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Review
. 2019 May 13:2:38.
doi: 10.1038/s41746-019-0111-3. eCollection 2019.

Digital health: a path to validation

Simon C Mathews  1   2 , Michael J McShea  3 , Casey L Hanley  3 , Alan Ravitz  3 , Alain B Labrique  4 , Adam B Cohen  3   5
Affiliations
Review

Digital health: a path to validation

Simon C Mathews et al. NPJ Digit Med. .

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.

Keywords: Health policy; Technology.

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Conflict of interest statement

Competing interestsThe authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Regulatory–Clinical–Technology risk paradigm. Examples of increasingly complex clinical applications of technology and their corresponding regulatory contexts are presented in this figure
Fig. 2
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 presented
Fig. 3
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 presented
See this image and copyright information in PMC

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