Of Counsel @ SLB - EDPB's Support Pool of Legal Experts - Fellow Istituto Italiano Privacy - Maestro della Protezione Dati & Data Protection Designer® IIP
Importante nuovo passo in avanti rappresentato dall'adozione dell'#European #Health #Data #Space, generatore di una auspicata riorganizzazione dei sistemi sanitari
The European Parliament has just adopted the European Health Data Space (EHDS) regulation, marking a historical moment for digital health in the EU. This monumental step will have a profound impact on the rights of natural persons to their electronic health data and on the possibilities for the reuse of such data. The EHDS will empower individuals to access their electronic health data through patient portals or apps. This is aligned with the goals of the Digital Decade policy programme 2030: 100 % citizens having access to their electronic health records. Furthermore, the regulation will ensure that electronic health data follows patients when they seek care from different healthcare providers within their own Member State or across the EU. Through the European electronic health record exchange format, the regulation will promote further harmonisation of structures in data exchanged by electronic health record systems. In addition to structured data, the format should also support the exchange of unstructured clinical documents, to ensure the implementation of the rights of natural persons. The electronic health record systems will be certified to guarantee their compliance with interoperability and logging requirements. To ensure secure access to electronic health data for secondary use purposes, the regulation will establish a network of health data access bodies in each Member State. This will accelerate research and innovation in the EU, contributing to the development of new treatments and advanced health solutions. Two key infrastructures, MyHealth@EU and HealthData@EU, will be established to support the implementation of the EHDS. While the creation of these infrastructures is a significant undertaking, progress is well underway. The main components of MyHealth@EU are already operational, and pilots are ongoing in HealthData@EU. The European Health Data Space regulation signifies a major leap forward, enabling seamless flow of health data for the benefit of all of us.
