Artificial intelligence in healthcare: Europe at the test between regulation and push for innovation

At a time of great promise for digital health, Europe is wondering how to govern artificial intelligence without hindering innovation. Healthcare is perhaps the most complex challenge, because it combines the highest expectations with the strongest caution, given the importance of what is at stake and the sensitivity of the data involved. Certainly, the European Commission has been quite prolific in producing regulations in this regard. In the European context, in fact, an ambitious regulatory framework is being consolidated to govern the development of digital technologies in healthcare.

In addition to the AI Act, already formally in force since August 2024, there are key instruments such as the Medical Device Regulation (Mdr) and the European Health Data Space project, which defines the conditions for access, use and interoperability of health data. This regulatory production testifies to a clear will to promote digital innovation while safeguarding rights, safety and quality of care.

However, the widespread perception among national governments, businesses, healthcare professionals and citizens is often that of regulatory fragmentation. The succession of initiatives and instruments that are still apparently disconnected from each other feeds the impression of moving in a siloed regulatory environment, where each evolutionary device follows its own logic and there is a lack of unified direction. The consequence is that many actors perceive that they move surrounded by varying degrees of uncertainty and this hinders them in contributing to the transfer of digital health innovation from the world of experimentation to the real world.

In this context, in fact, many areas of digital innovation in healthcare have seen a significant reduction in investment in 2023-2024 compared to the euphoria shown in the tail end of the pandemic period. This phenomenon can be explained above all in the light of the illusion that the Covid period generated especially in digital health, namely that any innovation would have its way regardless of, or even irrespective of, its risks.

However, and somewhat fortunately, European healthcare systems have shown the rationality to understand that an effective and safe diffusion of these technologies is only possible if technological, managerial, regulatory and cultural complementarities are activated. The European Commission is fully aware of the disorientation perceived by stakeholders and is working to promote a coherent design and strengthen a systemic vision that accompanies innovation without hindering it, opening itself above all to dialogue with the system's actors.