ArticleEuropean heart journal. Digital health2024
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).
Article in European heart journal. Digital health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Feasibility of the Aktivplan Digital Health Intervention for Supporting Regular Physical Activity Following Phase II Rehabilitation: Randomized Controlled Pilot Feasibility Study (ACTIVE-CaRe Pilot).JMIR formative research · 2026Trial
- Individually tailored monitoring at home after hospitalization for HEART failure (IT-HEART): design and baseline characteristics of a randomized clinical trial.Heart failure reviews · 2026Trial
- Rationale and design of the AutoHealth study: prospective clinical validation of continuous multimodal in-vehicle health monitoring in real-world mobility.European heart journal. Digital health · 2026Article
- Wearable devices and cardiovascular health: revolutionizing remote monitoring and disease prevention.European heart journal · 2026Review
- Mobile Interventions for Reducing Sedentary Behavior and Promoting Physical Activity Among Office Workers: Bibliometric Study.Health education & behavior : the official publication of the Society for Public Health Education · 2026Review
- Total product lifecycle regulatory considerations and recommendations for generative AI-enabled medical devices.European heart journal. Digital health · 2026Article
- Considerations for mHealth development: lessons learned from two diabetes education apps.mHealth · 2026Article
- Monitoring Atrial Fibrillation Using Wearable Digital Technologies: The Emerging Role of Smartwatches.Journal of clinical medicine · 2025Review
- Validity of self-assessment tools for cardiovascular risk behaviors: A systematic review.American journal of preventive cardiology · 2025Review
- Article
- Feasibility of the aktivplan Digital Health Intervention for Regular Physical Activity Following Phase II Rehabilitation: Protocol for a Mixed Method Randomized Controlled Pilot Study (ACTIVE-CaRe Pilot).JMIR research protocols · 2025Article
- EHRA perspective on the digital data revolution in arrhythmia management: insights from the association's annual summit.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Review
- Integrating CEN ISO/TS 82304-2 in the Catalan Health App Assessment Framework: Comparative Case Study.JMIR mHealth and uHealth · 2025Article
- Compatibility of the CEN-ISO/TS 82304-2 Health App Assessment Framework With Catalan and Italian Health Authorities' Needs: Qualitative Interview Study.JMIR formative research · 2025Article
- Testing and Iterative Improvement of the CEN ISO/TS 82304-2 Health App Quality Assessment: Pilot Interrater Reliability Study.JMIR formative research · 2025Article
- A Novel, Non-Invasive AI-Based Telemonitoring System for Heart Failure: Detection of Undiagnosed Hyperthyroidism in an Asymptomatic Patient.European journal of case reports in internal medicine · 2025Article
Corrections and comments
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Authors and funding
26 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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