1. EHR Systems Use and Quality in EHR Systems Use and Quality in Italy EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

2. Country context Basic facts about: -the country a regionally-based health service paid by taxes provides universal coverage -the health care system national level ensures general objectives and fundamental principles; regional governments ensure the actual care delivery through Community Care Trusts (Local Health Units) and public and private accredited hospitals EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

3. Country context Basic facts about: -General IT status within the health sector the Ministry of Health, the Ministry of Innovation and the Regions have agreed to operate jointly to carrying out the ehealth national strategies and particularly for EHR diffusion, through a State-Regions coordinating board. Formal certification process is not currently in place in Italy. EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

4. EHR systems: market Market for the different segments EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade Medical Systems in primary careabout 20 Ml Clinical Information Systemsless than 10 Ml Hospital information systemsabout 150 Ml Department of Health Systemsless than 15 Ml Systems integration Hospital Territoryabout 200 Ml Country Information System NSISabout 25 Ml Regional systemsabout 50 Ml

5. EHR systems: market Market shares EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade revenue (Ml euro)EHR SuppliersProducts Over 50 DEDALUSProducts supported by services ENGINEERINGServices (products are instrumental) about 30 NOEMALIFEProducts supported by services EXPRIVIAmost services SanterServices about 10 LUTECHServices 5 to 10 GPImost services ADS-DPmost products SIGMAmost services Under 4 IASIProducts and services 10 companies.Products and services

6. EHR systems: market Number of suppliers (approx.) EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade GPHospital Homecare /Nursing vendors11435 systems13435 int’l1

7. EHR systems: market Evolution of the market EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade million euro (source The Healthcare Information Technology Market, ref. Holding Bracco Esaote)

8. EHR systems : legal/regulatory context Formal certification process is not in place in Italy. Most regional EHR infrastructures verify the ability of GP systems to fit local rules and approve their usage within the regional system. The main producers of GP systems made a consortium to self-certify the adherence of each system to a basic set of requirements. EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

9. EHR systems : legal/regulatory context the MoH established in 2001 a Steering Board with central government and regions to rule the New Nat’l Healthcare Information System (NSIS) and semantic interoperability. the Ministry of Innovation established in 2004 a eHealth Board (TSE) with MoH and regions to harmonise e-health policies Ministry of Innovation, Federation of Local Trusts and Municipalities (Federsanità-ANCI), Forum of Public Administration (ForumPA) and National Research Council (CNR) promoted a tool to monitor readiness and adoption of ICT in Local Trusts (LITIS – Levels of Technological Innovation in Healthcare). EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

10. EHR systems : legal/regulatory context The eHealth board (TSE) defines the normative and technical framework, IBSE, a national EHR federated infrastructure and IPSE (the mirror project of EPSOS). A law in the Parliament will formally establish the EHR also for secondary uses; a regulation will be produced after 6 months. EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

11. EHR systems: quality assessment Several Regional Authorities are establishing their regional eHealth Board, according to local rules and competence centers (e.g. Arsenal consortium among Local Trusts in the Veneto Region). Some Regional Authorities are developing eHealth roadmaps with EHR’s development (some based on European Structural Funds) EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

12. EHR systems: quality assessment EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

13. EHR systems: initiatives, plans List and present the public initiatives In March 2010, TSE began working on interoperability between different regional EHR, with the production of specific criteria (Good Practice Requirements) that indicate how to implement validation of the phases of integration, conforms at C1 “EHRS infrastructure component” and C10 “EHRS Interoperability component”. EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade

14. Closing slide Closing slide Contact data and web sites Angelo Rossi Mori, PROREC Italy arossimori@gmail.com arossimori@gmail.com TSE www.sanitaelettronica.gov.it/ NSIS www.nsis.ministerosalute.it/ EHR Systems Quality Labelling and Certification 21 - 22 November 2011, Belgrade