National Law No. 27.797 – Law on Healthcare Quality and Safety
Health Department – Life Sciences Department Report | National Law No. 27.797 – Law on Healthcare Quality and Safety
On October 8, 2025, Law No. 27.797 (the “Law” or the “Nicolás Law”) was published in the Official Gazette. Through this Law, the National Congress established a comprehensive framework for quality and safety in healthcare, aimed at preventing avoidable harm and ensuring safe medical care across all public and private health service institutions.
The provisions of this Law complement and are integrated with those of Law No. 26.529, which governs the rights of patients in their relationship with health professionals and institutions, and Law No. 27.275, which guarantees the right of access to public information, promoting citizen participation and transparency in public administration.
Below we highlight the key aspects introduced by the Nicolás Law:
1- Definitions: The Law defines a set of guiding concepts that frame its implementation and practical application, including quality of care, patient safety, quality management, health co-production, just culture, safety incidents, adverse and sentinel events, and quaternary prevention.
2- Objectives and Principles: The Law sets out objectives such as promoting quality management, ensuring transparency of information, identifying and analyzing risks with confidential reporting of incidents, encouraging citizen participation in institutions, upholding autonomy and health citizenship, fostering humane treatment, and providing cross-disciplinary, continuous training for health teams. These objectives are supported by principles of equity in access, autonomy, access to information, and a just culture.
3- Minimum Institutional Requirements: All health service providers must establish the means to implement protocols for preventing avoidable harm; audits and monitoring of patient safety indicators; self-assessment and external evaluation programs for quality certification; standardized care processes and surveillance of healthcare-associated infections; non-punitive systems for recording and investigating incidents, adverse events and sentinel events, with adoption of preventive measures; user-facing information tools, including complaint or objection mechanisms; appropriate staffing; work schedules that prevent fatigue; protective measures against violence or intimidation; and paid protected time for training and self-assessment.
The enforcement authority is tasked with taking appropriate measures to ensure these standards are adjusted to the type, scale, and level of care of each institution.
4- Unified Sentinel Event Registry (RUDEC): The Law creates RUDEC, integrated into the Argentine Integrated Health Information System (SISA), with confidentiality rules in line with personal data protection laws. Institutions registered in the Federal Registry of Health Facilities (REFES) must report sentinel events, and RUDEC must publish annual statistics aimed at learning and prevention.
5- Sanctions and Disqualifications: The Law mandates the consolidation of disciplinary sanctions and disqualifications in the Federal Network of Health Professional Registries (REFEPS), with public access, mandatory consultation by licensing authorities, and annual statistical reporting.
6- Verification of Professional Competence: The Law imposes mandatory, periodic verification of the professional competence of health personnel, based on specific skills and, where applicable, simulation-based assessments. Results must be recorded in REFEPS and are publicly accessible. If psychophysical limitations are detected, tasks must be reassigned to ensure continuity of the employment relationship.
7- Training of Health Teams: The Law requires periodic training in healthcare quality, patient safety, and health access legislation for all positions and roles, with mandatory inclusion in residency programs. These training courses must be reported to REFEPS for registration.
The enforcement authority at the national level will be designated by the National Executive Branch, and locally by each jurisdiction that adheres to the Law. The Nicolás Law will come into force 180 days after its publication and must be regulated by the Executive Branch within that same period.
Sincerely,