Discussion of innovation in medicine offers an opportunity to more fully explore the management of health data as a strategic resource for improving the national healthcare system (SSN) by optimizing scientific research, precision medicine and efforts at prevention.
Participants noted both the potential and the limitations of the current Italian SSN approach to the use of personal data; in particular, the limitations on data use imposed by a legal framework that does not sufficiently balance the right to privacy with the public interests of research and innovation. Balancing privacy protection and innovation is proving to be a key challenge, especially when excessive protection risks slowing a public health project that has tangible benefits for all citizens. Many medical initiatives aimed at prevention and proactive treatment have run aground due to privacy issues, which highlights the need for a regulatory framework that permits the use of data for the good of medical progress without sacrificing security. Moreover, it is possible to question the efficacy of instruments such as informed consent with regard to the protection of privacy and effective involvement of the patient in the treatment of their data, particularly in consideration of physician/patient informational asymmetry.
Europe has made significant progress in facilitating the use of health data for the public interest, introducing the concept of “legitimate interest” as the legal basis for consent of the secondary use of data for the purposes of research and innovation. This has led to a new phase in which consent no longer provides the only legal grounds for accessing data, thus overcoming the limitations of traditional consent and making it possible to place increased importance on the collective utility of scientific research. The result is a culture that goes beyond the individualistic proprietary concept of data to consider them a shared resource, thereby creating new prospects for national health.
The situation in Italy is made more complex by regulatory fragmentation at regional level, which limits overall system efficiency. A glaring example of this is the Electronic Health Record (EHR) implemented by means of approaches and technologies that differ from region to region.
Legislative harmonization at the national level is therefore an indispensable step in building a fully integrated health network in which telemedicine and a health data ecosystem can ensure assistance and treatment continuity to all citizens. Of major importance would be innovative national governance models capable of uniformizing data access rules and ensuring full interoperability (technical, infrastructural, semantic and legal). Only through robust national governance – and only by making the best use of the crucial next few years before the new European technical and legal regulatory framework for experimentation (sandbox) goes into effect – will Italy be able to reinforce its national health data ecosystem as a driver of the SSN’s digitalization and competitiveness. That would make it possible to take full advantage of the potential deriving from the implementation of recent European regulatory innovations such as the Data Act, the Data Governance Act, the European Health Data Space and the AI Act.
As regards the role of artificial intelligence (AI) in medicine, this technology is viewed as indispensable for optimizing diagnoses and improving the healthcare plan. From the standpoint of technological maturity, it emerges that AI is already proving its usefulness in spheres such as CT and MRI imaging, thus making diagnosis faster and more effective; nevertheless, its use raises issues regarding data governance and ethical liability, in addition to requiring new training models for doctors and other healthcare personnel.
Public/private collaboration aimed at maximizing the efficacy of available resources also remains fundamental. Private facilities play a key role in the dissemination of telemedicine and telemonitoring, eliminating current lacunas in access and supporting the SSN in the adoption of advanced technological solutions. They can also experiment with new economic models by which to sustain the adoption of these innovative systems.
In conclusion, it is clear that the journey toward a data-based healthcare system calls for a collective commitment, from the legal but also the cultural and technological standpoint. Only by means of the coordination of regional and national entities, continuous collaboration with privacy authorities, elimination of regulatory fragmentation and greater receptiveness to the use of data for the public interest will it be possible to create a truly innovative, accessible and sustainable healthcare system.