- Ms Martina, thank you for joining us. Digital health is now at the centre of the European debate. How is the Commission working to balance technological innovation with the protection of patients?
Thank you for the invitation. Digital health is undoubtedly one of the most profound transformations currently taking place across European healthcare systems, and it is essential that this evolution keeps people and patients firmly at its core. The Commission’s objective is not to introduce technology for its own sake, but to use innovation as a means to tangibly improve citizens’ experience and support healthcare professionals in their daily work. Through initiatives such as
MyHealth@EU, and with the new regulatory framework established by the
European Health Data Space (EHDS), we are working to simplify access to health data, ensure the quality of clinical information and enable its reuse to improve care, prevention, research and transparency. At the same time, we are strengthening digital security and fostering a more open and dynamic ecosystem for research and innovation. In Italy, the EHDS can act as a powerful driver for standardisation and harmonisation within the national healthcare system, which—unlike those of some other Member States—is particularly complex due to its size, regional structure and technological diversity. This is an ambitious journey, requiring cooperation, trust and a shared vision among Member States, healthcare providers and industry.
- The European Health Data Space is expected to have a major impact on the digital health market by introducing EU-wide interoperability and standards. What are the Commission’s expectations?
The EHDS represents a decisive step towards a truly integrated digital health ecosystem. Today, the fragmentation of health information systems remains one of the main barriers to high-quality care: incompatible technologies, heterogeneous data formats and difficulties in exchanging clinical reports hinder continuity of care and slow down digital innovation. With the introduction of common standards - such as the
European Electronic Health Record Exchange Format (EEHRxF) - the Commission expects this fragmentation to be progressively overcome, enabling greater convergence among national systems. The European format is a real game-changer, as it allows healthcare systems to import and export clinical information in a structured and harmonised way. Its primary purpose is to improve the quality of care, while at the same time enabling a secure, privacy-respecting and efficient secondary use of health data to support research, innovation, evidence-based policymaking and transparency. The EHDS also introduces an innovative regulatory framework for placing
electronic health record (EHR) systems on the market. Once certified against harmonised requirements, an EHR system will be usable across the entire EU, offering significant benefits in terms of transparency, competition and administrative simplicity for market operators. In parallel, the EHDS will pave the way for a much more efficient and secure secondary use of data through
HealthData@EU. This infrastructure is not merely a data access channel, but a genuine trust mechanism, introducing shared rules, clear controls and harmonised processes to ensure that data is used safely, transparently and in the public interest. In this way, the EU will be able to support high-quality research, reduce asymmetries between Member States and strengthen its collective capacity to respond to current and future health challenges.
- What role will market players—such as healthcare software companies—play in this transformation?
The market will be a central actor in making the EHDS a reality. Companies developing healthcare software, and EHR system providers in particular, are not simply technology suppliers; they are essential partners in this transformation. They will be called upon to align their solutions and processes with shared requirements for interoperability, security and quality. At the same time, the EHDS opens up significant new opportunities. By harmonising technical rules and compliance requirements, it reduces market fragmentation and creates a more favourable environment for scaling digital solutions. In this new competitive landscape, success will no longer depend on the ability to adapt to multiple national contexts, but on product quality, system security and genuine interoperability. From 2029 onwards, only systems that comply with harmonised components will be allowed onto the EU market. In return, companies will gain access to the entire Single Market through a
single certification, with substantial benefits in terms of visibility and scalability. While some vendors may perceive this transition as challenging, it is also an extraordinary opportunity. The EHDS will enable companies to innovate more easily, deploy AI-based tools and develop advanced telemedicine and remote monitoring services that can finally integrate seamlessly into healthcare systems across Member States. Ultimately, the success of the EHDS will largely depend on the market’s ability to actively drive this transformation.
- Beyond the EHDS, recent regulations such as eIDAS 2 are shaping Europe’s digital ecosystem. What synergies do you foresee with the European Digital Identity Wallet?
The European Digital Identity Wallet is a cornerstone of the emerging European digital ecosystem, and its synergies with the EHDS are clear. The Wallet will allow citizens to securely identify themselves when accessing their health data, signing clinical documents or authorising data sharing. Italy has already made significant progress with its national digital wallet,
IO, which integrates public services and currently provides digital versions of documents such as the driving licence, the European Health Insurance Card and the European Disability Card. The IO app is expected to become fully compliant with
eIDAS 2 by the second half of 2026. Italy has also tested interoperability with the EUDI Wallet specifications through the
Large Scale Pilot POTENTIAL, including the issuance and presentation of Electronic Attestations of Attributes (EAAs). The Italian electronic identity system - based on the national ID card (CIE) and SPID - is compliant with assurance levels ranging from low to high. This will significantly simplify access to digital health services across the EU and help build trust, thanks to the direct control citizens will have over their identity and the data they choose to share. It will also facilitate the uptake of cross-border digital health services and make the patient experience more consistent, regardless of the Member State they are in - an essential step towards making digital health a tangible right rather than a theoretical one.
