Europe has begun 2025 with a dual, groundbreaking initiative: the European Health Data Space (EHDS) and the European Health Technology Assessment (EU HTA).
The EHDS is fundamentally changing the relationship between the patient and the medical system. This initiative breaks down bureaucratic barriers and empowers citizens to digitally manage and grant permission for the use of their data across the EU.
The EU HTA provides standardization for the process of evaluating and approving the value and effectiveness of new medicines across EU Member States. Instead of each country assessing a drug independently, the EU HTA creates a unified European framework to compare clinical benefits against existing standard treatments.
Both EHDS and EU HTA are based on the 2011 Cross-Border Healthcare Directive. They aim to eliminate two primary systemic challenges:
Fragmentation: Currently, access to medicines varies sharply between EU countries, ranging from 20% to 95%. EU HTA ensures that citizens have equal access to healthcare services regardless of which EU country they are in.
Research Delays: Isolated databases significantly hinder scientific progress and the effective monitoring of medication safety.
These tools create the world’s largest pseudonymized (non-identifiable) healthcare dataset, covering 450 million citizens. This is expected to result in savings of approximately €11 billion and provide faster, more equitable access to therapies, making the EU healthcare system a global gold standard.
Primary Use of EHDS
The Primary Use of EHDS relates directly to a patient’s daily medical care.
Instant Access: Patients gain immediate access to electronic records available across the EU. This improves quality by eliminating redundant tests and reducing medical errors.
Interoperability: Electronic prescriptions can be used in any EU pharmacy, and doctors can exchange patient data between member states for accurate, timely treatment.
Control and Privacy: Patients have full control over their data (adding notes, restricting access, correcting errors) and can Opt-out of secondary use for research. Data privacy is strictly protected by the GDPR and the Data Act.
Implementation Timeline:
By 2027: Regulatory rules will be approved.
2029: Exchange of patient summaries and e-prescriptions begins.
2031: Exchange of laboratory and imaging data becomes operational.
Secondary Use of EHDS
The Secondary Use of EHDS aims to promote science and innovation. This massive dataset opens unprecedented opportunities for identifying disease patterns and accelerating the development of new therapies, including treatments for rare diseases. It is expected to grow the digital health market by 20-30%, strengthening telemedicine and cooperation between member states.
Potential Risks and Barriers
Interoperability: Harmonizing codes, records, and languages between member states is essential for seamless data exchange.
Junk Data: Experts warn that using only valid clinical/research data is vital. Bias or flaws in data could lead to negative outcomes, as patients will not share data if they feel it is disadvantageous to them.
While the European Medicines Agency (EMA) approves drugs EU-wide, local accessibility remains unequal. For example, out of 142 approved hematological drugs, availability is 20% in some countries and 95% in others.
The EU HTA moves the Relative Effectiveness Assessment (comparing a new drug to standard treatment) to the European level. The project begins in 2025, focusing on: oncology and advanced Therapy Medicinal Products (ATMPs).
The launch is currently slower than planned. While 25 oncology assessments were scheduled for 2025, only about 10 are expected to be completed. This slowdown is primarily due to the pharmaceutical industry’s cautious approach as they adapt to new regulatory requirements across 27 national systems.
2025 marks the beginning of cardinal changes for European healthcare. Investments in data quality and ethical management will ensure the transformation of the EU healthcare sector into a unified, patient-centered system.
Source: Association of the Scientific Medical Societies in Germany (AWMF)
