This White Paper is your essential guide to understanding the EHDS Regulation, its ambitious goals, and the practical steps needed for compliance. Whether you’re a pharmaceutical company, healthcare provider, researcher, policymaker, or industry leader, you’ll need to know what’s coming.

Executive Summary

The European Health Data Space (EHDS) is an initiative by the European Union aimed at creating a unified framework for the secure and ethical reuse of electronic health data across the EU for research, innovation, and policy. The EHDS will benefit patients by providing easier access to their health records across borders and greater control over their data. Healthcare providers and patients will experience improved continuity of care, while researchers and the pharmaceutical industry will gain access to large-scale, high-quality health data. Policymakers and regulators will have a robust foundation for monitoring public health.

The EHDS distinguishes between EHDS1 for the primary use of health data (e.g., patient care) and EHDS2 for the secondary use of health data (e.g., research, innovation, policy making), with this document specifically focusing on the latter. The operation of EHDS2 involves three key stakeholders: Health Data Holders (HDHs), which are organisations that control electronic health data; Health Data Access Bodies (HDABs), which are public sector bodies managing data access for secondary use; and Health Data Users (HDUs), which are individuals or organisations granted access to electronic health data for secondary purposes. In addition to discussing the requirements for each stakeholder, this document highlights potential challenges and solutions they may face in implementing the EHDS2. Specifically:

• Health Data Holders should establish an internal cross-functional EHDS group to prepare their compliance. This could include people dealing with IT, legal, data entry, depending on the organisation. This team should help prepare to catalogue electronic health data assets and to evaluate their capacity and capability for data provision and other EHDS2 obligations.
• Health Data Access Bodies will require significant investment and staffing to operate. The main challenges include successfully establishing a National Catalogue of health data, evaluating health data applications, processing the health data, setting up a ‘secure processing environment’ (SPE) where the data can be accessed and analysed, and monitoring compliance and security. To succeed in their role, they need to ensure trust and compliance through stakeholder engagement from the outset.
• Health data applicants and users will need to carefully prepare their applications. This could include building sample analysis models and requesting pre-submission consultations with HDABs. To respect the 18-month deadline for publishing results, HDUs may need to plan their research accordingly and utilise the extension exceptions, if needed. The combined challenge for all EHDS2 stakeholders is to establish a health data network, which is useable and sustainable. There are examples of successful, and less successful, health data networks, although the scale of EHDS2 is significantly larger, lessons should be learned from these past experiences. We have taken these lessons to identify the challenges, provide you with directions on how to overcome these challenges and successfully implement your requirements.

Should you want to discuss implementing the EHDS, fill out the ‘contact us’ form on this page, we would love to hear from you.