Author: Univ.-Prof. Dr. Matthias P. Schönermark, Chief Strategy Officer at Kintiga
At DIA Europe 2025, held from March 18-20 in Basel, Switzerland, two key topics were the implementation of the European Union Health Technology Assessment (EU-HTA) Regulation and the integration of Artificial Intelligence (AI) in healthcare—both areas of expertise for Kintiga. Here are my main takeaways:
European Union Health Technology Assessment (EU-HTA) Regulation
The EU-HTA Regulation (EU 2021/2282), adopted in January 2022, has been fully effective since January 2025. This regulation introduces a coordinated approach to evaluating new health technologies across EU member states, aiming to streamline assessments and enhance patient access to innovative treatments. At the conference, experts discussed the initiation of Joint Clinical Assessments (JCAs) under this regulation, emphasizing the need for preparedness among regulatory and market access teams. A dedicated training course, “How to Navigate the Future Parallel HTA and EMA Processes in the EU,” provided insights into aligning regulatory submissions with the new HTA processes. It became clear that regulatory and HTA strategies need to be aligned and that the often siloed organization within pharmaceutical companies needs to transform into a more agile, transdisciplinary, and strategically impactful entity.
Artificial Intelligence in Healthcare
AI’s transformative potential in healthcare was a central theme at DIA Europe 2025. The keynote session focused on the responsible development and implementation of AI technologies, highlighting their role in enhancing patient outcomes and reshaping medical practices. Dr. Peiling Yap, Chief Scientist at HealthAI, was among the expert speakers addressing these advancements.
Additionally, the conference featured a dedicated track on Data Science, Real-World Evidence (RWE), and AI. This track catered to professionals engaged in data science and AI applications within healthcare and medicines development, offering a platform to explore innovative approaches and share best practices.
It became clear that AI is still lacking concrete use cases. There was a lot of conceptual noise and talk about plausible possibilities, but most of the presented solutions seemed to be intelligent document management systems.
In contrast, Kintiga’s EPRI, which automates the writing, description, and interpretation of 1,000 tables per week in regulatory and HTA documents, stood out from the crowd. If you want to learn more about this AI-powered medical and regulatory writing tool, please do not hesitate to reach out.
Overall, DIA Europe 2025 provided a comprehensive forum for the regulatory pharma scene and showed that the traditionally separated disciplines of regulatory, HTA, pricing, and medical need to grow closer together and start redefining their traditionally Taylorist approach.
If you would like to discuss any of the above insights in more detail, or find out how Kintiga can support you with your strategy or AI enabled HTA submissions across Europe, please get in touch via enquiries@kintiga.com
