Adverse event reporting in healthcare-Regulatory frameworks, institutional governance, and economic implications with...

Adverse events constitute a major challenge not only for patient safety but also for the effectiveness, sustainability and equity of healthcare systems. The present analysis demonstrates that patient safety cannot be reduced to a purely clinical or legal issue, as adverse events generate substantial social and economic consequences that frequently extend beyond healthcare institutions and are borne by patients and their households. The findings indicate that the current Polish model of adverse event monitoring, based predominantly on internal reporting mechanisms within individual healthcare entities, provides limited opportunities for national learning, regulatory evaluation and evidence-based policy-making. The absence of a centralized adverse event register restricts the ability to assess the effectiveness of patient safety interventions, estimate the full social and economic burden of adverse events and identify systemic risk factors that require regulatory action. Effective reporting systems require an organizational culture based on trust, transparency and learning, supported by the principles of no-blame and just culture, which encourage incident reporting while maintaining accountability for reckless or intentional misconduct. Therefore, future reforms should focus on strengthening information infrastructure, improving data quality and comparability, and developing integrated national reporting systems that facilitate organizational learning and regulatory evaluation. The establishment of a central adverse event register, combined with transparent reporting mechanisms and systematic assessment of patient safety policies, could significantly improve both patient outcomes and the allocative efficiency of healthcare systems. Integrating legal and economic perspectives into patient safety governance is essential for designing regulations that adequately reflect the full social costs of adverse events and promote more resilient, equitable and patient-centered healthcare systems.