European Commission Publishes FAQs on European Health Data Space (EHDS)

The European Commission has recently released a set of Frequently Asked Questions (FAQs) regarding the European Health Data Space (EHDS). The EHDS proposal aims to establish a framework for sharing health-specific data, promoting data sharing, innovation, research, and policy making in the healthcare sector across the European Union.

The EHDS aims to create a health-specific data sharing framework that includes clear rules, common standards, digital infrastructures, and governance practices for the use of electronic health data by patients, healthcare professionals, researchers, policymakers, and industry stakeholders.

Summary of FAQs

1. Empowering Individuals: The EHDS aims to empower individuals across the EU by giving them more control over their health data, enabling easier access and sharing while maintaining greater control.
2. Facilitating Healthcare Professionals: Health professionals will benefit from improved interoperability, allowing access to patients’ medical history across borders for informed treatment and diagnosis decisions.
3. Enabling Research and Innovation: Researchers will have access to larger amounts of high-quality data in a secure framework, enhancing research, innovation, and development of new healthcare solutions.
4. Informing Policy Making: Regulators and policymakers will have easier access to health data for evidence-based policy making, leading to better healthcare access, reduced costs, and increased efficiency.
5. Boosting Industry Opportunities: Industry will benefit from an EU-wide market for electronic health record systems, fostering innovation in healthcare products and devices, including those utilizing artificial intelligence technology.
6. Enhancing Data Governance: The EHDS introduces a governance framework at national and EU levels, establishing rules for primary and secondary use of health data, with a focus on data privacy and security.
7. Financial Support: The EHDS is expected to save the EU around €11 billion over ten years, with funding coming from various sources including EU funds, Member States’ investments, and Commission support.
8. Alignment with Other Health Initiatives: The EHDS is a central component of a strong European Health Union, supporting initiatives such as Europe’s Beating Cancer Plan, Pharmaceutical Strategy for Europe, and the Health Emergency Response Authority (HERA).
9. Data Privacy and Security: The EHDS complies with existing data protection regulations and introduces additional security criteria to ensure secure data processing and prevent misuse of sensitive health data.
10. Preparation of Member States: Member States are at various stages of digital health maturity but are preparing for the EHDS by enhancing digitalization and interoperability within their healthcare systems.