THIS REGULATION HAS NOT BEEN AGREED ON, YET; IT IS STILL A PROPOSAL WHICH HAS NOT EVEN REACHED THE TRILOGUE STAGE (status September 2023).
The European health data space aims at:
Primary use:
- safe exchange of patients’ data
- citizens’ control over their health data;
- support digital health services.
Secondary use:
- support research on treatments, medicines, medical devices and outcomes;
- access to and use of health data for research, policy-making and regulation,
This is supposed to be reached withing a sutiable infrastructure, a trusted governance framework and upholding data-protection rules. Another purpose is to clarify the safety and liability of artificial intelligence in health.
Key points of the current discussion are:
- technical features, such as cybersecurity and interoperability of the digital infrastructure;
- legal features, such as a precise definition of the scope and modalities of the secondary use, as well as the balance between privacy and the use and re-use of health data.