Access to health data is a crucial aspect of healthcare research and policy development throughout Europe. While there are local differences in the access procedures and legal frameworks, there are also important similarities that govern the availability and use of health registries.
Data Governance and Access Procedures
In Europe, the availability of health data is facilitated through well-defined data governance and access procedures. These procedures aim to ensure controlled and efficient access to data, images, and body materials for research purposes. While there are no specific access procedures defined for health registries in some countries, general resources and guidelines, provide an overview of the processes and steps required for data access.
Legal Framework
Health registries in Europe must comply with the European General Data Protection Regulation (GDPR) as they collect personal data, including sensitive information like genetic and health data. The GDPR sets the standards for data protection and privacy across the European Union. Additionally, individual countries may have their own adaptations and implementations of the GDPR.
The proper implementation and compliance with data protection regulations are supervised by national authorities. These authorities ensure that the processing of personal data, including health data, is done in accordance with the GDPR and national regulations.
Codes of Conduct
In addition to specific legislation, there are codes of conduct that guide the responsible use of health data in registries. The Human Tissue and Medical Research Code of Conduct and the Code of Conduct for the Use of Data in Health Research provide guidelines and principles for researchers and organizations working with health registries. These codes emphasize the ethical and responsible handling of data.
Consent Methods
Countries in Europe adopt different methods to regulate patients’ consent for accessing health data. The opt-in method requires written permission from the patient to include their data in a registry. Variations of this method include specific consent for different research uses or dynamic consent, allowing patients to continuously determine the uses of their data. The opt-out method, commonly used in the Netherlands, allows patients to object and request the removal of their data from the registry.
