Cited by 508Mobile Health and mHealth ApplicationsHealth, Technology, Consumer BehaviorArtificial Intelligence in Healthcare and Education

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Digital health: a path to validation

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Mathews, Simon C., McShea, Michael J., Hanley, Casey L., Ravitz, Alan, Labrique, Alain B., Cohen, Adam B.·2019·npj Digital Medicine

DOI 10.1038/s41746-019-0111-3PMC PMC6550273

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Abstract

Digital health solutions continue to grow in both number and capabilities. Despite these advances, the confidence of the various stakeholders — from patients and clinicians to payers, industry and regulators — in medicine remains quite low. As a result, there is a need for objective, transparent, and standards-based evaluation of digital health products that can bring greater clarity to the digital health marketplace. We believe an approach that is guided by end-user requirements and formal assessment across technical, clinical, usability, and cost domains is one possible solution. For digital health solutions to have greater impact, quality and value must be easier to distinguish. To that end, we review the existing landscape and gaps, highlight the evolving responses and approaches, and detail one pragmatic framework that addresses the current limitations in the marketplace with a path toward implementation.

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Fig. 1 Regulatory–Clinical–Technology risk paradigm. Examples of increasingly complex clinical applications of technology and their corresponding regulatory contexts are presented in this figureCC BY · PubMed Central

Fig. 2 Traditional Product Lifecycle with Proposed Digital Health Scorecard Added. A representative depiction of the steps within a traditional product development lifecycle is presented in the top half of the figure. The role of an independent evaluator and its relationship with the broader marketplace and product lifecycle is also presentedCC BY · PubMed Central

Fig. 3 Components of Digital Health Scorecard. The four domains of a digital health scorecard with example considerations are detailed in this figure. Their relationship to an assessment of stakeholder requirements is also presentedCC BY · PubMed Central

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Authors: Mathews, S. C., McShea, M. J., Hanley, C. L., Ravitz, A., Labrique, A. B., & Cohen, A. B.
Affiliations: Johns Hopkins University (US)
Corresponding author: Mathews, Simon C.
ORCID: Mathews, Simon C.
McShea, Michael J.
Hanley, Casey L.
Labrique, Alain B.
Cohen, Adam B.
Venue: npj Digital Medicine
Publisher: Springer Science and Business Media LLC
Published: 2019-05-13
Volume: 2
Issue: 1
Pages: 38-38
ISSN: 2398-6352 (ISSN-L)
DOI: 10.1038/s41746-019-0111-3
PMC: PMC6550273
OpenAlex: W2946661638
Cited by: 508
References: 24
Citations by year: 2026: 52 · 2025: 81 · 2024: 107 · 2023: 85 · 2022: 73 · 2021: 60 · 2020: 44 · 2019: 6
FWCI: 8.41
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0 (tdm)
creativecommons.org/licenses/by/4.0 (vor)
Locations: npj Digital Medicine (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Topics: Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Health Sciences › Health Professions › Health Information Management › Health, Technology, Consumer Behavior
Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
Keywords: digital health, validation framework, end-user needs, clinical evaluation, usability, cost evaluation, standards-based evaluation, stakeholder confidence

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