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Title: | Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee | Authors: | Caiani, Enrico G. Kemps , Hareld Hoogendoorn, Petra Asteggiano, Riccardo Bohm, Allan Borregaard, Britt Boriani, Giuseppe Brunner La Rocca, Hans-Peter Casado-Arroyo, Ruben Castelletti, Silvia Christodorescu, Ruxandra Maria Cowie, Martin R. DENDALE, Paul Dunn, Fiona Fraser, Alan G. Lane, Deirdre A. Locati, Emanuela T. Malaczynska-Rajpold, Katarzyna Mersa, Caius O. Neubeck, Lis Parati, Gianfranco Plummer, Chris Rosano, Giuseppe Smirthwaite, Amie SCHERRENBERG, Martijn Szymanski, Piotr |
Issue Date: | 2024 | Publisher: | OXFORD UNIV PRESS | Source: | European heart journal. Digital health, | Status: | Early view | Abstract: | 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. Graphical Abstract | Notes: | Caiani, EG (corresponding author), Politecn Milan, Dept Elect Informat & Bioengn, Pzza L Vinci 32, I-20133 Milan, Italy.; Caiani, EG (corresponding author), San Luca Hosp, IRCCS Ist Auxiol Italiano, Piazzale Brescia 20, I-20149 Milan, Italy. enrico.caiani@polimi.it |
Keywords: | Mobile health;clinical evidence;requirements;assessment;standardization | Document URI: | http://hdl.handle.net/1942/43381 | ISSN: | 2634-3916 | DOI: | 10.1093/ehjdh/ztae042 | ISI #: | 001253418600001 | Rights: | European Society of Cardiology 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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