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Argentina’s Senate Enacts ‘Ley Nicolás’ to Overhaul Patient Safety

Regulatory rollout by health authorities is the next step.

Overview

  • The chamber approved the law 69–1, with only Senator Carmen Álvarez Rivero voting against it.
  • The statute mandates encrypted, interoperable digital medical records, periodic certifications for professionals and institutions, standardized care protocols, and audit and surveillance systems.
  • It creates the Unified Sentinel-Event Registry (RUDEC) to log serious incidents and publish investigation results to drive prevention.
  • Workforce safeguards include limits on shift duration, guarantees on staffing levels, and programs for self-evaluation to reduce exhaustion and avoidable errors.
  • Named for Nicolás Deanna, whose 2017 misdiagnosis galvanized family and NGO advocacy, the reform advances alongside a separate Senate vote granting initial approval to add spinal muscular atrophy to newborn screening, and was assessed as fiscally neutral by Congress’s budget office.