Navigating the European Health Data Space: What the New EHR Requirements Mean for Manufacturers
- Jun 23
- 2 min read
The European Health Data Space (EHDS) is transforming the way health data is managed and shared across Europe. As the new regulatory framework takes shape, understanding its implications for Electronic Health Record (EHR) systems has become increasingly important for developers, manufacturers and digital health innovators.
Marta Wilińska and Magdalena Kogut from Timelex, AI4LUNGS’ legal partner, have published a comprehensive legal analysis exploring the new requirements introduced under the EHDS Regulation, which entered into force in May 2025.
The article explains why dedicated regulation for EHR systems is needed to improve interoperability across the EU and examines how the new framework aims to support the secure exchange of electronic health data while reducing fragmentation between healthcare systems.
If you want to know more about
What qualifies as an EHR system under the EHDS Regulation
The new interoperability and logging requirements
Manufacturers' obligations before placing EHR systems on the EU market
The relationship between the EHDS, the Medical Devices Regulation (MDR), the AI Act and other EU legislation
As AI-driven healthcare solutions continue to evolve, understanding the regulatory landscape is essential to ensuring that innovation goes hand in hand with compliance, interoperability and patient trust.
“Manufacturers should assess, already at an early stage of product design, whether their solutions qualify as EHR systems under the EHDS and align their architecture, technical documentation, and compliance with interoperability, security, and logging requirements accordingly, while closely monitoring the European Commission's forthcoming implementing acts that will further specify these obligations. “- legal consultant, Marta Wilinska.
For organisations developing digital health technologies, early preparation will be crucial as technical specifications and implementing acts continue to emerge over the coming years.
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