© Adnkronos
It is urgent to intervene to protect the rights of all Italian patients involved in the processing of health data carried out through the Electronic Health Record 2.0. With this motivation, the Privacy Guarantor has notified 18 Regions and the autonomous Provinces of Bolzano and Trento of the initiation of corrective and sanctioning procedures for the numerous violations found in the implementation of the new regulations on the ESF 2.0, introduced with the decree of the Ministry of Health of 7 September 2023. In the previous days, the serious situation and the urgency of corrective interventions had been reported to the President of the Council of Ministers and the Minister of Health.
The results of the preliminary investigation activity on the ESF, started at the end of January, showed that 18 Regions and the two autonomous Provinces of Trentino Alto Adige, not being in line with what is contained in the decree of 7 September 2023, have modified, even significantly, the information model prepared by the ministry, following the opinion of the Guarantor, which should have been adopted throughout the national territory.
The discrepancies found made it clear that some rights (e.g. blackout, delegation, specific consent) and measures (e.g. security measures, differentiated access levels, data quality) introduced by the decree, specifically to protect patients, are not guaranteed uniformly throughout the country. Or they are exercisable and payable only by the beneficiaries of certain Regions and autonomous Provinces, with a potential and significant discriminatory effect on the beneficiaries.
This lack of homogeneity also contradicts the spirit of the ESF 2.0 reform aimed at introducing homogeneous measures, guarantees and responsibilities throughout the national territory, thus risking compromising the functionality, interoperability and efficiency of the ESF 2.0 system. The violations committed by Regions and autonomous Provinces, with different levels of severity and responsibility, may lead to the application of the sanctions provided for by the European Regulation.
Source
