Just a moment...

Using the Rock Health Digital Database,1 which profiles digital health companies based in the USA that received more than $2 million in publicly disclosed funding from 2011 to 2019, we found that 252 (21%) of 1214 digital health companies pursued a direct-to-consumer strategy.

Although the attractiveness of these products to consumers is clear, direct-to-consumer products bypass the typical filters and safeguards of health-care systems. The risk is that low value, or even harmful, products will inundate the commercial health-care market. There are cautionary instances of high-profile direct-to-consumer companies, such as... See more

These technological offerings can address unmet health-care needs by circumventing traditional intermediaries, such as payers (eg, insurance companies and governments), clinicians, employers, and the pharmaceutical industry, and provide patients with direct access to health-related data and services. Like other industries that empower consumers wit... See more

Direct-to-consumer products that make explicit claims about wellness and lifestyle but imply health benefits for serious medical conditions are particularly concerning. These products easily bypass the current regulatory radar. For example, a fitness product might imply health benefits for patients with cardiovascular disease despite never being te... See more