Articles of the European Health Data Space (EHDS), Article 39, Reporting by health data access bodies

Article 39, Reporting by health data access bodies, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Each health data access body shall publish an annual activity report which shall contain at least the following:

(a) information relating to the data access applications for electronic health data access submitted, such as the types of applicants, number of data permits granted or refused, 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) a list of data permits involving access to electronic health data processed by the health data access body based on data altruism and a summary description of the general interests purposes pursued, where applicable, including the outcomes of the data permits granted;

(c) information on the fulfilment of regulatory and contractual commitments by data users and data holders, as well as penalties imposed;

(d) information on audits carried out on data users to ensure compliance of the processing with this Regulation,

(e) information on audits on compliance of secure processing environments with the defined standards, specifications and requirements;

(f) information on the handling of requests from natural persons on the exercise of their data protection rights;

(g) a description of its activities carried out in relation to engagement with and consultation of relevant stakeholders, including representatives of natural persons, patient organisations, health professionals, researchers, and ethical committees;

(h) information on cooperation with other competent bodies in particular in the area of data protection, cybersecurity, data altruism, and artificial intelligence;

(i) revenues from data permits and data requests;

(j) satisfaction from applicants requesting access to data;

(k) average number of days between application and access to data;

(l) number of data quality labels issued, disaggregated per quality category;

(m) number of peer-reviewed research publications, policy documents, regulatory procedures using data accessed via the EHDS;

(n) number of digital health products and services, including AI applications, developed using data accessed via EHDS.

2. The report shall be transmitted to the Commission.

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of the annual activity report.