The authority, in the opinion expressed, calls for greater guarantees for data protection.
Il opinion it was formulated on a draft decree which defines the modalities of access to the prescriptions of medicines issued in the Italian territory to patients who intend to use them in another Member State of the European Union.
The Guarantor, recalling the need to ensure reinforced protection of health data, provided precise indications to the Ministry of Health to overcome the various critical issues present in the text in its opinion.
According to the website of the Guarantor “in particular, it will be necessary to reformulate and better clarify the relationships between the various subjects (prescribing doctors, Ministry of Health, Ministry of Economy and Finance, etc.) involved in the process of generating and using the cross-border prescription, specifying the ownership of the treatments data. The scheme must better specify the information to be provided to the interested party and indicate the correct legal basis and the reason of significant public interest that allow the processing of the data and must specify the operations that can be performed and the appropriate protections envisaged for the fundamental rights of the interested parties”.
“The Ministry will also have to bring into line with the indications of the Guarantor, also made with a previous opinion (August 22, 2022, n. 294), the methods through which the Health Card System makes data available to Electronic Health Records and pharmaceutical dossiers through the national infrastructure. Finally, the subjects who can access it and for what purposes will have to be specified. In order to guarantee the quality and security of the information, appropriate measures must also be taken, such as, for example, the preventive impact assessment”.