Protecting patients’ personal data is essential to maintaining confidentiality, professional secrecy and trust in healthcare. While digitalisation and AI can offer important benefits, including safer medicines use, more accessible services and innovation, simplification of EU digital rules must not come at the expense of the strong safeguards that apply to health-related data. This includes not only information explicitly identified as health data, but also information that can be inferred from searches, purchases, online consultations, pharmacy interactions, apps, wearables and connected services.

Weakening these protections could expose patients to new forms of tracking, profiling and commercial exploitation. The use of health-related data in AI systems must remain subject to a clear legal basis, necessity and proportionality, while pseudonymised health data should not automatically be treated as anonymous. Patients should also retain meaningful human oversight where automated systems may affect access to, recommendation, pricing or marketing of medicines and pharmacy services.

AIM, BEUC, CED, CPME, EFN, EAHP, EPF, HOPE and PGEU therefore call on EU co-legislators to ensure that the Digital Omnibus preserves strong protections for personal and health data, prevents their misuse for profiling or unrelated commercial purposes and safeguards patients’ rights in the development and use of AI. Digital innovation should support better healthcare and patient safety without weakening privacy, confidentiality or the trust on which healthcare depends.