With the EU Health Technology Assessment Regulation (HTAR) now in its implementation phase and the European Health Data Space (EHDS) Regulation formally adopted and entering its transition phase, attention is rapidly shifting from legislative ambition to practical implementation. While the HTAR focuses on assessing at the EU level the clinical aspects of new health technologies, the EHDS aims to transform how data for those assessments will be accessed and used. Together, these initiatives signal a fundamental recalibration of how Europe evaluates, adopts and monitors health technologies. Yet their real impact will depend on how effectively Member States, regulators, industry, policymakers, patients and the other end-users translate this framework into day-to-day practice.

On 13 January, one year after the start of the implementation phase of the HTAR, the European Patients’ Forum hosted a webinar to showcase the work carried out in 2025 to ensure meaningful patient involvement from the very start of implementation. The EU-funded European Digital Health Technology Assessment (EDiHTA) project was also featured, showcasing how it actively integrates patient perspectives into its framework, with a strong emphasis on relevance, fairness, and accessibility for patients.

The webinar highlighted several key messages from speakers representing patient organisations, individual patient advocates, and the European Commission:

• Patient involvement in the HTAR process was achieved gradually, through the persistent efforts of patient organisations, which, through concrete cases and practical examples, clearly demonstrated the added value of their engagement.
• Patient involvement is essential to ensure that the HTAR meets its objectives and responds to patients’ needs, notably improving access to treatments across Europe and supporting greater harmonisation of HTA among EU Member States.
• Patients and patient organisations play a crucial role in the HTAR process, as they are best positioned to provide real-world insights into what works in practice under this new EU framework and to highlight areas where improvements can still be made.
• Further steps must be considered, including tackling language barriers, ensuring that patients and patient organisations are appropriately involved, clarifying rules on conflicts of interest, and strengthening training opportunities. These efforts are needed not only to support meaningful patient involvement, but also to ensure that HTAR and HTA are better understood by a wider range of patients and that participation does not rely on the same individuals.

Reflecting on progress over the past year, following the start of the implementation phase for the HTAR and as EHDS moves through its transitional phase, significant strides have been made, yet careful attention is needed as the EU moves from legislative groundwork to operational implementation.

Within this evolving landscape, EDiHTA sits at the intersection of the HTA Regulation and the EHDS, aiming to establish a dedicated framework for evaluating digital health technologies, one of the most complex frontiers in health technology assessment. The dynamic, iterative development of digital health technologies, their reliance on real-world performance, and their frequent updates present challenges that traditional HTA methodologies are not well equipped to address.

In response to these challenges, EDiHTA illustrates how tailored methodologies for digital health technologies can bridge this gap between rapid technological evolution and rigorous assessment standards. Success will require continuous collaboration among key stakeholders, a commitment to learning from early implementation experiences, and ensuring that digital health technologies are evaluated in ways that truly enhance patient access and outcomes across Europe.