European health and consumer groups call for patient data safeguards in Digital Omnibus
European health and consumer organisations urge EU lawmakers to protect sensitive patient data while supporting responsible digital innovation.
Nine European organisations representing healthcare professionals, patients and consumers have issued a joint statement urging EU lawmakers not to weaken protections for patient data as part of the Digital Omnibus.
The organisations acknowledge that digitalisation can deliver “better healthcare, safer medicines use, innovation and more accessible services”, but they warn that efforts to simplify EU digital rules must not come at the expense of “patient confidentiality, professional secrecy or trust in healthcare”.
At the heart of their concerns is the growing range of information that can reveal someone’s health status. This extends beyond medical records to online searches, purchases, consultations, pharmacy interactions, health websites, wearables and apps.
The statement calls for continued strong protection of health and inferred health data, including when data are used in AI systems. It also urges lawmakers to prevent health information being reused for “profiling, advertising, commercial targeting or unrelated commercial purposes”.
The organisations say that attention is needed to ensure that pseudonymized health data remains anonymous. There have been recent cases where such information may still be linked back to individuals when combined with other datasets, or analysed using advanced techniques.
Automated decision-making is another key concern. Where decisions could significantly affect patients, the statement calls for “meaningful human oversight” alongside clear explanations and support from healthcare professionals.
The signatories support simplifying requirements that do not contribute to patient safety, but argue that innovation in healthcare must be built on trust. They urge EU lawmakers to preserve strong safeguards as Europe’s healthcare sector becomes increasingly digital.
Signatories: International Association of Mutual Benefit Societies (AIM); The European Consumer Organisation (BEUC); Council of European Dentists (CED); Standing Committee of European Doctors (CPME); European Federation of Nurses Associations (EFN); European Association of Hospital Pharmacists (EAHP); European Patients’ Forum (EPF); European Hospital and Healthcare Federation (HOPE); and Pharmaceutical Group of the European Union (PGEU).