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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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Titel: Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee
Autoren: 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
Verlagsinformationen: Oxford University Press (OUP)
Publikationsjahr: 2024
Bestand: The University of Liverpool Repository
Beschreibung: 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.
Publikationsart: article in journal/newspaper
Dateibeschreibung: text
Sprache: English
Relation: https://livrepository.liverpool.ac.uk/3183909/1/EHJ-DH-D-24-00011_R2.pdf; Collapse authors list. 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 et al (show 16 more authors) , Christodorescu, Ruxandra Maria, Cowie, Martin R, Dendale, Paul, Dunn, Fiona, Fraser, Alan G, Lane, Deirdre A orcid:0000-0002-5604-9378 , Locati, Emanuela T, Małaczyńska-Rajpold, Katarzyna, Merșa, Caius O, Neubeck, Lis, Parati, Gianfranco, Plummer, Chris, Rosano, Giuseppe, Scherrenberg, Martijn, Smirthwaite, Amie and Szymanski, Piotr (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). pp. 509-523. ISSN 2634-3916, 2634-3916
DOI: 10.1093/ehjdh/ztae042
Verfügbarkeit: https://livrepository.liverpool.ac.uk/3183909/
https://doi.org/10.1093/ehjdh/ztae042
Rights: cc_by_4
Dokumentencode: edsbas.C22C04DA
Datenbank: BASE
Beschreibung
Abstract:<jats:title>Abstract</jats:title> <jats:p>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.</jats:p>
DOI:10.1093/ehjdh/ztae042