Researchers work with data—data about phenomena, evolutions, and often individuals. You might be using hypothesis-driven methodologies or exploring discovery-driven methods. The data might be gathered in a controlled environment or from real-life situations. In every scenario, you are responsible for safeguarding this data while using it for your research.

 

Whether you are collecting data directly from research participants or retrieving it directly from existing datasets, the identity of these participants are typically known. Even when the name or identity number is irrelevant to your research, you may be legally required to keep track of your participants: to inform them about data processing, to allow them to exercise their fundamental rights, to notify them about incidental findings,… Obligations that may cause you to qualify as a data controller. Moreover, even if you are not processing personal data, legal requirements may still apply, for instance, due to being identified as a data holder.

 

This session focuses on the regulatory and policy requirements for working with data in a research context, particularly within the healthcare sector. We will discuss your responsibilities as the custodian of the datasets you work with, including the skills to distinguish personal data from non-personal data. Additionally, we will cover the latest legislative developments, such as the European Health Data Space Regulation and the AI Act, and understand how they impact your research. Finally, we will delve into specific requirements for using big data in healthcare research.