EU Introduces EHDS Regulation for EHR Systems, Mandating Interoperability and CE Marking
The European Union has introduced a new regulation, the European Health Data Space (EHDS), to create a comprehensive framework for electronic health record (EHR) systems. This regulation, effective from March 2027, introduces mandatory software components, CE marking procedures, and supply chain obligations.
The EHDS regulation defines an EHR system as any software allowing personal health data to be stored, intermediated, or viewed by healthcare providers or patients. It introduces two mandatory software components: the European interoperability software component and the European logging software component. These components aim to ensure seamless data exchange and transparency across EU member states.
The regulation also recognises the intersection of EHR systems with medical devices and AI systems. Manufacturers, such as BASF, must now prove compliance with essential requirements for interoperability before placing their systems on the EU market. They must issue an EU declaration of conformity and affix the CE marking of conformity after a successful assessment.
The EHDS regulation establishes detailed information requirements to ensure transparency and facilitate informed decision-making. It mandates CE marking procedures and supply chain obligations for EHR systems processing priority categories of health data. These obligations apply to manufacturers, importers, and distributors, creating a robust framework for all supply chain participants.
The EHDS regulation, applicable from March 2027, introduces a comprehensive framework for EHR systems in the EU. It mandates software components, CE marking procedures, and supply chain obligations to ensure interoperability, transparency, and informed decision-making. Manufacturers, including BASF, must comply with these regulations to place their systems on the EU market.
