The Italian National Health Service is adopting Artificial Intelligence through its technical agencies, with the twofold objective of supporting and facilitating the diagnosis and treatment. Such a vast programme requires special care in formalising the knowledge domain, leveraging domain-specific data spaces and addressing data governance issues from an interoperability perspective. The healthcare data governance and interoperability legal framework is characterised by the interplay of different pieces of legislation. Data law is the first to be taken into proper account. It primarily includes the GDPR, the Data Governance Act, and the Open Data Directive. Also, the Data Act and the European Health Data Space proposals will have an impact on health data sharing and therefore must be considered as well. The platform developed by the Italian NHL will have to be integrated in a harmonised manner with the systems already used in the healthcare system and with the digital assets (data and software) used by healthcare professionals. Questions have been raised about the impact that AI could have on patients, practitioners, and health systems, as well as about its potential risks; therefore, all the parties involved are called to agree upon to express a common view based on the dual purpose of improving people's quality of life and keeping the whole healthcare system sustainable for society as a whole.

翻译：意大利国家卫生服务机构正通过其技术机构引入人工智能，其双重目标是支持并促进诊断与治疗。这一大规模项目需要在知识领域形式化、利用领域特定数据空间以及从互操作性角度解决数据治理问题方面给予特别关注。医疗数据治理与互操作性法律框架的特征在于不同法规之间的相互作用。数据法律是首要考虑因素，主要包括《通用数据保护条例》、《数据治理法案》和《开放数据指令》。此外，《数据法案》和欧洲健康数据空间提案也将对健康数据共享产生影响，因此必须予以考虑。意大利国家卫生服务机构开发的平台需要以协调方式与医疗系统中已使用的系统以及医疗专业人员使用的数字资产（数据和软件）进行集成。人工智能可能对患者、从业者和医疗系统产生的影响及其潜在风险已被提出质疑；因此，所有相关方被要求达成共识，基于改善人们生活质量与维持整个医疗系统对社会可持续性的双重目标，表达共同观点。