Toward a Digital Health Union

The European Health Data Space, biotech and pharma reforms, and MDR review – the EU’s health initiatives are entering a critical phase. Their shared goal is to modernize healthcare through innovation and streamlined regulation. Eva Hrncirova, Commission Spokesperson for Health and Food Safety, explains the priorities shaping the EU’s health agenda.

• Supportive regulatory framework: The Commission is advancing reforms including the EHDS Regulation, Critical Medicines Act, and pharmaceutical legislation to enhance access to medicines and secure supply chains.
• Boosting AI in healthcare: The EU AI Act, alongside EHDS, is designed to promote trustworthy, safe, and innovative AI solutions, with tools like regulatory sandboxes and a €200 billion investment initiative.
• Simplification for innovators: Recognizing challenges faced by digital health startups, the EU is evaluating medical device regulations and GDPR burdens, aiming to streamline processes while safeguarding public health.
• Vision for the European Health Union: The long-term goal is a connected, resilient, and equitable health system across Europe, focused on faster access to treatments, prevention, and strategic preparedness.

At the EU Health Summit, the EU Commissioner for Health and Animal Welfare, Olivér Várhelyi, highlighted the urgent challenges facing European healthcare: an aging population, rising chronic disease rates, workforce shortages, and escalating costs. To address these issues, the EU aims to lead digital innovation, leveraging AI, biotechnology, and health data to reshape healthcare across the continent. What are the three key initiatives the European Commission is focusing on?

Strengthening healthcare in the EU is a major priority for this mandate.

By completing the European Health Union, we aim to build a modern, competitive, innovative, and resilient EU health ecosystem that delivers for citizens. Among the key initiatives we focus on are the European Health Data Space (EHDS), the pharmaceutical reform, the Critical Medicines Act, implementing the Regulation on Health Technology Assessment, the Biotech Act, and the Cardiovascular Plan. 

The EHDS Regulation is an important milestone in the EU’s efforts to build a secure and efficient digital health ecosystem as part of the European data strategy. It entered into force on 25 March, and the Commission will work closely with Member States, healthcare providers, researchers, and industry stakeholders to ensure smooth and effective implementation.

The reform of the EU pharmaceutical legislation is currently being negotiated with the Council, while the European Parliament adopted its 1^st reading position on 10 April 2024. The reform of the pharmaceutical legislation is essential to promote timely and equitable access to medicines for all EU patients, and to ensure a competitive and innovation-friendly pharmaceutical regulatory framework. It is complemented by the proposal for a Critical Medicines Act (CMA), which we adopted in March 2025 within the first 100 days of the mandate. The CMA will increase the resilience of supply chains by diversifying them and strengthening pharmaceutical manufacturing in the EU.  

The Regulation on Health Technology Assessment, which became applicable in January, aims to ensure that innovative and effective health technologies are available to patients across the EU. This Regulation will also ensure the efficiency and quality of assessments for medical treatments and devices and help avoid duplication of work for both Member State authorities and health technology developers. We are now working hard with Member States on its implementation.

Finally, the European Biotech Act, which we intend to propose in 2026, will tap into the potential of AI and big data, enhance skills development, and improve access to funding to benefit the whole health sector and EU patients. In developing this Act, the Commission will also explore the scope for simplifying regulatory procedures.  

EHDS is a mega-project. What are your expectations?

The entry into force of the European Health Data Space marks a historic step in building a true European Health Union. We are laying the foundations of a comprehensive digital health framework that will empower citizens, transform healthcare systems, and accelerate research, innovation, and competitiveness across the EU.

First, citizens will be able to access and control their personal health data seamlessly across borders. This is essential for better, more efficient care. Second, the EHDS will create an unprecedented boost for research, innovation, and public health policy. By making health data available in a secure and trustworthy way for secondary use – by researchers, regulators, and innovators – we can unlock new treatments, better disease prevention strategies, and faster responses to future health crises.

