This study used the Rock Health Digital Health Venture Funding Database, maintained by Rock Health, a digital health venture capital and advisory firm. Since 2011, the database has systematically tracked digital health companies in the United States that have received over US $2 million in publicly disclosed funding. During our study period (2011-2023), the database included 2652 digital health companies. The Venture Funding Database has been used as a primary data source in peer-reviewed studies [1,20-22] and is consistently referenced for US digital health funding trends [23-25]. While other venture funding databases (eg, PitchBook, CB Insights, Crunchbase) cover broader sectors or global markets, Rock Health’s focus on digital health and its consistent application of inclusion criteria make it uniquely comprehensive for US digital health companies.

Our study relied on Rock Health’s definition of “digital health companies,” which frames them as “health companies that build and sell technologies—sometimes paired with a service, but only when the technology is, in and of itself, the service” [26]. This definition guided the scope of our sample, and it is broadly consistent with the US Food and Drug Administration’s definition of “digital health technology” as computing platforms, connectivity, software, and sensors applied to health care and related uses [27]. Data are compiled from multiple public sources, including press releases, company websites, Securities and Exchange Commission (SEC) filings, and media reports, and are continuously updated and checked for accuracy. Each company was coded based on its most recent publicly available description at the time of data validation; the database does not systematically capture historical changes in target populations, health domains, or technologies over time.

We conducted a cross-sectional descriptive study of digital health companies pursuing a DTC strategy. The digital health companies in this database serve several customer segments, such as consumers, payers, and employers. Given our interest in digital health companies pursuing a DTC strategy, companies were included in our sample if consumers were their exclusive customer segment. Companies that sell to payers, employers, and other segments either solely or in addition to consumers were excluded from the analytic sample. This resulted in a final sample of 478/2652 (18.0%) digital health companies in the database identified as exclusively pursuing a DTC model as of December 31, 2023.

This unique industry dataset captured various details about the companies, including the year in which they were founded, the year in which they ceased operations (if they did), total funding received from investors, target populations (eg, women, older adults), clinical indications addressed (eg, mental health, cardiovascular disease), and differentiating technologies used (eg, telemedicine, artificial intelligence [AI] or machine learning [ML]). To ensure data accuracy and verify the companies’ operational status and the clinical indications they addressed, we conducted a thorough review of the 478 companies in our sample. First, this verification process involved cross-referencing company information with websites and public records to confirm operational status and offerings. Second, discrepancies were reviewed and reconciled by members of the research team.

About half of the companies in our sample were not tagged with a clinical indication as their product or service was not tied to a particular disease or symptom but was rather related to fitness, nutrition, or another nonclinical area. The product or service could also relate to a specific group of people with health needs (eg, older adults with fall risk). Thus, we created a new variable called “health domain” that was broader in scope than clinical indication and referred to an area of health or health care needs that a company aimed to address through its product or service. A company’s health domain denoted the clinical indication, nonclinical indication (eg, fitness), or health needs served by the company’s product or service.

Companies were not limited to a single category for target population, differentiating technology, or health domain. For example, a company could simultaneously serve older adults and lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals; use both AI or ML and wearable technologies; and address multiple health domains such as fall prevention and cardiovascular disease. Therefore, the reported frequencies reflect overlaps across categories.

We conducted descriptive analyses of the DTC digital health companies to examine distributions and trends by company characteristics (eg, target populations, health domains, technologies used). This included summary statistics for continuous variables, such as total venture capital funding, as well as frequency distributions for company status, health domains, differentiating technologies, and target populations. We used the median and IQR to describe the center and spread of our data as the data were not normally distributed. Multimedia Appendix 1 describes all the variables in our dataset and how they were defined. We followed the Strengthening the Reporting of Observational Studies in Epidemiology reporting guidelines [28].

This study involved secondary analysis of the Rock Health Digital Health Venture Funding Database, which contains company-level information collected from public sources. This study was determined to not meet the definition of human subjects research by the University of California, Los Angeles, Institutional Review Board. As the dataset contained no data on human participants, informed consent was not applicable. Privacy and confidentiality considerations were also not applicable as all records were at the company level and contained no personally identifiable or protected health information. No participants were recruited or compensated. Access to the Rock Health Digital Health Venture Funding Database was obtained through a formal data use agreement, which granted permission to use the data for academic research purposes.

