«When it comes to digital health products, accountability matters. The astounding growth in digital health care technology in the past decade may have come at the cost of startups being sure that the products and services actually do what they purport to do. Researchers from Rock Health, the Cambridge University Department of Public Health and Primary Care, and Johns Hopkins University’s Whiting School of Engineering and School of Medicine published a cross-sectional observational analysis of 224 digital health companies. Less-than-heartening study results found that many of the analyzed companies had low levels of clinical robustness. Because a significant number of digital health companies made few claims for their products, the research team concluded that health care technology developers do not fully understand the importance of clinical robustness and claims.»
«The researchers analyzed U.S. digital health startup companies with at least one round of funding from 2011 to 2020 that sell products for health care prevention, diagnosis, or treatment. To tally a digital health company’s claims, the researchers looked for “unique quantitative statements about product outcomes” on the company website, including links to external pages. Claims factors included engagement (such as number of users), economic matters (such as money saved or cost savings), and clinical impacts (such as diagnostic efficacy or disease reversal or cure), The team measured clinical robustness by summing company regulatory filings and clinical trials.»
Article written by Bruce Brown.