and security, and iii) by identifying solutions for an unambiguous exchange of clinical documents and data through HL7 CDA Rel. 2 and LOINC standards. RESULTS: A federated architectural model which aims at enabling both technical and semantic interoperability among various regional healthcare information systems has been devised. The model has been approved by the Agency for Digital Italy, the Ministry of Health, governmental institutions, Regions and Autonomous Provinces. CONCLUSIONS: This work represents an important first step into the process of digitalizing the Italian health record system. The proposed model is turning out to be successful for both Regions that have already started an e-health process and Regions that are still at the starting line. Further technical details are still to be defined along with the implementation process.