In May 2022, the European Commission (EC) proposed the creation of a European Health Data Space (EHDS). The EHDS would 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 would also create common standards and practices to enable EU citizens to access, manage, and share their electronic personal health data. In April 2024, the European Parliament adopted the proposed EHDS Regulation. The European Council is expected to follow suit, with the first Common EU Data Space expected to come into force by the end of 2024.
AWS can help you implement EHDS
At Amazon Web Services (AWS), we welcome the EHDS as an important step towards unlocking the vast potential of health data to benefit people across Europe and beyond. The EHDS is an opportunity to establish Europe as a global leader in an ethical and privacy-preserving approach to the use of health data.
As the world’s most comprehensive and widely adopted cloud provider, we recognize our role and responsibility in helping our customers use health data safely and responsibly. We have long invested in developing capabilities and services tailored to the unique privacy and security needs of the healthcare sector, and are committed to supporting the open source, open data, and open standards communities.
At AWS, security has always been our number one priority. AWS is designed to be the most secure cloud computing environment available today. Our core infrastructure is built to meet the security requirements of sensitive industries such as healthcare. We have worked diligently to comply with internationally recognized standards, including being the first cloud provider to achieve Cloud Computing Compliance Controls Catalog (C5) certification in Germany, and more recently achieving the Hebergement de Données de Santé (HDS) certification in France and the Esquema Nacional de Seguridad (ENS) certification in Spain. AWS also adheres to the CISPE Code of Conduct, which provides a data protection compliance framework to help cloud infrastructure customers assess a provider’s GDPR compliance.
At EHDS, we want to work with policymakers across industries to develop technology infrastructure, standards and tools for appropriate health data sharing and analysis. We are committed to helping our customers build trustworthy systems to foster innovation and research in the public interest and strengthen European sovereignty.
EHDS can pave the way for EU citizens and institutions to benefit from transformative and ethical use of health data to advance healthcare, research, and understanding of disease. Moving forward requires a thoughtful policy framework combined with cutting-edge technology that enables security, transparency, and control of health data. AWS offers over 240 fully featured services with the deepest capabilities, and the ability to develop, deploy, and manage applications from 105 Availability Zones in 33 geographic Regions, with announced plans to add 18 more Availability Zones and 6 AWS Regions. AWS is committed to helping customers implement projects that contribute to building a vibrant EHDS, one that will establish a global standard for the responsible use of sensitive data to improve lives.
EU Member States Projects
Each EU member state has its own projects and regulations that contribute to the implementation of the EHDS. For example:
France has been at the forefront of efforts to enhance the sharing and utilization of health data while ensuring patient privacy. In 2019, the French government passed legislation to transform the healthcare system by establishing a Digital Health Space (ENS). This space provides a secure and personalized platform for users to manage their health data and services. A French public structure, the Health Data Hub, also allows researchers to securely access anonymized data while complying with regulatory standards and citizens’ rights. In addition, France has rolled out a national artificial intelligence (AI) strategy specifically focused on healthcare, which is regularly updated to foster new applications and simplify existing ones. AWS has consistently supported these French efforts by localizing its infrastructure in France and adhering to regulations such as HDS referencing.
Germany has proposed its own national law, the Health Data Use Act (GDNG), to improve access to health data. The electronic patient record (EHR) serves as the central hub for health data. Until now, researchers could not access data of people with statutory health insurance, as EHRs were not widely adopted and access was not regulated. As a first step, EHRs will become mandatory by the end of 2024. The German Ministry of Health intends that the GDNG will 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 data available through a secure processing environment.
Ireland has taken a proactive approach to enabling the effective use of health data while protecting patient privacy through legislation such as the Data Protection Act 2018, which is compliant with GDPR. The government’s eHealth strategy aims to improve digital services and data sharing for integrated care. At a local level, the Irish Health Service is working on EHR adoption and data analytics projects. AWS is supporting Ireland’s efforts through the AWS Europe (Ireland) Region and innovative cloud-based analytics services, working with healthcare providers on their transition to a secure cloud infrastructure.
Italy is working to improve the interoperability and use of health data through its national EHR, called Fascicolo Sanitario Elettronico (FSE). The goal is to make patient data accessible throughout Italy, in line with the EU’s EHDS plan. The NRRP National Recovery Plan is investing heavily in digitizing healthcare through initiatives such as home care, telehealth services, and over 600 Regional Health Operational Centers. AWS supports Italy through our AWS Europe (Milan) Region, partnerships with healthcare providers to enable a secure transition to the cloud, and compliance services to comply with regulations such as GDPR. As a trusted technology provider, we look forward to working with Italy to develop the frameworks, infrastructure, and skills necessary to enable ethical use of health data through EHDS.
Spain has prioritized the promotion of digital health services while ensuring data protection and has been part of the eHealth Network since 2011. This network brings together the national authorities in charge of eHealth designated by the EU Member States and is the platform on which MyHealth@EU, the primary use system for health data, is built. Spain has allocated more than 100 million euros for the development of a health data lake through its National Recovery Plan and is already developing a national health data space, which will be completed by 2025 and integrated into the future EHDS. To establish this national data space, the Spanish Government approved a regional allocation of 28 million euros in 2022 to ensure that all autonomous communities maintain a sufficient level of technical and organizational resources to make the data available. An example of a regional program: the La Rioja Health Authority has developed a project called PASCAL, a data lake fully adapted to national and international health data spaces. The Cantabrian Health Department has also been certified as a data partner of the European Health Data and Evidence Network.
AWS can help
Building an EHDS will require a major development effort and strong partnerships across government, industry, and civil society. AWS stands ready to work with policymakers and support our customers and partners to advance the implementation of an EHDS so that patients, researchers, innovators, and regulators can benefit most from the possibilities offered by the safe and secure exchange, use, and reuse of health data.
To learn more, visit the AWS for Healthcare and Life Sciences home page. If you have any questions about EHDS or using AWS, please contact us. We have a team of regulatory and technology experts with healthcare and life sciences backgrounds to assist you.
