Electronic health record, from Lombardy to Emilia Romagna: privacy guarantor intervenes
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 discipline on FSE 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 to 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. According to the Authority, “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, precisely to protection of patients, are not guaranteed uniformly throughout the country. Or they are exercisable and payable only by the patients of certain Regions and autonomous Provinces, with a potential and significant discriminatory effect on the patients”. This lack of homogeneity “also contradicts the spirit of the ESF 2.0 reform aimed at introducing measureshomogeneous guarantees and responsibilities throughout the national territory, thus also risking compromising the functionality, interoperability and efficiency of the FSE 2.0 system”. The violations in which the Regions and autonomous Provinces have incurred, with different levels of severity and liability, may lead to the application of the sanctions provided for by the European Regulation.
The electronic health record (EHR) is the digital folder that should relaunch the National Health Service by making doctors’ access to information during diagnostic visits, specialist tests or emergency situations more efficient and homogeneous.
Electronic health record, what it is and what it contains
The ESF 2.0 contains the following data and documents, also referring to services provided outside the National Health Service:
identification and administrative data of the patient (exemptions for income and pathology, contacts, delegates), reports, emergency room reports, discharge letters, summary health profile, specialist and pharmaceutical prescriptions, medical records, provision of drugs paid by the NHS and not by the NHS SSN, vaccinations, provision of specialist assistance services, personal notebook of the patient, card details for implant recipients, letter of invitation for screening.
The synthetic health profile, or ‘patient summary’, is the IT socio-health document drawn up and updated by the general practitioner or paediatrician of free choice which summarizes the patient’s clinical history and his current known situation. The purpose of the summary health profile is to promote continuity of care.
The patient’s personal notebook is a reserved section of the ESF within which the citizen can independently insert, modify, integrate and delete personal data and documents relating to their treatment paths. This information is, obviously, distinct from the others as it is not certified by healthcare professionals and the patient can choose whether and to whom to make it visible.
Electronic health record, who can object and how to do it
For those who have not yet done so, the opposition to the uploading of data and documents generated by clinical events referring to services provided by the National Health Service prior to 19 May 2020 must be made via the Health Card System portal at www.sistemats.it . The choice can be revoked and re-registered in the health card system several times, until June 30th. The system will select the last indication loaded chronologically. Failure to access the “Fse – Opposition to previous” online service or access to the service without registering your opposition – warns the ministry – will result in the automatic uploading of your data and health documents available and prior to 19 May 2020 in the ESF.
Citizens with health care or foreigners temporarily present in Italy can object to the precedent. The online service can be accessed with digital identity tools (Spid, electronic identity card, national services card), or with a health card and STP code (Temporarily Present Foreigner). People who do not have the possibility of digital access can be assisted by authorized intermediaries at their local health authority or by flight or aviation personnel at the Usmaf-Sasn clinics of the Ministry of Health
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