Using digital health funding data, we found that the number of DTC digital health companies grew steadily between 2011 and 2023. The number of companies targeting specific populations also increased, especially those focusing on women’s health. In contrast, companies serving low-income, rural populations received considerably lower average funding, perhaps due to barriers such as limited broadband access [29] or lower out-of-pocket spending capacity. Throughout the study period, 6.9% (33/478) of the companies ceased operations, with nearly half (14/33, 42.4%) of those closures occurring in 2023. This clustering in 2023 may point to post-pandemic market corrections in digital health funding or shifts in consumer demand. Taken together, these findings illustrate how industry dynamics (eg, funding flows, consumer demand, company survival) shape the availability of DTC digital health and suggest areas where future policy attention could play a role in shaping equitable access, such as improving broadband coverage in rural and other underserved areas.

The prominence of mental health products and services among companies focused on children and adolescents indicates a responsiveness to the present-day youth mental health crisis [30]. The range of health domains addressed among DTC digital health companies revealed variation in focus, likely driven by the specific needs and demands of each population segment as well as market considerations such as total addressable market, payment models, and the perceived likelihood of attracting investment. While DTC digital health companies are interested in satisfying children’s and young adults’ unmet needs, this raises new questions about the requisite level of parental or guardian involvement in these services [31]. Specific policies may be needed to define the appropriate level of parent or guardian involvement to ensure access with safeguards to protect youth.

Nearly one-fifth of DTC digital health companies (93/478, 19.5%) used wearables and biosensors, and 13.2% (63/478) applied AI or ML, which are technologies that may support real-time monitoring and personalization. However, the collection and sharing of consumer-generated health data also raise privacy concerns, particularly in areas such as reproductive health where data misuse could lead to discrimination or legal consequences [32]. Our findings underscore the importance of monitoring how DTC digital health companies address consumer data sharing concerns [33] and whether they proactively address gaps in privacy protections without waiting for consumer health data regulations to catch up.

Future research could extend this work by examining how the strategies of specific kinds of DTC digital health companies evolve over time, as well as comparisons between companies that exclusively pursue a DTC strategy (ie, companies in our sample) and those that also serve other customer segments such as payers and employers. In addition, assessing the relationship between company characteristics and their success or survival would provide greater insights into the factors that influence which models endure and which companies cease operations. Further, additional work could assess what proportion of the DTC digital health market is represented by venture-backed start-ups versus established incumbents, particularly as this balance is shifting with increasing entry by large firms [34]; understanding these dynamics will be important for evaluating implications for competition, regulation, and equitable access.

Existing scholarship on DTC digital health has focused on particular kinds of offerings rather than on the sector as a whole. For example, studies on DTC telemedicine platforms have examined issues such as prescribing practices, continuity of care, and regulatory oversight [35]. Similarly, research on mental health apps and fertility-tracking tools has raised concerns about data privacy and effectiveness [36]. While these studies provide important insights into specific domains, less attention has been paid to systematically characterizing the broader DTC digital health landscape across populations, health domains, and differentiating technologies.

Our study differs in scope. Rather than analyzing a single type of offering, we provide a descriptive overview of the DTC digital health sector at large, drawing attention to who companies serve, which health domains they target, and what technologies they used. While our findings echo themes raised in previous domain-specific work (eg, the growth of mental health tools, concerns about equity), they also extend the conversation by situating these developments within the larger structure of the DTC digital health sector. In this way, this paper contributes empirical grounding for ongoing debates about the implications of DTC health for access, equity, and consumer protection.

This study had the following limitations. First, the companies listed in the database were restricted to those that have publicly disclosed investment deals of at least US $2 million and meet Rock Health’s definition of digital health. As a result, the data did not capture major technology companies (eg, Amazon, Apple) [37,38] or pharmaceutical companies (eg, Eli Lilly and Company, Pfizer) [39] that have ventured into DTC health and may underrepresent smaller seed-stage or bootstrapped firms that are part of the DTC digital health ecosystem. Second, as our analysis was limited to companies focusing exclusively on selling to consumers, our findings do not allow for comparisons with companies that offer insurance coverage. This distinction has equity implications as out-of-pocket costs may be a substantial barrier for underserved populations and influence the extent to which these groups can access DTC digital health services. Third, our dataset extended only through 2023. As additional years of data become available, future research could examine whether the trends we identified persist or shift and directly compare post-2023 developments with our findings.

The DTC digital health market, now over a decade old, has reached an inflection point for assessing the needs it is fulfilling and who it is serving. Our findings provide a descriptive account of the well-established areas of DTC digital health. As individuals continue to receive care in DTC digital health settings outside of traditional health systems, it will be increasingly important to evaluate whether these offerings indeed improve outcomes and lower costs.