From Criminal Liability to Patient Safety: The Possible Impact of the Italian 2025 Reform Proposal on Senior Healthcare Leadership and Clinical Risk Management.

This article analyses the Italian Legislative Delegation Bill of 4 September 2025 (DDL 2025), which proposes the recontextualization of healthcare liability through the introduction of Article 590-septies into the Italian Criminal Code (c.p.) and the amendment of Article 590-sexies c.p. and of Articles 5 and 7 of the Gelli-Bianco Act (Law No. 24/2017). The study examines the extent to which the reform, if enacted, would produce a shift of criminal negligence liability from the individual frontline clinician towards the apex management figures of healthcare organizations-at both the corporate and hospital levels-and under what conditions such a shift would be compatible with the constitutional principle of personal criminal responsibility (Art. 27 Const.) and with the evidentiary criteria for criminally relevant omission. Adopting a doctrinal and jurisprudential analysis approach, the study formulates a falsifiable hypothesis, accompanied by four ex post verifiability indicators observable over a five-year time horizon following the possible entry into force of the provision. The analysis demonstrates how the DDL 2025 would recontextualize the notion of culpa-encompassing imperizia (lack of skill), negligenza (negligence), and imprudenza (imprudence), functionally comparable to forms of criminal negligence in common law systems-by linking fault assessment to contextual factors such as organizational deficiencies and resource scarcity. This approach would adopt a deflationary framework, establishing a distinction between avoidable human error and errors caused by systemic dysfunctions and foreshadowing a potential shift of liability towards apex management, who are required to ensure organizational models adequate to patient safety. This orientation, far from constituting a doctrinal novelty, would formalize ex lege a trajectory already established in civil and criminal case law of the Court of Cassation (Cass. No. 6386/2023, "Travaglino"), further intersecting with the administrative liability regime for organizations under Legislative Decree 231/2001. Significant interpretive challenges remain, related to the application of criminal liability criteria to the omissive conduct of healthcare managers, as well as to the contrasting international evidence on the behavioural effectiveness of medical liability reforms. The redefinition of top-management liability would therefore be configured not merely as a tool for the protection of the individual professional but as a derived constitutional guarantee of the right to health and the safety of care, pursued through formalized risk governance, the integration of incident reporting and organizational audit systems, the transition towards Enterprise Risk Management models, and the traceability of apex decision-making processes. Examples drawn from other European jurisdictions illustrate the heterogeneity of legal approaches to medical fault and frame the Italian proposal as a context-specific solution that nonetheless could contribute to the international debate on institutional and organizational accountability for patient safety.