Enrico G Caiani
Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee
Caiani, Enrico G; Kemps, Hareld; Hoogendoorn, Petra; Asteggiano, Riccardo; Böhm, 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; Małaczyńska-Rajpold, Katarzyna; Merșa, Caius O; Neubeck, Lis; Parati, Gianfranco; Plummer, Chris; Rosano, Giuseppe; Scherrenberg, Martijn; Smirthwaite, Amie; Szymanski, Piotr
Authors
Hareld Kemps
Petra Hoogendoorn
Riccardo Asteggiano
Allan Böhm
Britt Borregaard
Giuseppe Boriani
Hans-Peter Brunner La Rocca
Ruben Casado-Arroyo
Silvia Castelletti
Ruxandra Maria Christodorescu
Martin R Cowie
Paul Dendale
Fiona Dunn
Alan G Fraser
Deirdre A Lane
Emanuela T Locati
Katarzyna Małaczyńska-Rajpold
Caius O Merșa
Prof Lis Neubeck L.Neubeck@napier.ac.uk
Professor
Gianfranco Parati
Chris Plummer
Giuseppe Rosano
Martijn Scherrenberg
Amie Smirthwaite
Piotr Szymanski
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.
Citation
Caiani, E. G., Kemps, H., Hoogendoorn, P., Asteggiano, R., Böhm, A., Borregaard, B., Boriani, G., Brunner La Rocca, H.-P., Casado-Arroyo, R., Castelletti, S., Christodorescu, R. M., Cowie, M. R., Dendale, P., Dunn, F., Fraser, A. G., Lane, D. A., Locati, E. T., Małaczyńska-Rajpold, K., Merșa, C. O., Neubeck, L., …Szymanski, P. (2024). Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee. European Heart Journal – Digital Health, 5(5), 509-523. https://doi.org/10.1093/ehjdh/ztae042
Journal Article Type | Article |
---|---|
Acceptance Date | May 14, 2024 |
Online Publication Date | Jun 4, 2024 |
Publication Date | 2024-09 |
Deposit Date | Jun 11, 2024 |
Publicly Available Date | Jun 11, 2024 |
Journal | European Heart Journal - Digital Health |
Print ISSN | 2634-3916 |
Electronic ISSN | 2634-3916 |
Publisher | Oxford University Press |
Peer Reviewed | Peer Reviewed |
Volume | 5 |
Issue | 5 |
Pages | 509-523 |
DOI | https://doi.org/10.1093/ehjdh/ztae042 |
Keywords | mobile health, clinical evidence, requirements, assessment, standardisation |
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Standardised assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee (accepted version)
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Publisher Licence URL
http://creativecommons.org/licenses/by-nc/4.0/
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