Dive Brief:

• Despite the proliferation of digital health tools, there is little evidence demonstrating their impact on disease burden and overall healthcare costs, a new Health Affairs analysis finds.
• The authors looked at the 20 top-funded, private U.S.-based digital health companies to see what products and services they offered, whether there was peer-reviewed evidence and the potential to impact patients with high-burden conditions such as heart disease, diabetes and depression. 
• The most common company type was data analytics, while biosensors got the most funding. But only a few companies had published studies, and those typically involved healthy volunteers. Few looked at outcomes in high-burden populations or impact on access and cost.

Dive Insight:

As the field of digital health companies expands and demand for venture funding grows, scrutiny of which products actually affect health outcomes will also increase. Companies will need to demonstrate results and incorporate difficult populations to make it past the early stages. 

"What we've learned in technology and medicine is if you have a technology that works, physicians support it," James Madara, CEO of the American Medical Association, told Healthcare Dive in an interview last year. "If uptake is terrible or not great, it's not being technophobic, it's the canary in the coal mine reporting a problem with these tools. Those have to evolve to another level."

The Health Affairs analysis included a number of big names in digital health, including Jawbone, Health Catalyst, Privia Health and Welltok. Jawbone, which makes biosensors, was the No. 1 funded company at $591 million.

In all, the 20 companies selected for review conducted 104 studies. Of those, 33 were validation studies, 16 evaluated the digital health product’s clinical effectiveness and 55 were simply noted as "other." Only 16 of the studies assessed the product's impact on outcomes, while none measured the effect on cost or access to care.

Moreover, where studies did enroll high-burden patients, only a handful assessed clinical effectiveness — eight out of 52.

"These data suggest that leading digital health companies have not yet demonstrated substantial impact on disease burden or cost in the US health care system," the authors write. "Our findings indicate the importance of fostering an environment, with regard to policy and the consumer market, that encourages the development of evidence-based, high-impact products."

One way to do this, they say, would be to offer a direct provider adoption financial incentive for organizations that adopt impact-focused products that perform general system-wide functions such as increasing efficiency or improving care coordination. For products and services that are used episodically, payers could reimburse providers for using evidence-driven tools on patients who stood to benefit, or give patients credits for buying them.  

The authors point to CMS reimbursement of remote monitoring tools that create patient-generated data that can be transmitted to clinicians.

"This model emphasizes specific health events that require immediate clinical attention, such as acute deterioration or lack of medication or treatment regimen adherence," the authors write. "Such as reimbursement policy could enable providers to incorporate high-value digital health tools into their practices in a financially sustainable manner and thus create a clearer market of customers for digital health companies that build such products."