Assessing the clinical robustness of digital health startups

"With special thanks to co-author Simon C. Mathews, MD, and researchers Veeraj Shah and Shannon Powelson.
By many measures, digital health has boomed across the past decade—so what clinical impact is there to show for it? It’s often difficult to quantify the outcomes of the digital health industry at large because most companies are still privately held and there are no universal standards for outcomes. This challenge leaves innovators, enterprises, and investors alike trying to understand whether impact matches the hype.
To shed light on this question, we analyzed the clinical trials, regulatory filings, and claims (clinical, economic, and engagement) made by clinically-focused startups1 to see if there are clear patterns.
The short answer: robust clinical evidence is not evenly distributed across digital health. Of the companies we looked at, we found that a sizable minority of those companies (20%) represented an outsized share of the trials and regulatory filings. Additionally, claims are not well correlated with evidence—startups that make more clinical claims are not always those with more trials or regulatory filings. Across the board, average numbers of clinical, economic, and engagement claims are low.
We recently published these results in JMIR—you can check out the full paper here. Read on for the key takeaways.
How we assessed claims and clinical robustness2
Our analysis included the 224 companies offering prevention, diagnosis, or treatment solutions—those that we would expect to have clinical evidence—in Rock Health’s Venture Funding Database3. We examined two key variables for each company..." Lire la suite