Survey, potential and critical points of Italian and European legislation on data protection in the biomedical field, particularly in light of the additions/revisions introduced in the 2024-2025 period

Privacy in our country is governed by two key regulations: i) the General Data Protection Regulation (GDPR) “Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data,” which entered into force simultaneously in all EU countries on May 25, 2018 and ii) the Legislative Decree 196/2003 “Code regarding data protection and ethical rules,” amended and supplemented by Legislative Decree 101/2018 “Provisions for the adaptation of national legislation to the provisions of Regulation (EU) 2016/679.”These measures include various specific points concerning health data and related studies, which over the years have become part of the knowledge base of the scientific community, particularly in the biomedical and epidemiological fields, albeit with some critical issues remaining.After several years of “run-in” the application of these regulations in the above-mentioned area, additions/amendments have been made in the period 2024-2025, in both national and European measures, such as: Some amendments to Article 110 of the Privacy Code, Clarifications by the National Data Protection Supervisor on the use of personal data by IRCCS (Scientific Institutes for Research, Hospitalization, and Healthcare), National Digital Health Ecosystem, [EU] Health Data Space.Measures have been issued (and are in the process of being fully implemented) that interact with privacy regulations, such as the Decree on the Digitization of Birth and Death Data.In addition, a review of the Data Protection Regulations for Scientific Research has been initiated, and a law on Artificial Intelligence was approved.These topics are developed in this article, accompanied by links to the original texts cited; moreover indeptharticles are also indicated.