Clinical Validation of Digital Healthcare Solutions : State of the Art, Challenges and Opportunities
Gomis-Pastor, Mar (Institut de Recerca Sant Pau)
Berdún, Jesús (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Borrás Santos, Alícia (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
De Dios, Anna (Institut de Recerca Sant Pau)
Fernández-Montells Rama, Beatriz (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
García-Esquirol, Òscar (Barcelona Health Hub)
Gratacòs, Mònica (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Ontiveros Rodríguez, Gerardo D. (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Pelegrín Cruz, Rebeca (Institut de Recerca Sant Pau)
Real, Jordi (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Bachs i Ferrer, Jordi (Universitat de Barcelona)
Comella, Adrià (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Universitat Autònoma de Barcelona

Date:	2024
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article de revisió ; recerca ; Versió publicada
Subject:	Adoption challenges ; Clinical validation ; Digital health technologies ; Ehealth ; Empirical evidence ; Evaluation frameworks ; Healthcare digitalisation ; Innovation ; Patient care ; Technology transfer
Published in:	Healthcare, Vol. 12 Núm. 11 (june 2024) , p. 1057, ISSN 2227-9032

DOI: 10.3390/healthcare12111057
PMID: 38891132

21 p, 7.4 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles