The European Health Technology Assessment Regulation: State of the Art and Challenges
The European Health Technology Assessment (HTA) Regulation (EU 2021/2281), which came into force on January 12, 2025, marks a pivotal moment in the evaluation of health technologies across the EU. Its primary goal is to enhance coordination among Member States through Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), ensuring greater efficiency and consistency in healthcare decision-making across Europe.
In the latest edition of DIGI-MEd, Rossella Di Bidino, HTA expert at Fondazione Policlinico Universitario A. Gemelli IRCCS and Head of the Unit on HTA for A.I. at the Advanced School of Health Economics and Management at ALTEMS, dives deep into the critical aspects of this regulation. She addresses the methodological challenges, the role of the PICO framework, and the implications for pharmaceutical companies, medtech startups, and digital health professionals.
Key Insights from the Editorial:
- Consolidating Clinical Assessments at the European Level: The HTA Regulation sets the stage for standardized clinical assessments across the EU, facilitating a unified approach to health technology evaluation.
- Harmonizing National and EU Regulations: One of the major challenges remains harmonizing the diverse regulatory frameworks of individual Member States with the overarching EU regulations.
- The Crucial Role of Stakeholder Engagement: For effective implementation, it is essential to involve all relevant stakeholders—ranging from healthcare providers to technology developers—in the HTA process.
Click here to read the full editorial on DIGI-MEd!
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