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Argentina Promulgates 'Ley Nicolás' to Establish National Patient-Safety Framework

The new statute shifts Argentina to a non-punitive, systemwide approach to patient safety.

Overview

  • The measure was published Wednesday in the Boletín Oficial following its September approval in Congress.
  • It creates the Unified Registry of Sentinel Events (RUDEC) to confidentially report and investigate safety incidents under a non-punitive model with required responses.
  • Professional suspensions or disbarments will now apply nationwide, with notifications routed through the federal registry of health professionals.
  • All jurisdictions must implement interoperable digital clinical histories within four years to enable secure information sharing.
  • The law takes effect in 180 days, and the executive branch must issue implementing regulations within the same period.