Data Saves Lives Shares Update on EHDS Regulation

We are sharing an important update regarding the European Health Data Space (EHDS) regulation, which is set to come into force in late March 2025. This regulation has the potential to empower patients across the European Union by providing access to their health data and harnessing its research potential. 

First what is it? 

Data Saves Lives is a project aimed at raising awareness about the importance of health data and helping people understand how it's used across Europe. Led by the European Patients’ Forum (EPF) and the European Institute for Innovation through Health Data (i~HD), it promotes responsible use and good practices for health data. The project highlights how health data can advance scientific research, improve healthcare systems, and benefit patients. 

The European Health Data Space (EHDS) is a set of rules designed to make sharing and using health data easier across EU countries. It aims to create a unified digital health system that supports better healthcare, research, and innovation while ensuring data privacy and security. The EHDS will give individuals control over their health data and help them access personalised healthcare services. 

So why do we need to know? 

The European Patients’ Forum (EPF) has released a detailed analysis of the EHDS regulation, highlighting the most relevant changes and obligations introduced, along with several recommendations for a successful and patient-centric implementation. 

As Ambassadors of the FH Europe Foundation, this development is particularly significant for us. The primary goal of the EHDS is to empower patients to access their health data and enable health professionals to consult patients’ medical records through Electronic Health Records (EHRs). This will allow citizens in the EU to access, manage, and share their health data electronically (primary use), and facilitate its use for public interest, policy making, and research (secondary use). 

For our community, the EHDS regulation represents a major step forward in improving the diagnosis, treatment, and management of familial hyperlipidaemias (FH) and related conditions. By ensuring that health data is accessible and usable, we can enhance patient care and support research initiatives that drive innovation in healthcare, but you need to know what it means for you. 

To ensure a successful enforcement of the regulation and mitigate any unintended consequences, EPF calls on Member States and the European Commission to prioritise the following key actions during the implementation period: 

• Accessibility and Usability: EHR (Electronic Health Records) systems must be user-friendly, with clear interfaces. 

• Transparency: Patients should have transparent information in lay language on how their health data is collected, stored, used, and protected within the EHDS framework. 

• Consent: It is crucial to provide patients with complete information on the opt-out mechanism from the re-use of health data for secondary purposes. 

• Digital Health Literacy: It is essential to continue promoting digital health literacy programmes, especially in underserved and rural communities. 

• Stakeholder Engagement: The EHDS stakeholder forum should function as a true advisory board, whose feedback and recommendations are actively incorporated and acted upon. 

• Financial Considerations: Addressing concerns about the financial burden on Member States and regions is crucial for sustainable implementation. 

• Security and Privacy: Ensuring state-of-the-art security measures to strengthen the protection and cybersecurity surrounding data storage and processing is of utmost importance. 

• Minimising Legal Uncertainty: It is critical to reduce legal uncertainties surrounding the implementation of EHDS. 

As Ambassadors, your role in advocating for these priorities is vital. By staying informed and engaged, we can collectively work towards a future where healthcare is more personalised, effective, and inclusive for all patients. 

Read more and access the full article on the Data Saves Lives website.