Why the Spanish Security Framework (ENS) is a must-to-know in healthcare sector even if you are not based in Spain?

Table of Contents

What is it ?

It is the cornerstone of information security in Spain and a mandatory legal requirement for any company collaborating with the Public Administration directly or indirectly.

Its official website managed by Spanish National Cryptologic Centre (CCN-CERT) has documentation and online resources as:

  • security policies templates,
  • standard operating procedures (SOPs) templates,
  • security guidelines at different levels and adapted to many technologies.

Serving as a valuable source even if you are implementing another type of cybersecurity regulation.

https://ens.ccn.cni.es/en

Essential Resources for the Healthcare Sector

The Spanish National Cryptologic Centre (CCN-CERT) offers specific guides to facilitate compliance in the health field:

Security requirements for E-health Applications (CCN-STIC 857): For solution providers and healthcare software architects and developers.

Specific Compliance Profile for Health (CCN-STIC 891): Practical guide for adherence to the ENS in the provision of healthcare services to patients (Primary and Specialized Care).

Synergies with the European Legal Framework

ISO 27001

The ENS is inspired by the ISO 27000 family of standards, making it easier for companies to integrate both security management frameworks. Mapping between the ISO 27001:2022 Standard and the RD

NIS / NIS2 & Cybersecurity Act

The ENS is the primary security framework in Spain. Its compliance lays the foundation security requirements mandated by the NIS and NIS2 Directive.

GDPR The ENS demands the rigorous technical measures necessary to protect personal data and, thus, is the mechanism for materializing the security obligation established by the GDPR.

Mandatory Scope

  • Public Sector: It is mandatory for all General State Administration, Autonomous Communities, and Local Entities.
  • Collaborating Suppliers: It applies to all suppliers and companies that collaborate with the Public Sector.
It affects you even without a direct contract with the Spanish Public Administration because a key feature is its strong focus on supply chain security.

Critical Focus: The ENS in the Healthcare Sector

Compliance is required from:

  • Health Services: Hospitals, health centers and regional health services.
  • Healthcare Information Technology Providers: Any company that manages, processes, or maintains patient information (electronic health record systems, appointment platforms, laboratory information systems etc.).

Certification Requirement

Since health data is a special category of data, systems must be categorized as minimum MEDIUM or HIGH security category.

For Medium and High-category systems, the ENS requires the implementation of a Security Management System that must be validated through an external audit, with a minimum frequency of every two years.