EHDS, Article 64, SE

1. Each health data access body shall ensure that the imposition of administrative fines pursuant to this Article in respect of infringements referred to in paragraphs 4 and 5 is effective, proportionate and dissuasive in each individual case.

2. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or instead of, enforcement measures referred to in Article 63(3) and (4). Health data access bodies shall decide whether to impose an administrative fine and the amount of the administrative fine in each individual case by giving due regard to the following circumstances:

(a)

the nature, gravity and duration of the infringement;

(b)

whether any penalties or administrative fines have already been imposed by other competent authorities for the same infringement;

(c)

the intentional or negligent character of the infringement;

(d)

any action taken by the health data holder or health data user to mitigate the damage caused;

(e)

the degree of responsibility of the health data user, taking into account technical and organisational measures implemented by that health data user pursuant to Article 67(2), point (g), and Article 67(4);

(f)

any relevant previous infringements by the health data holder or health data user;

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