Clinical Validation of Digital Healthcare Solutions: State of the Art, Challenges and Opportunities.
| Autor: | Gomis-Pastor, Mar, Berdún, Jesús, Borrás-Santos, Alicia, De Dios López, Anna, Fernández-Montells Rama, Beatriz, García-Esquirol, Óscar, Gratacòs, Mònica, Ontiveros Rodríguez, Gerardo D., Pelegrín Cruz, Rebeca, Real, Jordi, Bachs i Ferrer, Jordi, Comella, Adrià |
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| Předmět: |
DIGITAL technology
ACCREDITATION CLINICAL medicine SAFETY ART MEDICAL informatics DIFFUSION of innovations NATURE RESEARCH funding INTERPROFESSIONAL relations DATABASE management DIGITAL health EMPIRICAL research EVALUATION of medical care PATIENT care DESCRIPTIVE statistics BUSINESS SYSTEMATIC reviews MEDLINE TELEMEDICINE RESEARCH methodology CONCEPTUAL structures BIBLIOMETRICS QUALITY assurance ONLINE information services DATA analysis software ADOPTION RELIABILITY (Personality trait) |
| Zdroj: | Healthcare (2227-9032); Jun2024, Vol. 12 Issue 11, p1057, 21p |
| Abstrakt: | 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. [ABSTRACT FROM AUTHOR] |
| Databáze: | Complementary Index |
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