In May 2022, the European Commission (EC) introduced the concept of a European Health Data Space (EHDS). This initiative aims to create a unified framework and infrastructure for utilizing health data for research, innovation, policy development, and regulatory practices across the European Union (EU). The EHDS will also establish common standards and protocols, allowing EU citizens greater access, control, and capability to share their electronic personal health data. As of April 2024, the European Parliament has approved the proposed EHDS Regulation, and the European Council is anticipated to follow suit, making way for the inaugural common EU data space to be operational by late 2024.
AWS’s Role in EHDS Implementation
At Amazon Web Services (AWS), we view the EHDS as a significant stride toward unlocking the immense potential of health data for the benefit of citizens in Europe and beyond. The EHDS positions Europe to take the lead globally in ethical and privacy-conscious approaches for health data utilization.
As the world’s most extensive and widely adopted cloud provider, we acknowledge our responsibility to assist customers in securely and responsibly leveraging health data. Our investments in developing capabilities and services tailored to the specific privacy and security needs of the healthcare sector further reinforce this commitment. We are also dedicated to supporting open-source, open-data, and open-standard initiatives.
Security remains our foremost priority at AWS. We have built our cloud computing environment to be the most secure available today, with infrastructure meeting the stringent security demands of sensitive industries like healthcare. AWS has achieved compliance with internationally recognized standards, being the first cloud provider to secure the Cloud Computing Compliance Controls Catalog (C5) attestation in Germany, along with the Hebergement de Données de Santé (HDS) certification in France and the Esquema Nacional de Seguridad (ENS) in Spain. Additionally, we adhere to the CISPE Code of Conduct, which offers a data protection compliance framework to assist cloud infrastructure customers in evaluating their providers’ compliance with GDPR.
With the introduction of the EHDS, we eagerly anticipate collaborating with various industries and policymakers to develop the technical infrastructure, standards, and tools necessary for effective health data sharing and analytics. Our aim is to empower customers to create trustworthy systems that foster innovation and research for the public good, thus reinforcing European sovereignty.
The EHDS has the potential to allow EU citizens and institutions to reap the benefits of transformative and ethical applications of health data, advancing healthcare, research, and understanding of diseases. Moving forward, it will be essential to establish thoughtful policy frameworks alongside cutting-edge technologies to ensure security, transparency, and control over health data. AWS offers over 240 fully-featured services, with comprehensive functionalities, application development, deployment, and management capabilities spanning 105 Availability Zones across 33 geographic regions, with plans for 18 additional Availability Zones and six more AWS Regions. We are dedicated to assisting our customers in implementing projects that contribute to the establishment of a dynamic EHDS that sets global benchmarks for the responsible use of sensitive data to enhance lives.
Projects by EU Member States
Each EU Member State will undertake its own projects and regulations as part of the EHDS implementation. For instance, France is leading initiatives to enhance health data sharing while safeguarding patient privacy. In 2019, the French government enacted legislation to transform the healthcare system by creating a digital health space (ENS), offering a secure, personalized platform for users to manage their health data and services. The Health Data Hub, a public structure in France, also facilitates secure access to anonymized data for researchers, in compliance with regulatory standards and citizens’ rights. Furthermore, France’s national AI strategy focuses on healthcare, fostering new applications and simplifying existing ones. AWS has consistently supported these initiatives by localizing its infrastructure in France and adhering to regulations like the HDS referential.
Germany is advancing its own national law, the Health Data Use Act (GDNG), to improve access to healthcare data, with the electronic patient record (EHR) acting as the central hub for healthcare data. Previously, researchers faced challenges accessing statutory health insurance data due to the limited adoption and regulation of the EHR. As a first step, the EHR will become mandatory by the end of 2024, with the German Ministry of Health intending the GDNG to facilitate the connection to the EHDS. This includes making health data available for secondary use, establishing data access points, and providing secure processing environments for data access.
Ireland has proactively worked to enhance the use of health data while protecting patient privacy through legislation such as the Data Protection Act 2018, which aligns with GDPR. The government’s eHealth strategy aims to bolster digital services and data sharing for integrated care. At the regional level, Ireland’s Health Service Executive is engaged in EHR adoption and data analytics projects. AWS supports Ireland’s initiatives with our AWS Europe (Ireland) Region and innovative cloud-based analytics services, collaborating with healthcare providers to transition to secure cloud infrastructure.
Italy is striving to enhance interoperability and utilization of health data through the national EHR known as the Fascicolo Sanitario Elettronico (FSE). The objective is to ensure patient data accessibility across all Italian regions in accordance with the EU’s EHDS plans. The NRRP national recovery plan heavily invests in digitizing healthcare through initiatives like home care, telemedicine services, and over 600 territorial healthcare operational centers. AWS supports Italy through our AWS Europe (Milan) Region, partnerships with healthcare providers for secure cloud migration, and compliance offerings to assist customers in meeting regulations like GDPR. As a trusted technology partner, we are committed to collaborating with Italy to develop the frameworks, infrastructure, and skills necessary for ethical health data utilization through the EHDS.
Spain has prioritized the advancement of digital health services while ensuring data protection. Since 2011, Spain has participated in the eHealth Network, which connects national authorities responsible for eHealth as designated by EU Member States. This network serves as the foundation for MyHealth@EU, a system dedicated to the primary use of healthcare data. Spain has allocated over €100 million for the development of a health data lake through the National Recovery Plan, and is currently crafting a National Health Data Space, expected to integrate with the future EHDS by 2025. To establish this national data space, the Spanish Government allocated €28 million in 2022 to ensure that all autonomous regions maintain adequate technological and organizational resources to make data available. The La Rioja regional health authority is one example, having developed a project called PASCAL, a data lake fully aligned with national and international standards.
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