Digital health: a path to validation
Open accessAbstract
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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Evidence-supported apps are slow to be made publicly accessible due to research-to-practice translational lags and complex regulatory systems.
“evidence-supported apps are slow to be made publicly accessible due to research-to-practice translational lags and complex regulatory systems (Mathews et al. 2019).”
From Evaluating the quality, safety, and functionality of commonly used smartphone apps for bipolar disorder mood and sleep self-management (2022) · cites this paper as Mathews et al. 2019
The Existing landscape section says digital health technologies generally lack the constraints that slowed traditional medical products, enabling rapid creation and distribution, often without clinical efficacy trials. It acknowledges regulatory ambiguity and a time-consuming healthcare innovation process, but does not say these delay public access to evidence-supported apps; its account of app distribution points the other way. No page number is available in our copy. (LLM, conf=0.85)
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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.
- Venue
- npj Digital Medicine
- Published
- 2019-05-13
- Volume
- 2
- Issue
- 1
- Pages
- 38-38
- ISSN
- 2398-6352 (ISSN-L)
- 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
- 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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