The League of European Research Universities publishes a series of recommendations on the European Health Data Space
The League of European Research Universities (LERU) has recently made public its position on the proposal for the European Health Data Space (EHDS) new regulation, which is being worked on by the European Parliament and the Council. This regulation aims to provide with rules, common standards, practices, infrastructures and a governing framework for the use of health data. In this sense, LERU, a key agent in research, innovation and higher education in Europe, has sent the legislators a series of recommendations to protect the research carried out at the universities and their hospitals.
The League of European Research Universities (LERU) has recently made public its position on the proposal for the European Health Data Space (EHDS) new regulation, which is being worked on by the European Parliament and the Council. This regulation aims to provide with rules, common standards, practices, infrastructures and a governing framework for the use of health data. In this sense, LERU, a key agent in research, innovation and higher education in Europe, has sent the legislators a series of recommendations to protect the research carried out at the universities and their hospitals.
The regulation aims to focus on two aspects: the primary use of health data, to provide direct individual healthcare to the data subject, and the secondary use of health data in the field of research and innovation. The LERU statement sets out nine key messages:
- Clarify the definition of scientific research.
- Clearly define all data categories that will be subject to a sharing mandate.
- Ensure consistency with other legislative EU-frameworks.
- Ensure consistency between the opt-out mechanism under the EHDS and the rights of data subjects under the General Data Protection Regulation (GDPR).
- Ensure coordination between the national health data access bodies and the EHDS Board.
- Avoid a negative impact of EHDS provisions on technology transfer activities, hampering collaborative research, licensing models, or spin-off creation.
- Clarify the legal principles of how to share research results to healthcare purposes.
- 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.
- Provide clear guidelines for data holders on what is required of them as data holders.
Rubén Ortiz, Delegate for Data Protection at the UB, has taken part in the creation of the LERU statement.