Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee
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Le résumé fourni par la source
Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee
- Date Crossref
- 04/06/2024
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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IRCCS Istituto Auxologico Italiano pays non établi dans la noticeÉtablissement de santé
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Politecnico di Milano pays non établi dans la noticeUniversité ou école supérieure
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Radboud University Nijmegen pays non établi dans la noticeUniversité ou école supérieure
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Máxima Medisch Centrum pays non établi dans la noticeÉtablissement de santé
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Eindhoven University of Technology Department of Industrial Design pays non établi dans la noticeUniversité ou école supérieure
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Leiden University Medical Center National eHealth Living Lab pays non établi dans la noticeOrganisme public
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University of Insubria Department of Medicine and Surgery pays non établi dans la noticeUniversité ou école supérieure
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Fondazione Poliambulanza Istituto Ospedaliero pays non établi dans la noticeÉtablissement de santé
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Medirex Group Academy pays non établi dans la noticeOrganisation à but non lucratif
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Comenius University Bratislava pays non établi dans la noticeUniversité ou école supérieure
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University of Southern Denmark Department of Clinical Research pays non établi dans la noticeUniversité ou école supérieure
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Odense University Hospital Department of Cardiac pays non établi dans la noticeOrganisme public
IRCCS Istituto Auxologico Italiano, Politecnico di Milano et Radboud University Nijmegen, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.