Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis
Sean Day1, Veeraj Shah1,2, Sari Kaganoff1
1Rock Health Inc, San Francisco, CA, United States.
Journal of Medical Internet Research
|June 20, 2022
Summary
Digital health companies often lack clinical robustness and verifiable claims. Investing in clinical validation is crucial for both companies and consumers to ensure product efficacy and safety in this rapidly growing sector.
Area of Science:
- Digital Health
- Health Technology Assessment
- Clinical Validation
Background:
- The digital health sector has seen significant expansion.
- Stakeholders in health care technology require a clearer understanding of clinical robustness and industry claims.
Purpose of the Study:
- To analyze the clinical robustness of digital health companies.
- To evaluate the public claims made by digital health companies regarding their products.
Main Methods:
- A cross-sectional observational analysis of 224 digital health companies.
- Clinical robustness was assessed via regulatory filings and clinical trials.
- Public claims (clinical, economic, engagement) were collected from company websites.
Main Results:
- The average clinical robustness score was 2.5, with 44% of companies having a score of 0.
- The average number of public claims per company was 1.3.
- No significant correlation was found between clinical robustness and clinical claims, funding, or company age.
Conclusions:
- Many digital health companies exhibit low clinical robustness and limited public claims.
- Increased investment in clinical validation is recommended for digital health companies and their customers.
Keywords:
digital healthhealth techreal-world evidencesoftware as a medical device (SaaMD)venture capitalMore Related Videos
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