On May 26, 2025, the Innovation Committee at the Federal Joint Committee (G-BA) announced that 49 applications for innovation funding of healthcare research projects were accepted.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Gupte et al. conducted a review of accelerated approval pathways for medical devices in the United States and the European Union. The authors found that while the US Breakthrough Devices Program granted marketing authorization to just 12.3% of 1,041 designated devices between 2015 and 2024, approval was achieved substantially faster than through standard routes. In the EU, where no specific accelerated pathway exists, newly introduced Medical Device and Health Technology Assessment Regulations aim to harmonize approvals, with joint clinical assessments set to begin in 2026. The authors highlight that aligning regulatory, funding, and coverage policies is essential for device accessibility, and call for global convergence of standards and post-market surveillance to balance innovation with patient safety.

In May 2025, the National Institute for Health and Care Research (NIHR) in England released five Med Tech-related assessments in its HTA Journal, which concerned the evaluation of high-flow nasal cannula therapy in pediatric critical care, assessment of IVD tests for guidance of antibiotic treatment, and the results of the research on clinical and cost-effectiveness of first-trimester ultrasound screening for fetal anomalies. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS, and informs NICE guidance.

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, Dietrich examined the current and potential roles of artificial intelligence in pricing, reimbursement, and market access (PRMA) processes, focusing on Germany and broader EU implications. The study highlighted that AI could help forecast HTA agency decisions and streamline tasks like literature reviews and submissions. However, its use in HTA remains limited due to strict transparency demands, the need for explainability and human oversight, and the sensitive nature of PRMA documentation, especially in critical negotiations. The author concludes that while AI has transformative potential, its adoption should be gradual and supported by close collaboration among stakeholders. Broader use will depend on robust evidence of performance and cost-effectiveness compared to traditional methods.

On May 27, 2025, a new version of the Nomenclature of Medical Biology Procedures (NABM 97) was released. Changes concerned the introduction of a new code and modifications to the descriptions and wording of several existing codes.

On June 2, 2025, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Godard et al. assessed the carbon footprint of a French nuclear medicine department by comprehensively analyzing both direct and indirect greenhouse gas emissions from diagnostic and therapeutic activities. The study found that, in 2022, total emissions reached 772 tons of CO2 equivalent, with patient and staff transport accounting for the majority (67%) of emissions, followed by procurement and energy use. These findings highlight that indirect emissions constitute the primary environmental burden in tertiary healthcare settings.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Fleurence et al. introduced a structured taxonomy of generative AI in health economics and outcomes research (HEOR). The authors explore foundational concepts and map emerging applications across domains such as economic modeling, real-world evidence, and dossier development. Key methodological tools - including prompt engineering, retrieval-augmented generation, domain-specific models, and model fine-tuning - are discussed as means to enhance performance and reliability. While the transformative potential of generative AI in HEOR is recognized, the study highlights ongoing challenges around bias, reproducibility, and practical implementation. The report calls for deeper integration of HEOR expertise into AI development to leverage these technologies in health decision-making responsibly.

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, Gehder et al. conducted a mixed methods study in Germany analyzing the use of the patient-relevant structural and procedural improvement (pSVV) pathway for Digital Health Applications (DiGAs). Their analysis showed that only 20% of DiGAs utilized the pSVV pathway, largely due to a preference for established medical benefit endpoints and challenging regulatory barriers. The study highlights the importance of clearer frameworks, secure processes, and proactive innovation management to support the effective implementation of patient-centered digital health solutions.

In late May 2025, the Innovation Committee of the Federal Joint Committee (G-BA) published decisions recommending the transfer of several completed healthcare research and new forms of care projects into standard care. These projects addressed a range of topics, including a web-based self-help program for relatives of individuals with depressive disorders, strengthening crisis resilience in outpatient medical practices, and structured aftercare following bariatric surgery.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Fernandez et al. conducted a cross-European survey of Health Technology Assessment (HTA) bodies to map organizational diversity and assess progress toward harmonization. Their findings reveal substantial variation in agency structures and processes, but also a strong move toward collaboration, which is expected to accelerate with the implementation of the EU HTA Regulation in 2025. These developments are anticipated to drive mutual learning and more efficient technology adoption, ultimately benefiting patients across Europe.

The French National Authority for Health (HAS) released new recommendations regarding the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) following the May 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). One favourable opinion was issued concerning add-on reimbursement for medical device in the men’s health field.