2.5. Publishing results (finalisation)
The data user publishes the research results within 18 months, always anonymously, and informs the HDAB accordingly. The publication states that the results are based on data from the European Health Data Space (EHDS).
When there is an important finding concerning an individual, the data user reports this to the HDAB. The further handling and any communication to the person concerned takes place in accordance with the EHDS agreements and national rules. Those national rules determine whether and how a person is informed, and whether this is done directly or via the treating healthcare provider.
2.5.1. Overview of use cases
It is an assumption that the reporting of results will take place via the DAAMS.
Figure 7. Overview of the use cases for publishing the results.
The use cases from the diagram are briefly described in the following sections.
2.5.2. Report publication of research results
After the analysis in a secure processing environment has been completed, or after the requested health data has been received, the data user must, in accordance with Article 61(4), publish the anonymised research results within 18 months and inform the HDAB accordingly. The publication must also state that the results were obtained using data within the framework of the European Health Data Space (EHDS).
2.5.3. Report significant finding concerning an individual
A data user must, as laid down in Article 61(5), inform the HDAB of all significant findings related to the health of the person whose data was used in a dataset for research.
2.5.4. Register and deliver significant finding concerning an individual
Part of the delivery process is directly laid down in the EHDS Regulation. The responsibilities regarding the forwarding and handling of significant findings are set out in Articles 61(5) and 58(3). The role assigned to the HDAB in this process has been further elaborated in the TEHDAS2 guidelines. Other parts of the process fall under the responsibility of the Member States. Support in identifying significant findings aligns with the implementation of Article 94(2)(c), while the ultimate rules regarding informing persons concerned are determined at national level, in line with recital 67 of the Regulation.
In the communication to the person concerned, national rules play a decisive role. These determine whether and how contact may take place between the holder of the health data and the data subject, or their treating healthcare provider. For example, a person may have chosen not to be informed, or it may have been recorded that a significant finding must first be communicated via the treating healthcare provider. These choices and safeguards are designed to handle sensitive information with due care, as also emphasised in recital 67.