This is no simple activity report. The 2025 annual report from the Health Authority (Authority Sanitaria) lays out a series of critical issues affecting the functioning of San Marino’s healthcare system, from relations with the ISS (Istituto per la Sicurezza Sociale) to accreditation rules, sanctions, and the management of adverse events.
As reported by San Marino RTV, one of the most sensitive issues concerns the availability of health data. According to the Authority, the absence of a specific collaboration protocol with the ISS Epidemiological Observatory severely limits its work. The report also notes that “often, even during 2025, access to ISS health data was denied or the requested data was not provided.” The body also states it was not involved in the planning or verification of ISS objectives set out in health programming.
Several regulatory issues remain unresolved as well. The Authority points to a misalignment with Italian legislation on accreditation: in San Marino, it would only be possible to issue provisional accreditations. A proposal to update Delegated Decree 115/2008, submitted to the Secretariat of State for Health in 2022, has reportedly still not been considered, according to the report. Concerns are also raised regarding Delegated Decree 50/2024 on economic activities, which is said to have produced conflicting rules and operational difficulties for healthcare professionals.
Another chapter concerns sanctions. The current system is described as essentially “ON/OFF”: it moves from a simple warning to severe measures such as suspension or closure of activity, with no adequate intermediate tools. The Authority therefore intends to resubmit to the Executive a set of administrative sanction regulations that was already presented in the previous legislature but subsequently lapsed. Action is also being requested on medicines, medical devices, narcotics and medical cannabis, with a proposal to establish a dedicated office.
Finally, the report captures the state of patient safety. In 2025, 38 adverse events were recorded: 18 at the ISS and 20 in private facilities. Within the ISS, a sentinel event was also detected — an episode of particular severity requiring investigation to identify its causes and underlying issues.
Meanwhile, 13 compensation claims remained pending in 2025, all against the ISS. The Authority underscores the significant variability in reports coming from the public healthcare system: adverse events numbered 90 in 2020, 65 in 2021, 27 in 2022, and 71 in 2023. According to the body, this fluctuation suggests that the monitoring and reporting system has not yet been sufficiently embraced by ISS staff and requires greater attention.
