Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis.

ABSTRACT:

Background

The digital health sector has experienced rapid growth over the past decade. However, health care technology stakeholders lack a comprehensive understanding of clinical robustness and claims across the industry.

Objective

This analysis aimed to examine the clinical robustness and public claims made by digital health companies.

Methods

A cross-sectional observational analysis was conducted using company data from the Rock Health Digital Health Venture Funding Database, the US Food and Drug Administration, and the US National Library of Medicine. Companies were included if they sell products targeting the prevention, diagnosis, or treatment phases of the care continuum. Clinical robustness was defined using regulatory filings and clinical trials completed by

SUBMITTER: Day S 

PROVIDER: S-EPMC9253972 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature