JMIR Publications

ABSTRACT

Background:

The digital health sector has experienced rapid growth over the past decade. However, healthcare 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 U.S. Food & Drug Administration, and the U.S. National Library of Medicine. Clinical robustness was defined using regulatory filings and clinical trials completed by each company. Public claims data included clinical, economic, and engagement claims made by each company on its website.

Results:

A total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) of all companies had a clinical robustness score of 0, while forty-five (20%) of companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r-squared = 0.02), clinical robustness and total funding (r-squared = 0.08), or clinical robustness and company age (r-squared = 0.18).

Conclusions:

Many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online respectively. Companies and customers may benefit from investing in greater clinical validation efforts.