Assessment practices; European union; European Union countries; Evidence-based; Health technology assessments; Healthcare systems; matrix; Medical device evaluation; Medical Devices; Task force; Medicine (miscellaneous); Health Informatics; Computer Science Applications; Health Information Management
Abstract :
[en] A uniform and harmonised taxonomy of Digital Medical Devices (DMDs) and their evidence-based evaluation are essential to ensure their integration into healthcare systems across the European Union (EU). As part of the Taskforce for Harmonised Evaluation of DMDs, a Common European Classification Grid for DMDs (CEUGrid-DMD) associated with an Evidence Matrix is developed. These tools are based on the mapping of existing frameworks, a survey of Health Technology Assessment (HTA) practices, consensus meetings and workshop. The survey was sent to 32 national representatives of HTA bodies from 18 EU countries. Ten HTA bodies from nine countries completed the survey while others could not, in the absence of the effective implementation of a DMD evaluation framework. This work results in the CEUGrid-DMD including four taxonomy categories, associated with an evidence-based matrix. Overall, this first version should help to converge scientific assessments of DMDs in the context of HTA Regulations across the EU.
Disciplines :
Engineering, computing & technology: Multidisciplinary, general & others
Author, co-author :
Boers, Magali; Luxembourg Ministry of Health and Social Security, Luxembourg, Luxembourg
Rochereau, Aude; Mission numérique en santé, Haute Autorité de Santé, Saint-Denis, France
Stuwe, Louisa; Digital Health Delegation, French Ministry of Health, Paris, France
Miguel, Lorena San; KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé, Brussels, Belgium
Klucken, Jochen; Luxembourg Centre for Systems Biomedicine (LCSB) University of Luxembourg, Esch-sur- Alzette, Luxembourg ; Digital Medicine Group, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg
Mezei, Fruzsina; EIT Health France, Paris, France
Fabiano, Jérôme; EIT Health France, Paris, France
Boulet, Sandrine; Inserm, Université Paris Cité, Inria, HeKA, Paris, France
Perchant, Aymeric; Digital Health Delegation, French Ministry of Health, Paris, France
Tarricone, Rosanna; Department of Social and Political Science, Bocconi University, Milan, Italy ; Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy
Petracca, Francesco; Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy
Hoefgen, Barbara; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
Collignon, Corinne; Mission numérique en santé, Haute Autorité de Santé, Saint-Denis, France
Zohar, Sarah; Inserm, Université Paris Cité, Inria, HeKA, Paris, France. sarah.zohar@inserm.fr
European Taskforce for Harmonised Evaluation of Digital Medical Devices (DMDs) (EvalEUDMD)
Geris, Liesbet ; Université de Liège - ULiège > GIGA > GIGA Molecular & Computational Biology - Biomechanics Research Unit
The authors acknowledge the contribution of the EvalEUDMD Taskforce members ( https://eithealth.eu/dmd-taskforce-members/ ) and Vincent Vercamer, as well as the continuous and constructive support of the members of the external advisory group ( https://eithealth.eu/dmd-taskforce-advisory-board/ ). S Zohar\u2019s contribution was supported by a French government grant managed by the Agence Nationale de la Recherche under the France 2030 program, reference ANR-22-PESN-0003 SMATCH. The authors sincerely thank the reviewers for their time, comments, and valuable feedback that helped them further improve the manuscript. The authors have carefully revised their manuscript and have had it edited for English language by a native English speaker to improve the language. The authors would in this regard like also thank Mrs Margaret Galbraith.
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