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) 44(7): Report serious incidents involving an EHR system within three days

Article 44(7) and (3): manufacturers report any serious incident (malfunction or deterioration that led or might lead to death or serious harm to health, serious prejudice to rights, or serious disruption of health critical infrastructure) to the market surveillance authorities where it occurred and where the system is on the market, with the corrective action taken or planned, immediately after establishing a causal link or its reasonable likelihood and no later than three days after becoming aware, without prejudice to NIS 2 notification; where a system caused harm, the manufacturer immediately gives information to the affected persons and users.

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

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