Digital Health Startups Lack Clinical Credibility, Half Not Reliable

This illustration photo taken in Los Angeles on April 6, 2021 shows a person looking at the app for the New York State Excelsior Pass, which provides digital proof of a COVID-19 vaccination, in front of a screen showing the New York skyline. (Chris Delmas/AFP via Getty Images)

A study on American-based digital health start-ups has found that nearly half—44 percent—of digital health startups lack credibility clinically, with a general lack of robustness in clinical findings.

“Many venture-backed startups in digital health have limited clinical robustness (reliability),” the authors wrote in the study.

The authors examined 224 startups that have received at least one round of investments costing $2 million or more, with an average age of 7.7 years. Altogether, the companies assessed have raised $8.2 billion in venture capital funding since 2011.

Of the 224 startups, 98 of them had a “clinical robustness” score of 0 out of 10.

Further, 15 percent of companies made clinical claims of benefits despite having no clinical credibility at all.

While around 20 percent of the companies had a score of 5 or higher, indicating acceptable reliability of the clinical benefits, the average score altogether was 2.5 out of 10, a significantly low score for digital health software.

The findings all highlight a concerning reality of the disconnect between the market and scientific evidence.

Growing Market With Low Scientific Backing

Digital health is currently projected to be a very profitable market, with a forecasted growth of 17.9 percent from 2021 to 2030. Though the business prospects are bright, evidence of actual clinical benefits has been scant.

The technology is a wide-encompassing market, with direct input in diagnosis, treatment, and prevention. It has a growing clientele among average consumers, healthcare, and insurance providers as well as healthcare employers.

The technology has entered healthcare systems to monitor patient records and make diagnoses for potential health conditions, as well as wearable detectors that monitor health metrics to prevent disease.

The study assessed digital health software spanning three phases of the healthcare continuum; prevention, diagnosis, and treatment, and found that diagnosis systems typically have greater reliability, with a score of 2.8 in clinical robustness, followed by 2.2 for treatment, and then 1.9 for prevention.

The current research indicates that many new digital health providers can be unreliable and misinformative.

The authors wrote that the findings pose “a significant opportunity for companies to differentiate themselves and for customers to demand greater validation for the products and services they purchase.”

Previous studies have also indicated the unreliability of digital health products, creating barriers to the uptake of these products.

Further, many digital health systems have also been caught stealing consumer data and eliciting fraud, crippling the growth of this new and profitable sector.

The Federal Trade Commission previously sued Luminosity in 2016 for deceiving its consumers with unfounded claims that the games it had on the app reduced and delayed cognitive impairment. Carrot Neurotechnology’s Ultimeyes was also sued in 2015 for making false claims that the app improved users’ vision.