The Privacy Guarantor has notified 18 Regions and the two autonomous Provinces of Bolzano and Trento of the initiation of “corrective and sanctioning procedures” for the numerous violations found by the Authority in the implementation of the regulation on the electronic health record 2.0 (of which to the ministerial decree of 7 September 2023). This was made official by a note released yesterday by the Guarantor and faithfully reported by the main press outlets. «In the previous days», writes the Guarantor, «the serious situation and the urgency of corrective interventions had been reported to the President of the Council of Ministers and to the Minister of Health».
The investigation started at the end of January, the press release continues, “has shown that 18 Regions and the two autonomous Provinces of Trentino Alto Adige 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 have made it clear that some rights (blackout, delegation, specific consent) and measures (security, differentiated levels of access, data quality), introduced by the decree to protect patients, “are not guaranteed uniformly throughout the country, or can be exercised and enforced only by patients in certain Regions and autonomous Provinces, with a potential and significant discriminatory effect”.
This lack of homogeneity, the Guarantor continues, contradicts the spirit of the reform of the ESF 2.0, aimed at introducing homogeneous measures, guarantees and responsibilities throughout the national territory, and therefore risks compromising the functionality, interoperability and efficiency of the system. “The violations incurred by Regions and Autonomous Provinces with different levels of severity and responsibility” concludes the Guarantor Authority “may lead to the application of the sanctions provided for by the European Regulation”.
