The proposal for a regulation on the EHDS was launched in 2022 in the framework of the 'European strategy for data'. The EHDS seeks to provide rules, common standards and practices, infrastructures, and a governance framework for both types of uses of public health data:

• primary use of health data, to support or provide direct individual healthcare delivery to the data subject;
• secondary use of health data to support research, innovation and policy making.

The 2024 trialogue negotiations on EHDS reveal many diverging views between the European Council and the European Parliament regarding issues critical for research and innovation. Moreover, LERU fears that the political ambition to find a compromise and final decision before the European elections might lead to a questionable quality of the conclusions on key issues. LERU therefore contributes to the institutional debate by highlighting common and grounded concerns and recommendations of its members in a statement, aiming to safeguard scientific research carried out by universities and university hospitals.

The statement covers nine key messages:

1. Clarify the definition of scientific research.
2. Clearly define all data categories that will be subject to a sharing mandate.
3. Ensure consistency with other legislative EU-frameworks.
4. Ensure consistency between the opt-out mechanism under the EHDS and the rights of data subjects under the GDPR.
5. Ensure coordination between the national health data access bodies and the EHDS Board.
6. Avoid a negative impact of EHDS provisions on technology transfer activities.
7. Clarify the legal principles of how to share research results to healthcare purposes.
8. Provide sufficient time, support, and funding for the implementation, considering the inequalities between the countries, and the need to raise awareness among citizens and legal entities on the new regulation.
9. Provide clear guidelines for data holders on what is required of them as data holders.