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EU should rethink policies on health data access

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.

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 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. 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, European Medicines Agency, European Centre of Disease Prevention and Control, the eHealth Network, European Reference Networks, and 1+ Million Genomes Initiative which are all existing structures. Additionally, the document analysed the European Data Innovation Board proposed in the Data Governance Act and Health Technology Assessment, forthcoming regulation that benefits patients’ access to medicinal products and devices.

The TEHDAS initiative will continue to engage in active dialogue with European institutions and stakeholders on the creation of the European Health Data Space. We will further examine the scope and model of the health data governance, which can range from health data collection to promoting data analytics and use of health data for innovations. A final concluding document will be published at the end of 2022.

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