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

Area of Science:

• Health Informatics
• Medical Research
• Data Science

Background:

• Electronic Health Records (EHRs) are vital for medical research, but data collection faces challenges.
• Patient data donation is increasingly important, especially within the European Health Data Space (EHDS).
• Current methods struggle with subject recruitment and data quality for secondary data use.

Purpose of the Study:

• To propose a scalable, open architecture for collecting real-world data from EHRs for secondary use.
• To facilitate efficient and secure access to valuable health information for research purposes.
• To support the goals of the European Health Data Space (EHDS) framework.

Main Methods:

• Assessed current EHR technologies, operational readiness, and interoperability standards in the EU.
• Conducted a literature search to identify related work and inform the architecture design.
• Developed an open architecture based on established interoperability standards.

Main Results:

• An open architecture integrating IHE and FHIR interoperability standards is proposed.
• The architecture is designed for seamless integration into existing, standards-based EHR systems.
• It incorporates mechanisms for managing patient consent and data privacy zones.

Conclusions:

• The proposed architecture offers a scalable solution for secondary use of EHR data.
• It enhances data accessibility for research while respecting patient privacy and consent.
• This framework supports the advancement of personalized medicine and public health initiatives.