With the launch of the European Health Data Space (EHDS), Europe's life sciences sector is facing a paradigm shift. For some, this means new opportunities; for others, increased demands and complexity. But for everyone, it means change.
EHDS is the EU's initiative to create a common digital structure for how health data is used and shared within Europe. The aim is to strengthen individuals' control over their data while enabling cross-border healthcare and research. The EHDS will make it easier to use data in both healthcare and innovation, but it also places new demands on interoperability, security, and responsibility for all actors in the health ecosystem.
"EHDS will not store health data, but it will control how you can use it. Whether you are developing AI in diagnostics, evaluating clinical performance, or working with post-market surveillance, data will be both an asset and a strategic challenge," says Henrik Fält Padoan, expert consultant at Plantvision.
Secondary use: an untapped asset
One of the most revolutionary changes brought about by the EHDS is the possibility of so-called secondary use of health data. This involves enabling access to anonymized data sets for research, innovation, and policy development in a harmonized and cross-border manner.
“For many companies, this could be absolutely crucial,” says Henrik. “EHDS provides access to data that was previously scattered, fragmented, or impossible to obtain, especially for rare diseases or underrepresented groups.”
This opens new doors for AI training, robust clinical studies, and effective post-market surveillance. But as always, with great opportunities come new requirements.
Interoperability, not just technology, but strategy
The regulation is based on interoperability, both technically and organizationally. Medical record systems and health documentation systems must support common standards such as the European Electronic Health Record exchange Format, EHRxF, in order to communicate seamlessly across borders and systems.
“This isn’t just a technical challenge,” explains Henrik. “It’s a shift in how we understand our role in the European health data ecosystem. The EHDS affects everything from product design to data management and legal issues.”
At the same time, the EHDS requires data controllers, data processors, and system providers to maintain the highest level of data security, transparency, and compliance.
An ecosystem in transition, and we can influence it
With Sweden's digital maturity and strong involvement in the design of the EHDS, life science companies in Sweden have the opportunity to influence the development of EU standards through, among other things, the eHealth Authority and the TEHDAS project. This is an opportunity we encourage our customers to take advantage of.
“Get involved early on. Build relationships, participate in consultations, and ensure that your needs are visible in the design of the new landscape,” urges Henrik.
So what do you need to do right now?
It is essentially a matter of gaining an overview, building structures, and beginning to adapt operations step by step. Start by reviewing your regulatory strategies: how does EHDS interact with MDR, the AI Regulation, and GDPR in your products? Then conduct a data inventory: what health data do you have, where is it stored, in what format, and do you have sufficient metadata?
The next step is to secure what is business-critical, identify risks of involuntary exposure, and create a sustainable confidentiality strategy. At the same time, you need to prepare technically: follow developments in interoperability requirements, ensure documentation, and have a plan for testing in national test environments.
To illustrate what this could mean in practice, Henrik describes a fictional example: a manufacturer of an advanced medical scanner. Today, it is both technically and legally difficult to integrate the product with medical record systems and to access the right data. But in a future EHDS landscape, it will be possible to connect directly to European medical record systems, retrieve data in standardized formats, and apply for access to broad, anonymized datasets. This will provide new opportunities to train AI algorithms, monitor clinical performance, and further develop the product in a data-driven way.
“With the right strategy, EHDS can be a catalyst for innovation,” says Henrik. “But it requires planning, courage, and new skills.”
Summary
The EHDS marks the beginning of a new chapter in how we understand and use health data in Europe. The regulatory framework is ambitious, challenging existing structures, but at the same time opening up a more cohesive, transparent, and data-driven ecosystem. For those working in life sciences, this means not only new requirements, but also an opportunity to rethink, innovate, and perhaps even think bigger. Understanding the EHDS is therefore not just about avoiding regulatory violations, but about seeing the direction in which the entire industry is moving. And choosing to be part of shaping it.
