Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data Act e-tool, the Finnish-Danish joint action has released an invaluable e-tool that sheds light on the European Health Data Space (EHDS) regulation.
The Entries EHDS Regulation e-tool is a free resource to support SMEs and public organizations in Europe, through the network of the European Digital Innovation Hubs (EDIHs), until the end of March 2026.
What is Lean Entries?
Lean Entries is the digital sandbox within its parent company Aurevia that transforms complex regulatory requirements into actionable knowledge. With over 20 years of experience in QA/RA, Heikki Pitkänen, CEO of Lean Entries and Senior Expert, Regulations & Quality at Aurevia, has helped hundreds of healthtech innovators — from medtech startups to AI developers — turn regulations into opportunity.
Read the full article to learn how our e-tool sheds light on the EHDS Regulation.
Need urgent support?
At Aurevia, Heikki and our team of ca 100 experts in quality assurance, regulatory affairs and clinical research are here to support you with tailored guidance and hands-on expertise. Let’s discuss how we can help you transform regulatory complexity into strategic clarity so your organization can move ahead quickly to achieve your goals.
Contact us so we can discuss your specific needs.
BREAKING