As an increasing number of digital health technologies are released in areas ranging from biosensors and genomic sequencing to telemedicine and mobile health apps, evaluating the clinical and financial impact of such tools is crucial to ensure that the market does not become oversaturated with low value products. These technologies have potential to address mounting challenges of the U.S. healthcare system that traditional models and processes have not improved, and, consequently, are attracting the interest of several government organizations due to positive marketing claims. But do these product claims hold under the scrutiny of randomized clinical trials and peer-reviewed research?
A cross-sectional, observational analysis was recently conducted on peer-reviewed publications from the top twenty digital health companies spanning twelve different health sectors. The purpose of this paper was to (1) determine whether top-funded digital health companies measure the impact of their products and/or services in terms of outcomes, cost, and access to care and (2) analyze the extent to which these products and/or services are studied in high-burden populations. In this context, a high-burden population refers to patients with the top five conditions or risk factors according to cost, years of life lost, or disability adjusted life-years (DALYs). The aforementioned companies were selected based on total amount of private equity funding - with a median of $67.5 million - given the assumption that these businesses were most financially equipped to execute and publish studies that demonstrated the impact of their technologies. A total of 104 PubMed studies were identified for evaluation, and the results were as follows:
- 15% of studies assessed clinical effectiveness of digital health products, all of measured impact in terms of patient outcomes only (i.e. not cost or access to care).
- 28% of studies targeted patients with high-burden conditions or risk factors, with the largest areas being mental health, diabetes, cancer, hypertension, and depression.
- 8% of studies evaluated clinical effectiveness of digital health products and/or services in a high-burden population.
With relatively few peer-reviewed studies analyzing the effect of digital health products and/or services in patients with high-burden conditions, it can deduced that these technologies have had limited impact on disease burden and cost in the U.S. healthcare system. Papers published by the top 20 digital health companies focused on (1) potential of technology (2) technical validation and (3) reports of use among consumers with no studies assessing cost reduction or improvement in access to clinical care. Of the few studies that did evaluate product and/or service effects on clinical outcomes, a majority enrolled non-high-burden participants i.e. healthy volunteers sought to validate the technology’s marketing claims. Still, even amongst this targeted group, none of these studies were able to demonstrate disease prevention in these healthy populations. These findings illustrate the importance of fostering an environment that encourages digital health companies to create products and/or services that are evidence-based and ultimately improve the value of patient care. Policy makers can begin to build this environment by focusing on the following two areas:
AREA ONE: Regulatory requirement clarifications on all types digital health technologies.
ISSUE: Low number of studies in high-burden condition populations due to use of direct-to-healthy consumer products which are less tightly regulated.
HOW TO ADDRESS: FDA regulation currently differs between healthy consumer products versus those marketed to disease-bearing patients. The creation of federal guidelines that ensure all digital health products undergo comparable regulation and approval processes to ensure safety and validity would minimize this issue.
AREA TWO: Incentive developments to strengthen customer market.
ISSUE: Low number of studies addressing digital health product and/or service impact on metrics, specifically outcomes, cost, and care access.
HOW TO ADDRESS: The customer market for high-burden condition products is much more challenging to access in comparison to wellness products that use direct-to-consumer approaches. However, a shift towards value-based care model would result in a higher demand for digital health tools with evidence-based value. Both providers and patients could be encouraged to utilize such tools in their practice and health maintenance, respectively, via financial incentives and reimbursement by private insurers.