Digital health technologies (DHTs) at the intersection of health, medical informatics, and business aim to enhance patient care through personalised digital approaches. Ensuring the efficacy and reliability of these innovations demands rigorous clinical validation. A PubMed literature review (January 2006 to July 2023) identified 1250 papers, highlighting growing academic interest. A focused narrative review (January 2018 to July 2023) delved into challenges, highlighting issues such as diverse regulatory landscapes, adoption issues in complex healthcare systems, and a plethora of evaluation frameworks lacking pragmatic guidance. Existing frameworks often omit crucial criteria, neglect empirical evidence, and clinical effectiveness is rarely included as a criterion for DHT quality. The paper underscores the urgency of addressing challenges in accreditation, adoption, business models, and integration to safeguard the quality, efficacy, and safety of DHTs. A pivotal illustration of collaborative efforts to address these challenges is exemplified by the Digital Health Validation Center, dedicated to generating clinical evidence of innovative healthcare technologies and facilitating seamless technology transfer. In conclusion, it is necessary to harmonise evaluation approaches and frameworks, improve regulatory clarity, and commit to collaboration to integrate rigorous clinical validation and empirical evidence throughout the DHT life cycle.

(1) Background: In the mHeart trial, we showed that an eHealth intervention, mHeart, improved heart transplant (HTx) recipients’ adherence to immunosuppressive therapy compared with the standard of care. Herein, we present the analysis assessing whether mHeart reduces complication frequency and healthcare resource use, and whether this reduction depends on patients’ adherence. (2) Methods: The mHeart was a single-center randomized-controlled trial (IIBSP-MHE-2014-55) in 134 adult HTx recipients (n = 71 intervention; n = 63 controls). The endpoints were mortality, complications, and resource use during follow-up (mean 1.6 ± 0.6 years). (3) Results: A significantly lower proportion of HTx recipients in mHeart had echocardiographic alteration (2.8% vs. 13.8%; p = 0.02), cardiovascular events (0.35% vs. 2.4%; p = 0.006), infections (17.2% vs. 56%; p = 0.03), and uncontrolled Hba1c (40.8% vs. 59.6%; p = 0.03) than controls. In addition, a significantly lower proportion of patients in the intervention needed hospital (32.4% vs. 56.9%; p = 0.004) or urgent admissions (16.9% vs. 41.4%; p = 0.002) and emergency room visits (50.7% vs. 69.0%; p = 0.03). Adherence status (measured by the self-reported SMAQ) influenced only controls regarding hospitalizations and emergency room visits. Differences were not significant on deaths (intervention 4.2% vs. control 9.5%; p = 0.4) (4) Conclusions: the mHeart strategy significantly reduced the occurrence of the studied post-transplant complications and the need for medical attention in HTx recipients. Adherence status influenced controls in their need for medical care.

Background/objectives: The growing use of mobile health (mHealth) applications needs reliable tools to assess their usability and user experience in clinical practice to improve the digital health (eHealth) interventions and ensure engagement, as higher engagement is often linked to increased efficacy of healthcare interventions. This study aimed to validate the patient Satisfaction and Usability with APPs questionnaire (pSUAPP), a multidimensional tool designed for the comprehensive assessment of mHealth applications, particularly for the integrated follow-up of patients with chronic diseases. Methods: A validation study was conducted between August and December 2022 with 85 participants from two hospitals in Spain, who completed the pSUAPP questionnaire, comprising 27 Likert-like items across four dimensions: first contact, registration, features and overall experience, and 1 open question. The questionnaire was validated by a panel of 11 experts and further assessed for psychometric properties. Results: The mean pSUAPP score was 79.0 (SD = 12.0), indicating high usability and positive user experience, with the highest scores in the ‘features’ dimension. The pSUAPP demonstrated moderate correlation with the System Usability Scale (SUS) and high reliability (Cronbach’s alpha and omega t > 0.9). A reproducibility analysis showed negligible changes between repeated measures. Conclusions: The pSUAPP questionnaire was found to be a robust tool for evaluating mHealth app usability and user experience, with potential application across various clinical settings.