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Argentina Promulgates Law 27.797, the 'Nicolás Law,' to Overhaul Patient Safety

Inspired by a 2017 misdiagnosis case, it takes effect in six months under Health Ministry oversight.

Overview

  • The law was published in the Boletín Oficial, starting a 180‑day countdown to entry into force and to the Executive’s implementing regulations.
  • It creates the Unified Registry of Sentinel Events (RUDEC) for confidential, non‑punitive reporting of adverse events across the health system.
  • Professional sanctions must be recorded in the Federal Registry of Health Professionals (REFEPS), and any suspension or disqualification will apply nationwide.
  • All jurisdictions must deploy interoperable electronic medical record platforms within four years to enable secure information sharing.
  • The framework mandates standardized protocols, audits, continuous training and worker‑safety measures rooted in a 'just culture,' following Senate approval by 69–1.