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New E-tool Sheds Light on the European Health Data Space (EHDS) Regulation

22nd May 2025

As artificial intelligence reshapes healthcare, clear and practical guidance on the use of health data is ever more crucial. While the new regulation on the European Health Data Space (EHDS) provides for a transition period of four to six years for most provisions, now it is the time for all parties – from the providers of Electronic Health Record (EHR) systems to those interested in the secondary use of health data – to prepare for fully capitalising the opportunities of the data space.

Building on the success of the AI Act e-tool and the Data Act e-tool, our Finnish-Danish joint action released the Entries EHDS Regulation e-tool. This new tool helps EHR system manufacturers, wellness app developers, medical device and IVD companies as well as high-risk AI system providers understand quickly what it takes to comply and benefit from the EHDS requirements. Likewise, the tool also supports health data holders and users aiming to deliver data-driven healthcare for the European citizens.

Like its predecessors, the EHDS e-tool is available free of charge to all SMEs and public organisations in the EU and Ukraine through the network of the European Digital Innovation Hubs (EDIHs) until the end of March 2026. 

We also collect feedback on all three Entries e-tools. This questionnaire runs in parallel to capture every users’ opinion and remarks on the e-tools. The sooner we have your feedback, the better we’re able to align with ongoing international and AI related initiatives for your advantage.

Find out more about the joint action from the project website of The Finnish Innovation Fund Sitra and join this Sitra webinar broadcast from Brussels 27 May 2025: The AI-driven future of the EU – transforming compliance with regulatory technologies.

 

HOW TO ACCESS THE EHDS REGULATION E-TOOL?

Please find the instructions to subscribe from here.

For further information, please contact any of the steering committee member of the joint action:

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Posted by Heikki Pitkänen

Heikki Pitkänen
Heikki is backed up with over two decades of experience from the Medical Device industry, including Notified Bodies, Certification Body Test Laboratories (CBTL) and international standardization. He is passionate about modern startup, business model and service design concepts and believes in collaboration among knowledgeable parties to efficiently support innovation.
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