The healthcare system is entering a new phase with digitization projects, leading to a paradigm shift in data protection. Pseudonymized patient data will be available for research unless the patient opts out. The European Parliament is set to release a voting proposal for the European Health Data Space (EHDS), while the Federal Minister of Health in Germany plans to introduce opt-out for the electronic patient file (EHR). Experts are divided on the matter, but many support the decision to introduce opt-out, subject to certain security precautions and a comprehensive right of objection for patients.
However, not everyone agrees. EDRI, a European civil rights organization, considers the decision to opt-out to be too overwhelming for patients and demands that health data not involved in the immediate treatment of the patient stay voluntary. Meanwhile, in opinion with Patrick Breyer, MEP for the Pirate Party, patients should be asked for consent before disclosing their medical data for any other purposes.
Informed consent for patients can be difficult, especially in emergencies when patients cannot provide consent. Consent is also complex for research institutions, leading some experts to call for a fair balance between user interests. The GDPR offers a strong research privilege; researchers must ensure suitable guarantees for those affected by collecting only pseudonymized patient data and informing patients about data usage.
