A unified market for digital health solutions

The European Health Data Space (EEDS) paves the way for a single market for interoperable electronic medical records (EMRs), medical devices (MDs) and artificial intelligence systems (AISs). This harmonization will enable manufacturers complying with the regulation's requirements to market their solutions throughout the EU without additional regulatory hurdles.

Interoperability and traceability requirements

Compliance with harmonized standards is crucial, with particular emphasis on:

• Interoperability for smooth exchange of health data
• Strict logging of EMR access

Easier access to data for research

The regulation aims to boost health research by facilitating access to data. Data holders will be required to make their data available within a harmonized framework, opening up new opportunities for researchers.

Obligations and controls

Data holders will have to:

• Comply with obligations to make data available
• Submit to control by the bodies responsible for data access

Compensation and protection

In return, manufacturers will be able to:

• Collect royalties to cover the costs of making data available
• Benefit from guarantees for their business secrets and intellectual property rights

A balance to be struck

The EEDS marks a decisive step towards better exploitation of healthcare data on a European scale. For manufacturers, it opens up prospects for growth and simplified market access, but in return imposes a compliance effort.