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Digital health: a path to validation

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.

 

Digital-health-a-path-to-validation

 

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Acknowledgements

The authors thank Roger Park for his input on the financial industry. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Author information

All authors meet the four criteria detailed in Author Instructions. The author (S.C.M.) was responsible for concept and design, analysis and interpretation of data, creation of figures and tables, drafting and revision of the paper, final approval, and accountability for the work. M.J.M., C.L.H., A.R., A.B.L., and A.B.C. were responsible for elements of design and analysis and interpretation of data, creation of figures and tables, drafting and revision of the paper, final approval, and accountability for the work.

Correspondence to Simon C. Mathews.

 

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