In the wake of the European Regulation on AI (AI Act), the Council of Ministers held on April 23 approved the bill "Principle Rules on Artificial Intelligence" for the introduction of provisions concerning the use of such systems on the Italian territory, with particular reference to those specific sectors in which the use of artificial intelligence could have a
significant impact on a social and economic level.
One of the most sensitive areas in this sense is surely healthcare, a particular sector that finds precise treatment within the bill, to which no less than 3 articles are dedicated.
Specifically, Article 7 of the bill, it is stipulated how the use of Artificial Intelligence systems may not select and condition, access to health services with criteria that discriminate against citizens or be such as to restrict access to health services. Also in that article, the right of data subjects to be duly informed about the use of AI technologies that affect them and to receive information about the decision-making logic used is emphasized. The use of AI systems in health care must always play a supporting role in prevention, diagnosis, treatment, and therapeutic choice, while the physician's responsibility regarding the final decision on the specific treatment remains unaffected. Finally, artificial intelligence systems used in healthcare and the related data employed must be reliable periodically verified, and updated to minimize the risk of errors.
Article 8 intervenes on the subject of research and scientific experimentation in the realization of artificial intelligence systems in healthcare. Data processing, including personal data, carried out by public and private nonprofit entities for research and scientific experimentation in the realization of artificial intelligence systems for therapeutic and pharmacological purposes, is declared to be of significant public interest (according to Article 9(g) of the GDPR). Such processing, therefore, may disregard the consent of the data subjects as long as specific security measures are taken and appropriate information is provided to them.
Finally, in Article 9, the bill introduces provisions regarding the electronic health record and digital health management. It is planned to create an AI platform managed by the National Agency for Regional Health Services (AGENAS), dedicated to the support of health professionals and users.