Digital health technologies hold great promise to solve some of the biggest problems in our healthcare system, including achieving higher quality, lower cost, and greater access to care. In the January 2019 issue of Health Affairs, we reported that scant evidence exists demonstrating the clinical impact of twenty top-funded digital health companies. These companies tended not to study the clinical effectiveness of their products in terms of key healthcare metrics like patient outcomes, cost, and access to care.
We found 104 peer-reviewed published studies on the products or services of these companies. The majority of the studies were from three companies. Nine companies had no peer-reviewed publications. Only 28% of the studies targeted patients with high-burden, high-cost conditions or risk factors. Healthy volunteers were the most commonly studied population. Further, 15% of all studies assessed the product’s “clinical effectiveness” and only eight studies assessed clinical effectiveness in a high-cost, high-burden population. The eight clinical effectiveness studies measured impact in terms of patient outcomes, while no studies measured impact in terms of cost or access to care. There were no clinical effectiveness studies in heart disease, COPD, mental health conditions, hyperglycemia, or low back pain. Studies that did not assess clinical effectiveness may have intended to validate the product against a gold standard measurement or report feasibility of use.