- Telemedicine and remote patient support are also addressed within the EHDS. What growth do you foresee for these solutions?
Telemedicine will finally be able to fulfil its full potential thanks to the EHDS, which removes its greatest obstacle: the lack of access to patients’ clinical history during remote consultations. With the adoption of the
EEHRxF, healthcare professionals will be able to access structured and up-to-date clinical information - subject to patient consent - enabling more accurate diagnoses and ensuring genuine continuity of care. This marks a fundamental shift towards a model in which data move, rather than patients. From March 2029, the mandatory cross-border exchange of
Patient Summaries and
ePrescriptions among all Member States will provide a solid foundation for secure teleconsultations, including across borders. This will also simplify the management of complex situations, such as the dispensing of specific medicines, while ensuring consistency and safety. Looking ahead, integration with remote monitoring devices and AI-based tools will enable more effective management of chronic conditions, earlier interventions through predictive models and more personalized prevention strategies. Projects such as
XpanDH and
XT-EHR are already helping to define the standards and best practices that will support this evolution, creating a more mature and interoperable environment in which telemedicine can grow sustainably.
- Digitalisation can also play a key role in prevention, sometimes supported by AI-based solutions.
Digitalisation is indeed a critical enabler of prevention. Access to complete, accurate and interoperable health data makes it possible to build reliable predictive models, identify risk factors at an early stage, optimise screening programmes and promote proactive care models. When used responsibly and trained on high-quality datasets, artificial intelligence can provide powerful support for prevention and anticipatory health management. In this context,
HealthData@EU will play a pivotal role by enabling researchers and innovators to access high-quality aggregated and pseudonymised data. This will not only accelerate the development of AI-based solutions, but also ensure that data are used in an ethical, secure and transparent way.
- EU programmes such as Horizon Europe often enable a transition “from project to infrastructure,” as demonstrated by MyHealth@EU. What could be the next success story?
One initiative with strong potential to become the next major success story is
HealthData@EU itself. Just as MyHealth@EU has made cross-border health data exchange a practical reality, HealthData@EU could become the reference infrastructure for secondary data use in research, innovation and evidence-based policymaking. It is a complex undertaking, combining quality, security and public governance in a model that is unique at international level. Alongside this, several European projects are contributing to the construction of the digital health ecosystem and may, over time, evolve into permanent infrastructures. Among these,
SHAIPED plays a particularly important role in improving the quality, standardisation and interoperability of datasets used by AI in healthcare, ensuring they can be reliably applied in both clinical and research settings. Equally significant is
QUANTUM, which develops methodologies and tools to ensure the quality of health data and assessment processes, so that information shared within the EHDS is accurate, complete and genuinely useful for both care delivery and analysis. These initiatives also support greater harmonisation of the Italian healthcare system, fostering common standards and practices that facilitate convergence across regions and institutions. They are already demonstrating their capacity to mature and respond to concrete Member State needs, and may become key pillars of the EHDS in the future.
- To conclude, a call to action: how can Italian companies support and accelerate the digital transformation of healthcare?
The digital transformation of European healthcare requires an active contribution from industry, and Italian companies are particularly well positioned to add value. Member States are currently working together through two
Joint Actions -
XT-EHR for primary data use and
TEHDAS2 for secondary use - which are defining the recommendations that will underpin the nineteen EHDS implementing acts. These acts will set out, in detail, the standards and requirements of Europe’s future digital health system. It is therefore essential for the Italian industrial sector to engage in consultations and actively contribute to ongoing work. Early adoption of standards, investment in interoperability and security, collaboration with regional health services and universities to test new solutions, and the development of products designed to integrate smoothly into the EU Single Market are all strategic steps that can position Italian companies as key players in this transformation. Digitalisation is not only a technological process - it is fundamentally a cultural one. It requires trust, skills, collaboration and a shared vision for the future. Italy has a vibrant, creative and highly skilled industrial ecosystem, and the EHDS can serve as a powerful catalyst for harmonising healthcare practices and improving the overall quality of clinical data, with tangible benefits for citizens, professionals and research alike. Now is the right moment to help build - together with other Member States - a digital health system that is more effective, secure and closer to citizens.