The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity.
Digital health
Guidelines
Health data
Real-Word Data
Real-World Evidence
Wearables
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
23
12
2020
accepted:
26
03
2021
pubmed:
30
4
2021
medline:
30
4
2021
entrez:
29
4
2021
Statut:
ppublish
Résumé
In the new era of healthcare digitalization, there is a golden opportunity in the overlap between digital health and Real-World Evidence (RWE). In this commentary, we define RWE and digital health and investigate their intersection. We describe the stages in the RWE value chain critical to the evidence generation process, how these stages change with new digital technologies and the opportunities and challenges that arise from how these stages evolve-including their application for stakeholders such as patients, physicians and regulators. We also discuss the current published guidelines and frameworks regarding digital health. We categorise these publications in terms of their clarity as "Extensive", "Intermediate" or "Basic" and according to whether they encompass all levels of digital health or are more focussed in their guidance. Finally, we provide recommendations to increase synergy between RWE and digital health.
Identifiants
pubmed: 33914297
doi: 10.1007/s43441-021-00288-7
pii: 10.1007/s43441-021-00288-7
pmc: PMC8082742
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
889-898Références
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