An Open Architecture for the Secondary Use of Real World Data from Large Interoperable Health Records.

Real-world data from Electronic Health Record (EHR) systems is crucial in medical research, particularly for understanding diseases, treatment efficiency, patient safety, personalized medicine, drug research, and public health surveillance. Despite its significance, collecting and utilizing this data for secondary use is challenging due to bottlenecks such as recruitment of study subjects and difficulties in linking high-quality data. The concept of data donation by patients is gaining importance also in the context of the European Health Data Space (EHDS) framework. The paper aims to propose a scalable, open architecture for collecting real-world data in EHRs for secondary use. Current EHR technologies, operational readiness and interoperability standards are assessed based on existing EHRs in the European Union. Using a literature search related work has been identified to derive an open architecture for collecting structured data for secondary used. An open architecture based on IHE and FHIR interoperability standards is proposed to integrate into existing, standard based EHR systems respecting consent requirements and data zones regarding privacy levels.