Publication Digest: An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Bloemen et al. analyzed the procedures and methods used by health technology assessment (HTA) agencies in evaluating medical devices, focusing on the normative commitments of HTA practitioners. The authors revealed that existing drug-focused frameworks and practical constraints limit innovation, underscoring the need for a re-evaluation of HTA roles and institutional changes to support methodological advancements tailored for medical devices.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Tarricone et al. analyzed assessment frameworks for digital medical devices (DMDs) across the EU to identify prevailing regulatory and reimbursement approaches. The study categorized these frameworks into the following five clusters: integrated national systems combining regulation and reimbursement, decentralized or non-reimbursement-linked frameworks, institutional certification processes lacking standardization, preparatory systems, and countries with underdeveloped infrastructures. The authors emphasized the cross-country learning effects, expediting the harmonization of approaches to foster innovation and improve access to DMDs across the EU.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Schramm et al. conducted a structured literature review to identify key success factors for the sustainability of digital health applications (DiGAs) under Germany’s Digital Supply Act. Their findings highlight the importance of patient-centered design, application effectiveness, user-friendliness, and robust data security measures in ensuring the long-term success of DiGAs and advancing digital transformation in European healthcare systems.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Di Bidino et al. conducted a Delphi survey among 46 experts to identify critical topics for developing a health technology assessment (HTA) framework tailored to AI-based health technologies (AIHTs). The study revealed 48 key topics, highlighting the most crucial: accuracy of the AI model, patient safety, ethical benefit-harm balance, and bias in data. The authors highlighted gaps in the EUnetHTA Core Model, proposing a comprehensive framework to guide the evaluation of AI tools like those being developed in the European AI-Mind project for early dementia diagnosis.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Zisis et al. conducted a systematic literature review to assess the current use and acceptance of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) processes. The authors aimed to discern stakeholders' viewpoints on RWD and RWE, highlighting obstacles, difficulties, prospects, and consequences associated with their incorporation into HTA. The review emphasized the importance of recognizing regional nuances, addressing methodological challenges, and promoting collaboration for leveraging RWD and RWE effectively in healthcare decision-making.