The European Commission has presented a regulation to set up a European Health Data Space (EHDS). The Regulation sets out rules, common standards and practices, infrastructures and a governance framework that is key to the European Health Union.
For it to be successful, it is crucial that the EHDS ensures legal certainty and flexibility, and that it establishes open, transparent and structured engagement with all stakeholders. Moreover, the Commission must work towards fully linked EHR systems and sectoral standards for the collection and integration of patient-led data, while leveraging existing global and European Union standards and certifications. This includes taking the appropriate measures that ensure the interoperability of legal and operational requirements across organisational and geographical borders. Furthermore, international data flows for research and development purposes must be maintained, as it is key for global public health. For this, the Commission should limit hindrances on international data flows with third countries that could limit drug discovery and development.
