Fit for the EHDS? What digital health providers need to know now

Digital health solutions thrive on data - and this is precisely the focus of the European Health Data Space (EHDS). It is intended to ensure that health data is secure, usable and meaningfully networked throughout the EU. This opens up new opportunities for digital health companies, medical technology providers and healthcare institutions: better care, faster research and innovative business models.

But what exactly is behind the EHDS? What opportunities does it bring - and what do providers need to be prepared for? The most important questions and answers can be found in our FAQ.

The EHDS is a European Union initiative for the secure and cross-border use of electronic health data, both for medical care and for research and innovation. The regulation came into force on March 26, 2025. Since then, it has been implemented in stages:

In Germany, the implementation of the EHDS is currently in the preparatory phase. Legal and technical foundations are being laid in order to meet the requirements of the regulation and make the benefits of the EHDS usable.

While systems such as the electronic patient record (ePA) focus on individual care, the EHDS goes one step further: it also enables the secondary use of data. This includes data-supported research, innovation development and health policy-making at EU level. Uniform standards and EU-wide interoperability should enable the exchange of data across national borders.

Data protection has top priority. The EHDS is based on the General Data Protection Regulation (GDPR) and relies on strong technical and organizational protective measures. Any use of health data is subject to strict rules, for example via national data access points that monitor and coordinate access.

Medtech manufacturers and IoMT (Internet of Medical Things) providers will be able to better integrate their devices into interoperable data infrastructures in the future. This means that real-time data from wearables or sensors can be analyzed more easily and integrated into hospital and patient data sets. At the same time, the requirements for data protection, interfaces and data quality are increasing.

Companies that offer data-based products or services, for example in the fields of digital health, AI in diagnostics or health IT, have enormous potential. Those who focus on interoperability and GDPR compliance at an early stage can certainly secure competitive advantages.

While a number of projects are underway to implement the EHDS, three of them are currently playing a particularly central role:

• HDP4Germany is laying the foundations for data access in Germany. The aim is to create the necessary infrastructure so that health data can be shared and used securely and efficiently in the future - for example for research, healthcare or innovations in everyday clinical practice.
• HealthData@EU is building an EU-wide network that enables the secure and standardized exchange of health data across national borders. This will benefit not only patients, but also digital health providers who want to scale their solutions internationally.
• TEHDAS provides the conceptual and technical basis for the EHDS. The project develops guidelines and standards that provide orientation for companies and institutions, how systems can be designed to be interoperable and how data can be used in a legally compliant manner.

These projects show the EHDS is not just a political project, but is already being prepared in very concrete terms. It provides opportunities for those who want to use healthcare data sensibly.