The second report of the Joint Action Towards the European Health Data Space (TEHDAS) examines potential options for governing the exchange and wider use of health data between European countries. The secondary use of health data means using such data for secondary purposes. Governance refers to the rules and legislative framework set to protect health data.
The first TEHDAS report concluded that the unique specificities of health data compared to data in many other sectors require specific EU legislation(open in new window) to regulate its cross-border use and exchange. This second document shows that the multiple actors currently governing different types of data serve their specific purpose but cannot support with their current mandate – neither the creation of a single market for health data nor wider use of health data for research, innovation and decision making.
Currently, there are different approaches to the access, sharing, and the use of health data in the member states. Diverging and often conflicting national laws impede access to data in a cross-border setting and hinder digital health progress and free movement of EU citizens.
TEHDAS also identified most common barriers for sharing health data(open in new window). For instance, individuals cannot transfer freely their personal data across the member states which effects their rights to seek cross-border healthcare.
The European Commission’s upcoming legislative proposal of the European Health Data Space will form the legal basis for data use, facilitating data mobility.
The actors studied were Eurostat(open in new window), European Medicines Agency(open in new window), European Centre of Disease Prevention and Control(open in new window), the eHealth Network(open in new window), European Reference Networks(open in new window), and 1+ Million Genomes Initiative(open in new window) which are all existing structures. Additionally, the document analysed the European Data Innovation Board proposed in the Data Governance Act(open in new window) and Health Technology Assessment(open in new window), forthcoming regulation that benefits patients’ access to medicinal products and devices.
Bron: TEHDAS
EU should rethink policies on health data access
- Gegevens
The EU aims to create a single health data market, but the current structure of the Union is unable to fully support the extensive use of such data across the member states.
