The European Health Data Space (EHDS): A new era for EU health data management
Off the back of the COVID-19 pandemic, and as part of the broader European strategy for data, the European Health Data Space (EHDS) aims to create a unified framework for the use of electronic health data across the EU, benefiting researchers, healthcare providers, and patients alike.
With the proposal approved in April 2024, and enforcement set to begin in 2026, the European Health Data Space (EHDS) marks a significant milestone in managing health data across the European Union.
Key provisions
The EHDS applies to both primary and secondary use of patient electronic health data and sets out new measures and rules for its handling.
Primary use of data: empowering individuals
Access and control: patients can access, manage, and share their health records across EU member states, putting them in control of their personal health data.
Improved healthcare delivery: primary data facilitates cross-border medical services, seamless care, and continuity for patients traveling or living in different EU countries.
Secondary use of data: facilitating research and innovation
Data sharing: public and private entities can share health data with health data access bodies (HDABs), which provide secure access to researchers and innovators. Data users typically access anonymized data, although pseudonymized data is available if necessary for specific research purposes.
The role of Health Data Access Bodies (HDABs)
Health Data Access Bodies (HDABs) are instrumental in managing data requests and compliance with EHDS regulations. They are responsible for conducting regular audits of data users, evaluating data access applications to ensure they meet compliance standards, and issuing permits that specify the terms and conditions for data use.
Additionally, HDABs coordinate with various stakeholders - including patient organizations, healthcare professionals, ethical committees, and national supervisory authorities - to align standards and practices. They provide a secure data processing environment where data users can access and analyze health data, so that only anonymized or pseudonymized data is downloadable, thereby protecting personal information and data privacy.
What do the public think about the EHDS?
Public opinion on the EHDS is varied; some see it as a groundbreaking step towards improved healthcare and innovation, whilst others express concerns about data access and consent.
A 2024 Eurobarometer survey found that 38% of respondents wanted the EU to take concrete action to improve healthcare.
A 2024 European Commission report cited a 2021 public consultation where the majority of the respondents supported both primary and secondary uses of electronic health data. Specifically, 88% of respondents considered that the EHDS should promote citizens' control over their health data, including access to it and transmission in electronic format. This reflects a public desire for greater personal control over health information.
83% supported the EHDS facilitating the delivery of healthcare across borders, while 89% wanted the EHDS to support and accelerate health research.
The development of the EHDS was informed by these public consultations and feedback, demonstrating the EU's commitment to aligning the initiative with public expectations. The public consultation significantly influenced the EHDS framework and emphasized access to health data for healthcare provision, research, and policy-making.
Opt-out challenges with the EHDS
Health start-ups worry that the opt-out mechanism for secondary purposes will hinder operations due to insufficient data access, especially in countries with high opt-out rates. This could reduce the data pool, and pose barriers to researching and developing solutions for rare diseases.
One of the main disagreements during EU negotiations was whether an opt-out or opt-in mechanism would be better.
The EU Council and the Parliament eventually agreed to grant patients the right to withdraw their consent for their electronic data to be processed by third parties at any point. However, this opt-out can be overridden in certain public interest circumstances such as cross-border health threats and specific scientific research.
Requiring individuals to explicitly agree to share their data for secondary use could mean low participation, and undermine the representativity and usability of the data.
An opt-out option could lead to biased data collection if certain demographic groups withdraw their data en masse. These issues will have to be properly tackled by lawmakers going forward to ensure data remains representative and unbiased.
Data anonymization and data quality concerns
It remains unclear whether the responsibility for anonymizing data will lie with the data holders before sharing it with the HDABs, or with the HDABs themselves - which complicates the implementation process.
Thanks to opt-outs, there is concern about the quality of data and what sample size data will look like as a result. All data within EHDS will determine the value of the insights generated and health solutions developed through its secondary use - incomplete or unrepresentative datasets can introduce bias and lead to discriminatory outcomes for EU citizens.
Business implications
The EHDS presents numerous opportunities for businesses in the healthcare, biotech, and related sectors. Easier access to comprehensive health data sets will drive innovation and the development of new health technologies and personalized medicine solutions.
The EHDS’ streamlined processes and reduced fees for accessing health data will make research more efficient and cost-effective.
Without bureaucratic hurdles, the EHDS ensures that valuable time and resources can be directed toward innovation rather than administrative tasks. This potential for innovation positions companies to be at the forefront of medical advancements, ultimately benefiting the broader healthcare system and society at large.