And finally, the EHDS is a critical step toward the digital transformation of healthcare systems across the EU: it creates clear rules, common standards, and strong governance, bringing legal certainty and a unified approach to data sharing in the health sector.

What’s at stake for healthcare professionals, citizens, scientists, and entrepreneurs? 

The EHDS is a big milestone, but the following years will be crucial to ensure it is fully and adequately implemented. The Commission is working hand-in-hand with Member States, because the EHDS can only succeed if countries take ownership from day one. It is a collaborative effort that depends on national authorities, health professionals, and innovation ecosystems coming together.

For healthcare professionals, the EHDS means quicker, more complete access to information about their patients. This will contribute to more accurate diagnoses, better treatment coordination, and less administrative burden. However, it requires investment in digital infrastructure and training – steps that national systems must take now to reap these benefits.

For citizens, the EHDS will give secure access to their electronic health records, prescriptions, test results, and more – no matter where they are in Europe. For this vision to become a reality, Member States will have to step up their ongoing efforts to implement the necessary digital tools and interoperability standards.

For scientists, the EHDS will open new frontiers in health research. Easier access to real-world health data across the EU means more robust studies, better evidence, and faster innovation. Also, in this area, while the Commission will be responsible for the central services, Member States will be responsible for setting up national health data access bodies and contributing to the shared infrastructure.

And for entrepreneurs and startups, EHDS will reduce barriers to innovation. Clear EU-wide rules and a level playing field will stimulate the development of new digital health services, diagnostics, and AI-based solutions. Engaging now means shaping the future of European health innovation from within.

In short, what’s at stake is the future of European healthcare – more connected, personalized, and equitable. Member States that act early will be at the forefront of this transformation. 

During the AI Action Summit in Paris, some warned that excessive restrictions could “kill artificial intelligence.” How do you see the impact of the EU AI Act on the EHDS, particularly regarding data-driven innovations like health algorithms?

The AI Act and the EHDS Regulation will significantly stimulate innovation in AI in healthcare in Europe.

The AI Act promotes AI innovation in several ways. First, it will ensure that AI solutions that enter the European market are safe and transparent and respect data privacy. As such, the AI Act increases the trust in AI solutions, including the trust of patients and healthcare professionals. This is crucial for increasing demand and uptake of AI in healthcare in Europe. Second, the AI Act increases legal certainty and harmonizes rules across the EU. This means that companies can access bigger markets, with products that users and consumers appreciate and purchase. This will be highly relevant across sectors, including the healthcare sector.

Finally, the AI Actenables regulatory sandboxes. Regulatory sandboxes are controlled environments for developers to test innovative technologies under real-world conditions, including healthcare applications. This will significantly facilitate and promote AI solutions’ development, testing, and deployment across sectors, including healthcare.

The EHDS will play a crucial role in advancing AI in healthcare in Europe. The EHDS will make available the health data needed for researchers and innovators to develop, test, and validate AI solutions in healthcare.

The combination of the AI Act and the EHDS will boost the development and scale-up of innovative, safe, and effective AI that will provide concrete benefits to healthcare systems and patients.

Trust is a key element of the EHDS, which is why strong privacy, security, and data protection measures are at the core of the EHDS legislation. Security is key to delivering the EHDS. Therefore, the EHDS Regulation contains data protection and security safeguards (e.g., logging in to electronic health record systems or data reuse in secure processing environments). These safeguards will be further developed when the acts are implemented.  

Do you think some degree of deregulation in healthcare is necessary to accelerate innovation?

Creating an environment conducive to innovation is a high priority for the Commission. The health sector is one in which Europe has a competitive advantage over other regions. We must maintain this. As part of the Commission’s broader simplification agenda, we will look at opportunities to simplify and streamline the regulatory environment while maintaining a high level of health protection. 

In the field of medical devices, we are currently evaluating the Regulations on medical devices (MDR) and in vitro diagnostics (IVDR) to assess the potential need for legislative amendments. The aim is to explore the need to simplify the regulations and reduce the burden to ensure a proportionate approach to allowing innovative devices on the market and to reach patients. This approach aims to contribute to a high level of public health while supporting the sector’s competitiveness. In the short term, we’ll put forward measures to simplify implementation and reduce administrative burden already this year.

