art_44__para_3

3. Where a market surveillance authority finds that an EHR system has caused harm to the health or safety of natural persons or to certain aspects of public interest protection, the manufacturer shall immediately provide information and documentation, as applicable, to the affected natural person or user and, where applicable, other third parties affected by that harm, without prejudice to data protection rules.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.