European Health Data Space will enable health innovation through secure data sharing

In May 2022, the European Commission (EC) proposed to set up a European Health Data Space (EHDS). The EHDS will establish a common framework and infrastructure for the use of health data for research, innovation, policy-making, and regulatory activities in the European Union (EU). It will also create common standards and practices enabling EU citizens to better access, control, and share their electronic personal health data. In April 2024, the European Parliament adopted the proposed EHDS Regulation. With the European Council expected to follow suit, we appear set to see the first common EU data space come into force by the close of 2024.

AWS can support implementation of the EHDS

At Amazon Web Services (AWS), we welcome the EHDS as an important step towards unleashing the vast potential of health data to benefit citizens across Europe and beyond. The EHDS has the opportunity to establish Europe as a global leader in ethical and privacy-preserving approaches for health data use.

As the world’s most comprehensive and broadly adopted cloud provider, we recognize our role and responsibility in supporting customers to use health data securely and responsibly. We have long invested in developing capabilities and services tailored to the unique privacy and security needs of the healthcare sector, and we are committed to supporting open source, open data, and open standard communities.

At AWS, security will always be our top priority. AWS is architected to be the most secure cloud computing environment available today. Our core infrastructure is built to satisfy the security requirements for high-sensitivity industries such as healthcare. We have worked diligently to comply with internationally recognized standards, including being the first cloud provider to receive the Cloud Computing Compliance Controls Catalog (C5) attestation in Germany and, more recently, the Hebergement de Données de Santé (HDS) certification in France, and the Esquema Nacional de Seguridad (ENS) in Spain. AWS also adheres to the CISPE Code of Conduct, which provides a data protection compliance framework to help cloud infrastructure customers assess their providers’ compliance with GDPR.

With the EHDS, we look forward to collaborating across industries and with policymakers to develop the technical infrastructure, standards, and tools for appropriate health data sharing and analytics. We are committed to empowering customers to build trustworthy systems to promote innovation and research for the public good and strengthen European sovereignty.

The EHDS can pave the way for EU citizens and institutions to benefit from transformative, ethical uses of health data, advancing care, research, and understanding of disease. The path forward necessitates thoughtful policy frameworks combined with cutting-edge technologies to enable security, transparency, and control of health data. AWS offers more than 240 fully featured services, with the deepest functionality within those services, and application development, deployment, and management from 105 Availability Zones within 33 geographic Regions, with announced plans for 18 more Availability Zones and six more AWS Regions. AWS is committed to helping our customers implement projects that will contribute to building a vibrant EHDS, one that sets global standards for the responsible use of sensitive data to improve lives.

EU member state projects

EU Member States will each have their own projects and regulations, which will contribute to the implementation of the EHDS. For example:

France has been at the forefront of initiatives that enhance the sharing and utilization of health data while ensuring patient privacy. In 2019, the French government passed legislation transforming the healthcare system by establishing a digital health space (ENS). This space provides a secure, personalized platform for users to manage their health data and services. The Health Data Hub, which is a French public structure, also enables researchers to access anonymized data securely, in compliance with regulatory standards and citizens’ rights. Additionally, France has rolled out a national artificial intelligence (AI) strategy, particularly focused on healthcare, which is regularly updated to foster new applications and simplify existing ones. AWS has consistently supported these French initiatives by localizing its infrastructure in France and adhering to regulations like the HDS referential.

Germany has proposed its own national law, the Health Data Use Act (GDNG), to improve access to healthcare data. The electronic patient record (EHR) will serve as the central hub for healthcare data. Until now, researchers have not been able to access the data of people with statutory health insurance because the EHR was not widely adopted and access was not regulated. As a first step, the EHR will now be made mandatory by the end of 2024. The German Ministry of Health intends the GDNG to take the first steps towards connecting to the EHDS. This includes making health data available for secondary use, setting up data access points, and making the data available through secure processing environment.

Ireland has taken a proactive approach to enabling better use of health data while protecting patient privacy through legislation like the Data Protection Act 2018, which aligns with GDPR. The government’s eHealth strategy aims to improve digital services and data sharing for integrated care. At the regional level, Ireland’s Health Service Executive is working on EHR adoption and data analytics projects. AWS supports Ireland’s efforts through our AWS Europe (Ireland) Region and innovative cloud-based analytics services as well as working with healthcare providers to transition to secure cloud infrastructure.

Italy is working to improve the interoperability and use of health data through the national EHR called the Fascicolo Sanitario Elettronico (FSE). The goal is to make patient data accessible across all Italian regions in line with the EU’s plans for EHDS. The NRRP national recovery plan invests heavily in digitizing healthcare through initiatives like home care, telemedicine services, and more than 600 territorial healthcare operational centers. AWS supports Italy through our AWS Europe (Milan) Region, partnerships with healthcare providers to migrate securely to the cloud, and compliance offerings to help customers meet regulations like GDPR. As a trusted technology provider, we look forward to working with Italy to develop the frameworks, infrastructure, and skills required to enable ethical health data use through the EHDS.

Spain has prioritized advancing digital health services while ensuring data protection and, since 2011, has been part of the eHealth Network. This network, that connects national authorities responsible for eHealth designated by EU Member States, is the platform on which MyHealth@EU, the system for the primary use of healthcare data, will be built. Spain has allocated more than €100 million for the development of a health data lake through the National Recovery Plan and is already developing a National Health Data Space, which is expected to be completed by 2025 and will be integrated into the future EHDS. In order to set up this national data space, in 2022, the Spanish Government approved the territorial distribution of €28 million to ensure that all the autonomous regions maintain a sufficient level of technological and organizational resources to make the data available. Some examples of the regional programs: La Rioja regional health authority has developed a project called PASCAL, a data lake fully aligned with national and international Health Data Space. And Cantabria Health Authority has been certified as a data partner in the European Health Data and Evidence Network.

AWS is ready to help

Building the EHDS will require significant development work and strong partnership across government, industry, and civil society. AWS stands ready to collaborate with policymakers, and support our customers and partners, to drive EHDS implementation and ensure that patients, researchers, innovators and regulators fully benefits from the potential offered by safe and secure exchange, use and reuse of health data.

Learn more by visiting the AWS for Healthcare and Life Sciences homepage. If you have questions about the EHDS, and your use of AWS, contact us. We have a team of regulatory and technology experts with a background in healthcare and life sciences ready to support you.