Regulation on the European Health Data Space (EHDS)
EHR systems: requirements and economic operators – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 104: Use the EHDS conformity route to show Cyber Resilience Act conformity for EHR systems

Article 104 amends Regulation (EU) 2024/2847: manufacturers of products with digital elements classified as EHR systems demonstrate conformity with the Cyber Resilience Act essential requirements using the EHDS Chapter III conformity assessment procedure, include the cybersecurity risk assessment in the technical documentation (which may form part of the risk assessment required by other acts) with justification for any inapplicable requirement, and keep a single set of technical documentation covering both acts.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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