The EHDS: A New Era for Health Data—Exciting and Scary

A seismic shift is coming to the European healthcare landscape. The European Health Data Space (EHDS), which entered into force in March 2025, is set to dismantle the data silos that have long characterized the industry. Its core mission is to create a single market for health data, enabling seamless access and exchange across borders for both patient care (primary use) and, more transformatively, for research, innovation, and policy-making (secondary use).

This is both an exciting and a scary proposition. On one hand, the EHDS promises to fuel a new generation of medical innovation, especially when combined with the regulatory framework of the EU AI Act. On the other, it represents a fundamental threat to the established order, forcing the "owners" of vast, proprietary patient data troves—legacy medical device manufacturers and life sciences companies—to share their crown jewels. This article unpacks the dual nature of the EHDS: its incredible opportunities and the significant dangers it presents.

What is the EHDS and Secondary Use?

The European Health Data Space (EHDS) is a health-specific ecosystem comprised of rules, common standards, and infrastructures. Its goal is twofold:

1. Primary Use: To empower patients by giving them immediate, easy access to their electronic health data in a common European format, which they can share with healthcare professionals across the EU.
2. Secondary Use: To create a trustworthy framework for researchers, innovators, and public institutions to securely access high-quality health data for purposes like scientific research, developing new treatments, training AI algorithms, and informing public health policy.

The concept of **secondary use** is the revolutionary—and controversial—heart of the EHDS. It mandates that "data holders" (hospitals, research institutions, and private companies) must make certain categories of health data available to approved "data users" upon request. This will be managed through national Health Data Access Bodies (HDABs), which will grant permits for data access in a secure, controlled environment.

The Interplay: EHDS, GDPR, and the EU AI Act

The EHDS does not exist in a vacuum. It is designed to work in concert with two other landmark EU regulations:

• GDPR (General Data Protection Regulation): The EHDS builds upon the GDPR, reinforcing patient rights. While GDPR provides the foundational principles for data protection, the EHDS creates specific rules for health data. It enhances patient control with a clear opt-out mechanism for secondary use and mandates that data must be processed in a secure environment, using anonymization or pseudonymization techniques to protect privacy.
• EU AI Act: The EHDS is the fuel for the AI Act's engine in the healthcare sector. The AI Act sets rules for developing and deploying artificial intelligence, especially "high-risk" systems like those used in medical diagnostics. To build unbiased and effective AI, developers need vast amounts of high-quality, diverse data. The EHDS is designed to provide exactly that, creating a legal and practical pathway to access the data needed to train, test, and validate AI models under the AI Act's stringent requirements.

The Timeline: A Staggered Rollout

The EHDS will not be switched on overnight. The implementation is phased over several years to allow for the creation of the necessary technical and legal infrastructure:

• March 2025: The EHDS Regulation enters into force, starting the transition period.
• March 2027: Deadline for the European Commission to adopt key implementing acts with detailed operational rules.
• March 2029: Key obligations for the **secondary use** of health data come into effect for initial data categories.
• March 2031: Secondary use rules expand to include more complex data categories, such as genomic data.

The Opportunity: A Golden Age for Health Innovation

The democratization of health data access under the EHDS will unlock unprecedented opportunities:

• Accelerated Research: Researchers will be able to study diseases, treatment efficacy, and health trends on a massive, pan-European scale, dramatically speeding up discoveries, especially for rare diseases.
• A Boost for AI and Startups: Startups and innovators in the AI space will gain access to the high-quality data they need to compete globally. This will level the playing field, fostering a new ecosystem of AI-driven diagnostics, personalized medicine, and predictive health solutions.
• Better Public Health Policy: Policymakers will be able to make more informed, evidence-based decisions to improve healthcare systems and respond to public health crises.

The Resistance and Dangers: A Threat to the Old Guard

For every opportunity, there is a corresponding threat, and legacy MedTech and life sciences companies are right to be concerned. For decades, their market position has been fortified by proprietary datasets curated through years of clinical trials and product use. The EHDS challenges this model directly.

The primary points of resistance and fear are:

• Intellectual Property (IP) and Trade Secrets: The biggest fear is that being forced to share data will lead to the disclosure of valuable IP and trade secrets embedded within those datasets. While the EHDS regulation requires HDABs to take measures to protect IP, the industry remains skeptical about how effective this will be in practice, fearing that competitors could reverse-engineer products or gain insights into R&D strategies.
• Endangerment of Market Position: By giving startups and smaller innovators access to the same scale of data, the EHDS erodes a key competitive advantage of large, established players. They risk losing their data-driven edge, forcing them to compete on a more level playing field where agility and innovation may matter more than historical data ownership.
• Implementation and Fragmentation Concerns: There are significant worries about the practical implementation. The patient opt-out mechanism, while essential for trust, could lead to fragmented and biased datasets if managed differently across Member States. Furthermore, the cost and technical complexity of preparing and sharing data in a compliant manner present a substantial operational burden.

Navigating the New World

The European Health Data Space is an audacious, complex, and transformative initiative. It represents a fundamental rewiring of how health data is valued and utilized in Europe. For innovators and AI pioneers, it is a starting pistol for a new race. For established giants, it is a disruptive force that demands immediate strategic re-evaluation.

Success in this new era will not be about hoarding data, but about being able to use it intelligently, ethically, and strategically. Whether you see the EHDS as a golden opportunity or a looming threat, one thing is certain: ignoring it is not an option.