EHDS, Article 59, SE

1. Each health data access body shall publish an activity report every two years and make it publicly available on its website. If a Member State designates more than one health data access body, the coordinating body referred to in Article 55(1) shall be responsible for the activity report and request the necessary information from the other health data access bodies. That activity report shall follow a structure agreed by the EHDS Board pursuant to Article 94(2), point (d), and contain at least the following categories of information:

(a)

information relating to the health data access applications and health data requests submitted, such as the types of health data applicants, number of data permits issued or refused, categories of purposes of access and categories of electronic health data accessed, and a summary of the results of the electronic health data uses, where applicable;

(b)

information on the fulfilment of regulatory and contractual commitments by health data users and health data holders, as well as the number and amount of administrative fines imposed by health data access bodies;

(c)

information on audits carried out on health data users to ensure compliance of the processing they carry out in the secure processing environment pursuant to Article 73(1), point (e);

(d)

information on internal and third-party audits on compliance of secure processing environments with the defined standards, specifications and requirements, as referred to in Article 73(3);

(e)

information on the handling of requests from natural persons relating to the exercise of their data protection rights;

(f)

a description of the health data access body’s activities carried out in relation to engagement with and consultation of relevant stakeholders;

(g)

Official source

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