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. 2024 Jun 4;5(5):509-523.
doi: 10.1093/ehjdh/ztae042. eCollection 2024 Sep.

Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC)

Enrico G Caiani  1   2 , Hareld Kemps  3   4 , Petra Hoogendoorn  5 , Riccardo Asteggiano  6   7 , Allan Böhm  8   9 , Britt Borregaard  10   11   12 , Giuseppe Boriani  13 , Hans-Peter Brunner La Rocca  14   15 , Ruben Casado-Arroyo  16 , Silvia Castelletti  2 , Ruxandra Maria Christodorescu  17   18 , Martin R Cowie  19 , Paul Dendale  20   21 , Fiona Dunn  22   23 , Alan G Fraser  24 , Deirdre A Lane  25   26 , Emanuela T Locati  27 , Katarzyna Małaczyńska-Rajpold  28   29 , Caius O Merșa  30 , Lis Neubeck  31 , Gianfranco Parati  2   32 , Chris Plummer  33   34 , Giuseppe Rosano  35   36 , Martijn Scherrenberg  21   37 , Amie Smirthwaite  38 , Piotr Szymanski  39   40
Affiliations

Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC)

Enrico G Caiani et al. Eur Heart J Digit Health. .

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.

Keywords: Mobile health; assessment; clinical evidence; requirements; standardization.

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Conflict of interest statement

Conflict of interest: G.B. declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, Boston, Boehringer Ingelheim, Daiichi-Sankyo, Janssen, Sanofi. L.N. reports grants or contracts through her institution from Daiichi Sankyo; under 1000 USD personal honoraria from Pfizer-BMS. A.G.F. reports grant support from the European Union Horizon Europe programme for the CORE MD project (agreement 965246); being the Chairman, Regulatory Affairs Committee, Biomedical Alliance in Europe. F.D. Reports being a task force member for the European Society of Cardiology; support for attending meetings and/or travel by the BSI/TeamNB as a technical specialist; fiduciary role in Team NB as a technical specialist from BSI. A.B. reports Abiomed scientific grant (76445733); royalties or licences from Seerling Ltd; Support for attending meetings and/or travel from Pfizer for the ESC congress 2023; being a member of the Librexia ACS trial steering committee. E.G.C. reports a grant in the form of a <1K€ payment to his institution from the Advisory Board on digital Health of Medtronic USA; honoraria for presentations or educational events (total <10k€) from Servier, Summeet Srl, Dynamicom Education Srl, UVET GBT Spa, Sanofi; support for attending meetings and/or travel from the European Society of Cardiology. R.C. declares personal payments for lectures, presentations, speakers bureaus, manuscript writing or educational events from Boehringer Ingelheim, Servier, Novartis, BerlinChemie, Zentiva, Viatris, Pfizer, Astra Zeneca; support for attending meetings and/or travel from Novartis Berlin-Chemie, Astra Zeneca, Boehringer Ingelheim; participation on a Data Safety Monitoring Board or Advisory Board for Boehringer Ingelheim; receipt of drug samples from Astra Zeneca and Boehringer Ingelheim. D.A.L. declares grants or contracts to her institution from Bristol-Myers Squibb and Pfizer; consulting fees from Bristol-Myers Squibb (BMS) and Boehringer Ingelheim; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, BMS-Pfizer, Boehringer Ingelheim. G.R. declares consulting fees paid to the University no value transfer from Astra Zeneca, Bayer, Boehringer Ingelheim, Vifor, Menarini; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events to the university no value transfer from Astra Zeneca, Bayer, Boehringer Ingelheim, Vifor, Menarini; support for attending meetings and/or travel from Fondazione Menarini, Servier, Astra Zeneca. P.H declares Horizon Europe Label2Enable project payments to the Leiden University Medical center and to be the lead expert of CEN-ISO/TS 82304-2 with no financial ties or royalties for CEN TC251; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events covered by Label2Enable project; payment for expert testimony for the Advanced and Active Living project for project reviews; support for attending meetings and/or travel from, the American Society of Clinical Oncology in 2019 as a patient advocate; being the unpaid initiator and driver of two health apps in oncology (ReMind app and Goings-On app). R.A. reports <100 € of royalties or licences from Springer-Verlag GmbH; a 750 EUR payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from the Univers Formazione SRL Roma; participation on a Data Safety Monitoring Board or Advisory Board of Resilience Trial. H.P.B.LR. declares support for the present manuscript in the form of INTERREG-NWE project NWE702; PASSION-HF grants to his institution; grants or contracts from Dutch Heart Foundation CVON 2018-28, ZONMW IMDI 104022004, Vifor Pharma, and Roche Diagnostics to his institution; consulting fees from Novartis Pharma, Boehringer-Ingelheim, AstraZeneca, Roche Diagnostics, Vifor Pharma to his institution; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events to his institution from Novartis, Roche Diagnostics; payment for expert testimony to his institution from Novartis; being on Committee on pharmacological treatment of the Dutch Society of Cardiology. K.M.R. declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Biosense Webster; support for attending meetings and/or travel to/from the European Heart Rhythm Association; being on the board of the European Heart Rhythm Association. E.T.L. declares a professional personal contract (2019–today) as a Senior Consultant with the IRCCS Policlinico San Donato and a professional personal contract (2003–today) as a Senior Consultant with the Italian National Health System—Lombardy Region, support for attending meetings and/or travel to/from the Japanese Heart Rhythm Society (July 2023). M.R.C. Reports having been the chair of the ESC Digital Health Committee in the period 2018–2022; being employed by AstraZeneca. G.P. declares honorariums for lectures from Omron Health Care and Somnomedics. P.S. declares payment or honorariums for educational events from Novartis and Polpharma. R.C.A. declares payment for lectures made to his institution by Abbot and Boston Scientific. CP declares honorariums for educational cardio-oncology presentations from Amgen and Beigene. P.D., S.C., A.S., C.O.M., B.B., M.S., H.K., declare no conflict of interest for this contribution.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Aspects of mHealth solutions important both from patient's and HCP's point of view.
Figure 2
Figure 2
The CEN-ISO/TS 82304-2 health app quality label, available as multimedia Supplementary material online, Appendix  S3 of.
See this image and copyright information in PMC

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