The news: Most digital health startups fail to demonstrate robust clinical evidence for their products, according to a new study published in the Journal of Medical Internet Research (JMIR).
Digging into the data: Each company received a “clinical robustness” score from 0 to 10 based on their FDA filings and registered clinical trials.
Why it matters: The companies in the study have collectively raised $8.2 billion in VC funding and have been around for an average of 7.7 years.
While some newer firms wouldn’t be expected to generate a high clinical evidence score, many companies in this review are well-funded and older.
Breaking down the marketing hype: Researchers also studied how many companies made claims on their websites about their solutions’ clinical, economic, and engagement outcomes.
The problem: The technological advances made in healthcare continue to impress, particularly as better access to care is a huge need. But if digital health companies can’t validate their products’ efficacy, will they impact patient care?
This study isn’t the first to underscore the lack of clinical evidence generated by digital health companies. But investments into health tech entities have soared in recent years, putting the onus on these startups to deliver outcomes.
The bottom line: Digital health startups have an opportunity to distinguish themselves by standing up to the test of clinical rigor and proving that their high valuations are deserved.
Digital therapeutics companies, for example, must demonstrate real-world evidence through randomized controlled trials to get employers and payers to cover their products.