serious incident

‘any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly leads, might have led or might lead to any of the following: (i) the death of a natural person or serious harm to a natural person’s health; (ii) serious prejudice to a natural person’s rights; (iii) serious disruption of the management and operation of critical infrastructure in the health sector; (30) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). 32/96 ELI: http://data.europa.eu/eli/reg/2025/327/oj’

Questions about what this term means for your organisation? Contact Mr. Dr. Vlieger.