The pharmaceutical reform balances incentives for innovation with the need for access to safe and effective medicines in Europe. The proposed reform contributes to the Commission’s simplification agenda by reducing the administrative burden for both medicine developers and authorities, making the framework more agile and future-proof. The reform also proposes increasing the speed and efficiency of the processes while maintaining high standards for the quality and safety of medicines in the EU.

The proposal for a Critical Medicines Act defines criteria to recognize projects that create, increase, or modernize manufacturing capacity for critical medicines as Strategic Projects. These projects may benefit from easier administrative procedures, as well as financial support.

Additionally, we will propose a Biotech Act to ensure that Europe’s biotechnology sector can compete globally. We want to support the development of biotech solutions and make it easier to bring biotech from the laboratory to the factory and then to the market. 

The Clinical Trials Regulation became fully applicable in January 2025, and it is a great step forward, streamlining the authorization procedure, facilitating information sharing among Member States, and increasing transparency of the clinical trial process. However, experience during the transitional period has signaled some challenges that could be addressed with targeted simplifications. Therefore, in developing the Biotech Act, the Commission will also explore the scope for simplifying regulatory procedures in the context of clinical trials.

Will the €200 billion investment in AI development, announced by European Commission President Ursula von der Leyen, also support AI in healthcare? 

Yes, it will also support AI in healthcare. As Commission President Ursula von der Leyen announced, AI will improve our healthcare, spur our research and innovation, and boost our competitiveness. The next-generation AI models require extensive computing infrastructure for breakthroughs in specific domains such as medicine or science.This is why, together with our Member States and partners, we will mobilize unprecedented capital through InvestAI to enable the development of advanced very large language models in the EU. Such initiatives will boost the development and use of AI, also in healthcare, and speed up the concrete benefits of AI to healthcare and patients in the EU.

You announced a review of the EU’s medical device regulations. Do you believe the MDR also needs adjustments regarding digital health solutions? 

The European Commission is currently conducting a targeted evaluation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The public consultation and call for evidence ended on 21 March, and we are now analysing the many replies received, along with additional evidence. As mentioned by Commissioner Várhelyi, we will present the conclusions of this evaluation by the end of this year and then determine the follow-up actions to be taken.

Digital health startups often struggle with regulations like GDPR and MDR when developing and scaling their products in Europe. How do you plan to address this challenge? 

As part of the targeted evaluation mentioned above, we will also examine the impact of the MDR and IVDR on small and medium-sized enterprises (SMEs) and start-ups, as well as their interaction with other EU legislation. Where we identify any disproportionate administrative burdens or specific challenges, the Commission will consider appropriate measures to simplify and reduce these burdens and address those challenges. On top of that, the Commission is planning to adopt an EU Start-up and Scale-up Strategy.

The Commission is reviewing several pieces of legislation to simplify rules and reduce administrative burden, particularly for SMEs.

Further information on the Commission’s approach to simplification, including priorities and possible areas of focus for the Digital Package, can be found in our ‘ Simpler and Faster Europe’ communication.

How do you envision the European Health Union at the end of this Commission mandate? 

The aim is to complete the European Health Union so that we have a modernized, competitive, innovative, and resilient EU health ecosystem that delivers for all EU citizens and brings the best treatments to all, faster.

A key focus will be on boosting the competitiveness, resilience, and security of healthcare across Europe, diversifying supply chains, improving access to the most advanced treatments, and working on strategic inventories. The EHDS, the Critical Medicines Act, the modernized pharmaceutical legislation, the review of our medical devices rules, and a new European Biotech Act are key initiatives in this mandate that will help us bolster the Health Union. And we’ll also put a strong focus on preventive health, including ambitious action against cancer and cardiovascular diseases, continued work on mental health, and a determined fight against antimicrobial resistance.

---