European Union Approves European Health Data Space (EHDS) Regulation

The European Union has taken a significant step towards the digitisation and interoperability of health data with the adoption of Regulation (EU) 2025/327, which establishes the European Health Data Space (EHDS). The aim is to facilitate the secure sharing of health data, ensure that citizens have greater control over their electronic health information, and boost research and innovation in the digital health sector.

The regulation defines two main types of data use:

• Primary use: citizens' access to and control over their electronic health records (EHRs), enabling the secure sharing of data between healthcare professionals, regardless of the EU country where they are receiving care.

• Secondary use: reuse of health data for research, innovation, public policy development and regulation, while ensuring the privacy and protection of citizens.

To enable this interoperability between national systems, the regulation establishes the MyHealth@EU platform, which will act as a digital contact point between Member States, facilitating the cross-border exchange of health information.

Impact on the Medical Devices and Digital Health Sector

The regulation imposes new requirements on manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) that claim interoperability with Electronic Health Records (EHRs). These devices must demonstrate compliance with specific requirements for interoperability, security, and data traceability.

In addition:

• If a product is both an EHR and a medical device, it must comply with both regulations, including the requirement to register with EUDAMED.

• Digital wellbeing applications that claim interoperability with EHRs must be accompanied by a label of compliance with the common specifications defined by the EHDS.

Deadlines and Next Steps

The regulation will enter into force 20 days after its official publication, and the first obligations will become applicable from March 2027. For manufacturers of medical devices and digital health solutions, it is essential to closely monitor the new requirements and adjust their products to ensure regulatory compliance and access to the European market.

The European Commission has also published an official FAQ on the EHDS to clarify questions from stakeholders, which can be found below.