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ENS (Esquema Nacional de Seguridad)

Overview​

vitalera complies with the Esquema Nacional de Seguridad (ENS), the Spanish National Security Framework that establishes security requirements for information systems used by public sector organizations in Spain.

Relevance​

ENS compliance is required for healthcare organizations in the Spanish public health system (e.g., Osakidetza, SACYL, SCS) that use vitalera for remote patient monitoring. This ensures that patient vital signs, clinical observations, and health data collected via the FHIR R5 API and medical device SDKs are processed in accordance with Spanish national security requirements.

Security Categories​

ENS defines three security categories (Basic, Medium, High) based on the impact of a security incident. vitalera's implementation addresses requirements across all relevant categories.

Key Controls​

  • Information classification and handling
  • Access control and authentication
  • Communications security
  • Incident management
  • Business continuity
  • Audit and accountability