Seamless Integration
The EHDS regulation recognizes AI’s potential impact on electronic health data exchange and interoperability. By emphasizing compliance with interoperability standards and consultation processes, the regulation aims to promote the secure and efficient integration of AI in the health care data landscape. Dedicated AI systems for diagnostic support will be much more practical and successful when they are integrated with EHR systems, supporting the various steps in the delivery of patient care. Without such integration, the chances of successful adoption of a dedicated AI system at scale will be slim. The European EHRxF enables the seamless invocation of dedicated AI systems by an EHR system (providing the AI system with the personal electronic health data of the individual patient) and the direct integration of the results of applying AI to individual patient data in the EHR system. The AI Act and the EHDS regulation and MDR will of course need to be interpreted and used in articulation.