Publication Digest: What Makes a Quality Health App-Developing a Global Research-Based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: Delphi Study

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, Martin et al. examined three Early Access Programs in France designed to expedite patient access to innovative medical devices. These included Innovation Funding, which has granted temporary coverage to 16 out of 35 applications (46%) since 2015; Transitional Coverage (PECT), which has approved six out of 11 applications (64%) since 2021; and Transitional coverage for digital health applications (PECAN), introduced in 2022, which provided favorable coverage opinion for a telemonitoring solution in its first year. The authors highlighted how targeted funding and regulatory frameworks can bridge the gap between innovation and accessibility, offering valuable insights for the development of a harmonized European framework.

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, Farah et al. conducted a systematic literature review to analyze the suitability of health technology assessment (HTA) domains for AI-based medical devices. The authors highlighted the following key challenges: AI technological evolution timelines, data requirements, complexity and transparency, clinical validation and safety requirements, regulatory and ethical considerations, and economic evaluation. Addressing these barriers through an adapted HTA framework will ensure robust assessments, guide the implementation of AI technologies, and maximize their benefits for patients and 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, Vandenberk et al. examined the global determinants of remote monitoring (RM) utilization in patients with cardiac implantable electronic devices through a survey of clinic personnel from 47 countries. The study revealed significant geographic variability in RM adoption, driven by economic factors, such as gross national income per capita and clinic funding models, along with differences between office-based and hospital-based settings. The authors emphasized the need for targeted efforts by all stakeholders to address disparities and enhance access to RM technologies worldwide.

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.