BRUSSELS– 24 April 2024 – The European Parliament approved the political agreement on the European Health Data Space (EHDS) Regulation.
The published outcome contains the following elements:
- EU Member States may require data localization for primary uses;
- EU Member States may restrict personal data transfers in accordance with Art. 9(4) of the General Data Protection Regulation (GDPR);
- Health Data Access Bodies must localize data in certain processing scenarios, except in relation to third countries that are covered by an adequacy decision under Article 45 of the GDPR; and
- Transfers to third countries will be restricted if the third country does not provide “reciprocal” access to health data to the EU.
The GDA remains highly concerned regarding the implications of these cross-border data restrictions for healthcare research, development, and delivery – as well as the impact on patients – in the EU and beyond. The degree of disruption implied by these restrictions will depend, to some extent, upon their implementation, and the GDA is committed to working with EU authorities to avoid unnecessary restrictions and to find ways to ameliorate their impacts.
As reflected in the GDA’s recent comments, cross-border data transfers play a critical role in advancing healthcare research and development (R&D), the management of healthcare services and products, and the search for new treatments and healthcare solutions to address emergent health challenges. Without the ability to transfer data internationally, in a manner consistent with GDPR, the ability to conduct such R&D as well as to identify and develop new treatments and healthcare solutions may be fundamentally compromised or, at the very least, undermined. As explained by public health authorities and private research organizations, the ability to transfer and access knowledge, information, and data across transnational digital networks is integral to efforts aimed at meeting global and regional health challenges.