EHDS Q&A: Understanding the basics – Part 2
Part 2 of our EHDS Q&A focuses on readiness and implementation, detailing the infrastructure, governance, and changes needed to be ready on time.
EHDS Q&A: Understanding the basics – Part 1
Part 1 of 2: What’s the urgency?
As the European Health Data Space come online, non-compliance may result in fines up to €10 million or 2% of organizations’ worldwide turnover. By March 2029, most regulations will come into force.
Don’t let this lead time fool you—a lot needs to be done to make your data available, and it’s easy to fall behind.
When the time comes, your organization will be asked to make its data open for querying and access. You’ll have just three months from the date you receive this request to make the data available, or risk daily penalties.
The European Health Data Space (EHDS) is an ambitious EU-wide initiative to advance digital health by protecting and streamlining electronic health data for all Member States. It sets common standards to get health data to where it’s needed, quickly and securely. The related HealthData@EU platform provides a huge opportunity for researchers and innovators to accelerate real-world breakthroughs with its controlled access to anonymized health data. In March 2029, most health data rules that apply to research (secondary use) will kick in. That gives European university hospitals and other healthcare institutions roughly three years to get their EHDS basics in order. This is a huge task for almost any institution, but especially where analogue (i.e. non-digital) records are in use or were used until recently.
By March 2031, the EHDS will be fully up and running, and researchers from around the world will be able to join HealthData@EU and request access to EU health data.
Given the scale of this initiative, all EU-based organizations have a serious responsibility to be ready when it goes live.
EHDS compliance is a significant undertaking—is your organization ready?
In fact, recent market research suggests that only 31% of EU hospitals are EHDS-compliant, while just 17% of providers can deliver anonymized EHDS-ready datasets for research and AI training.
The deadline is approaching sooner than you might think!
What happens if my organization is non-compliant?
Key to making the EHDS a success will be to demonstrate that the system can be trusted. This means that patients, healthcare providers, researchers, and innovators can be assured that electronic health data is accessible and secure wherever they may be.
This is why all organizations need to pay attention to the upcoming deadlines. If you haven’t made your changes by the time the rules come into force, you run the risk of being fined. These penalties are there to make sure that the rollout of the EHDS is smooth and that everyone aligns with the new rules.
Keeping organizations on track falls to national bodies known as Health Data Access Bodies (HDABs) that are in charge of enforcing the rules. These bodies will be asking health data holders to provide their data when the time comes.
The rules are strictly enforced, and organizations will have just three months to deliver data in response to a request, leaving no room for delays or surprises.
Should your organization miss a deadline, HDABs can impose a penalty for each day the data is overdue and designed to get your attention and drive action. The rules follow core fundamental principles of effectiveness, proportionality, and deterrence—signaling that delays won’t be taken lightly.
Just how bad are these fines, you say? Non-compliance is no small matter and can result in your organization being fined up to €10 million or 2% of worldwide turnover, whichever is higher. Refusal to comply will up the ante to €20 million or 4% of turnover, whichever is higher. Detailed enforcement guidelines are set to be released by the EU Commission on 26 March 2027. That’s why you need to take your EHDS obligations seriously long before enforcement kicks in.
What and when are the major EHDS milestones?
EHDS got the green light in March 2025, marking the beginning of a significant, EU-wide transition period.
- March 2027: The EU Commission will have adopted several ‘key implementing acts’. These will provide detailed operational rules, including technical specifications
- Member States will also designate their HDABs
- March 2029: Major sections of the EHDS Regulations will begin to apply across all Member States:
- Primary use: The first group of priority data categories (patient summaries, ePrescriptions/eDispensations)
- Secondary use: Most data categories
- March 2031: The remaining parts of the EHDS Regulation come into force
- Primary use: The second wave of priority categories (medical images, lab results, hospital discharge reports)
- Secondary use: Remaining data categories such as genetic data
- March 2034: Health data secondary use will be made available to non-EU countries and international organizations that apply to join HealthData@EU.
BC Platforms offers a trusted research environment that is ready for EHDS regulations. The one-stop flexible and scalable solution centralizes multi-modal data management, empowers intuitive cohort discovery and planning, and accelerates advanced analytics with robust governance and AI-powered tools.
BC Platforms offers a trusted research environment that is ready for EHDS regulations. The one-stop flexible and scalable solution centralizes multi-modal data management, empowers intuitive cohort discovery and planning, and accelerates advanced analytics with robust governance and AI-powered tools.
Contact our team today.
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