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NIS-2 Directive and Laboratory Medicine

The NIS 2 Directive is an important EU regulation that aims to ensure a high level of cybersecurity throughout the European Union¹. It is the successor to the first NIS Directive and introduces some significant innovations that must be transposed into national law by October 2024¹. For medical laboratories, this means they must prepare for stricter security requirements. Here are some key aspects that medical laboratories should consider: 1. Risk Management: Medical laboratories must implement comprehensive risk management that identifies, assesses, and takes appropriate protective measures against cyber threats?.   2. Reporting Procedures: A procedure must be established to properly report security incidents to the competent authorities?.   3. Business Continuity: Laboratories must develop business continuity plans to maintain operations in the event of a cyber incident?.   4. Management Responsibility: Management is responsible for compliance with the directive and must ensure that all requirements are met?.   5. Cooperation with…