European efforts to modernize healthcare and research infrastructure reached two major milestones in 2025: the launch of the European Health Data Space (EHDS) and the implementation of the European Health Technology Assessment (EU HTA). Both initiatives aimed to improve care for EU citizens and to support the development of one of the world’s largest research datasets.

Experts presenting at an online press conference hosted by the Association of the Scientific Medical Societies in Germany (AWMF) outlined the opportunities and challenges.

Rolf-Detlef Treede, MD, PhD, president of the AWMF and chair of neurophysiology at the Medical Faculty Mannheim of Heidelberg University in Heidelberg, Germany, said that both initiatives stem from the EU’s Cross-Border Healthcare Directive 2011/24/EU, which aims to prevent discrimination based on nationality when people receive medical care in another EU country. He noted that a unified assessment process for medical products is essential to improve equitable access across the EU.

“We still face several challenges, including interoperability, which requires making national coding and billing systems compatible for data exchange,” said Treede. From the AWMF perspective, one of the key current challenges and priorities is ensuring data quality.

“Only valid data relevant to medical treatment and research should be stored and used. Billing and revenue data that should not influence medical treatment should not be included or considered,” he said.

Stefanie Weber, MD, who heads the Division of Coding Systems and Registers at the Federal Institute for Drugs and Medical Devices in Cologne, described the EHDS as structured around two major pathways: primary use and secondary use of data.

For primary use, EU citizens should have more control over and access to their health data:

• The electronic availability and portability of one’s own health data enable more personalized, better, and safer healthcare.
• The results of research and development based on well-structured data have provided new insights into diagnostics and therapy, which can result in better patient care.

Simultaneously, healthcare across national borders should become more efficient through the secure and standardized exchange of health data; doctors should be able to access important diagnostic data, even in other EU countries. Citizens should be able to redeem their e-prescriptions at any pharmacy in the EU. Secondary use of health data is designed to strengthen research and innovation. With pseudonymized information from approximately 450 million EU citizens, the EHDS could become one of the world’s most comprehensive health data resources. This could provide new insights into disease mechanisms and the development of new therapies. According to Weber, the first statutory regulations are planned for 2027, and the first implementations are planned for 2029.

Benefit Assessment of Medical Devices

With the launch of the EU HTA, the benefit assessment of a new medicinal product will gradually be shifted from the national to the European level, as noted by Bernhard Wörmann, MD, from the Department of Hematology, Oncology, and Tumor Immunology, Department of Medicine, Charité University Medicine Berlin, Berlin, Germany, and chairman of the AWMF’s Standing Committee on Pharmaceuticals.

“For almost 30 years, the European Medicines Agency (EMA) has been responsible for authorizing medicines at the EU level. However, access to medicines across individual countries remains extremely heterogeneous,” Wörmann said.

For instance, the EMA has authorized 142 new medicinal products in recent years for the treatment of various blood disorders. Across Europe, access ranged from 20% to 95%, Wörmann noted.

“This means that within the 27 EU member states, some countries have access to only one fifth of authorized products,” Wörmann emphasized. Germany ranked highest in terms of access, followed by Austria and Switzerland.

A core element of the EU HTA is “comparative effectiveness,” which evaluates the value of a new medicine relative to the existing standard of care. This assessment requires an accurate understanding of the existing treatment landscape; however, the standards differ widely. 

“The standard is the same only when there has been no new medicinal product in the last 20 years,” Wörmann explained. However, for dynamic conditions, such as leukemia, lymphoma, or multiple myeloma, for which more than 10 new medicinal products have emerged, the standard depends on whether the preceding product is available in each country.

Wörmann noted that the initiative offers many opportunities, including faster and more equitable access to new medicinal products in all EU member states. He also sees risks: replacing the well-established national Pharmaceutical Market Reorganization Act process with an untested EU procedure and increased complexity, because care situations across all EU member states would need to be considered. “Comprehensive expertise from research and guideline development is essential. Scientific societies in the member states must therefore be structurally and early involved in the process,” Wörmann emphasized.

Distorted or Incomplete Data Harm

According to Jana Hassel, specialist attorney for medical law and an adviser on digital policy at BAG SELBSTHILFE e.V. in Düsseldorf, Germany, the EHDS and therefore European data sharing “can significantly improve the health of patients.”

Hassel highlighted the following aspects:

• Drug therapy safety: Faster detection of adverse events and interactions through EU-wide evaluation of real-world data.
• Cross-border care: Improved continuity of treatment abroad through access to complete medication and treatment data.

Hassel also stressed that key challenges must be addressed to ensure a patient-oriented EHDS, including data quality. “To unlock this potential, the central question at every single step toward the European Health Data Space must always be: What do patients gain from this? This question is not always prioritized, and from our perspective, which is currently a problem,” Hassel explained.

The goal of medical treatment is to prevent harm to patients. “This requires that the quality of data entering the European Health Data Space is very high. Only valid data relevant to treatment may be used,” Hassel emphasized. Distorted or incomplete datasets markedly reduce the potential benefits and may even cause harm. Hassel warned, “No one will be willing to share their data voluntarily if they fear that sharing may disadvantage them.”

This story was translated from Medscape’s German edition.