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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© 2024 European Society of Cardiology. Published by Oxford University Press on behalf of the European Society of Cardiology. 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.
Author(s): Caiani EG, Kemps H, Hoogendoorn P, Asteggiano R, Bohm A, Borregaard B, Boriani G, Brunner La Rocca H-P, Casado-Arroyo R, Castelletti S, Christodorescu RM, Cowie MR, Dendale P, Dunn F, Fraser AG, Lane DA, Locati ET, Malaczynska-Rajpold K, Mersa CO, Neubeck L, Parati G, Plummer C, Rosano G, Scherrenberg M, Smirthwaite A, Szymanski P
Publication type: Article
Publication status: Published
Journal: European Heart Journal - Digital Health
Year: 2024
Volume: 5
Issue: 5
Pages: 509-523
Print publication date: 01/09/2024
Online publication date: 04/06/2024
Acceptance date: 14/05/2024
Date deposited: 08/10/2024
ISSN (electronic): 2634-3916
Publisher: Oxford University Press
URL: https://doi.org/10.1093/ehjdh/ztae042
DOI: 10.1093/ehjdh/ztae042
Data Access Statement: There are no new data associated with this article.
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