Digital Omnibus: Preserving patient agency and rights
The European Patients' Forum (EPF) calls for the Digital Omnibus proposal to preserve patients' rights, protect sensitive health data and maintain strong safeguards for digital healthcare.
In a new statement, EPF raises concerns that proposed changes to the General Data Protection Regulation (GDPR) could weaken health data protection and create uncertainty about how existing safeguards apply. Changes to the definition of personal data and the treatment of pseudonymised data require careful assessment, particularly given their potential implications for the European Health Data Space (EHDS).
EPF also stresses the need to preserve patients' agency when automated systems influence decisions about their care or access to services. Patients should receive clear information and understandable explanations, with access to human review and the ability to challenge decisions. These safeguards are particularly important for people living with chronic conditions, whose needs may not be fully captured by clinical data.
Simplifying EU digital rules must account for the particular sensitivity of health data. EPF calls on EU policymakers to carefully assess the proposal's impact on patients, maintain the balanced approach offered by the EHDS and give patient organisations sufficient time and opportunities to contribute. Investment in digital literacy and patient organisations' capacity is also essential to building trust.