44% of Digital Health Companies Have Low Levels of Clinical Robustness

Despite the rapid growth of the digital health sector in recent years, a study published in the Journal of Medical Internet Research found that many digital health companies have low levels of clinical robustness, indicating a need for further clinical validation.

The digital health sector has seen rapid growth over the past decade, particularly during the COVID-19 pandemic. In the first quarter of 2022, digital health funding totaled $6 billion, with an average deal size of $32.8 million, according to data from Rock Health. This figure is extremely high, though it trails the $7.3 billion raised in the fourth quarter of 2021.

Although many assume that increased demand for digital health solutions was accompanied by increased education, researchers found that many healthcare technology stakeholders do not clearly understand clinical robustness. Thus, they decided to examine the clinical robustness and public claims made by digital health companies.

Researchers collected data from 224 digital health companies using the Rock Health Digital Health Venture Funding Database, the Food and Drug Administration, and the National Library of Medicine. 

The primary unit of measurement researchers used in the cross-sectional observational analysis was the clinical robustness score, calculated as the sum of the number of regulatory findings and clinical trials.

The study shows that the average clinical robustness score was 2.5, that is, 1.8 clinical trials and 0.8 regulatory filings. Around 44 percent of companies had a score of 0, and 20 percent had a score of 5 or more.

Regarding public claims, the average number was 1.3, with 0.5 being clinical, 0.4 being economic, and 0.4 being engagement-related claims.

Researchers reported no relationship between clinical claims and clinical robustness.

Based on the data collected, researchers concluded that many digital health companies do not have a high level of clinical robustness, indicating that improved clinical validation is needed.

But there are several limitations to the study, mainly relating to the data used in determining clinical robustness and how it required companies to report clinical trials and regulatory findings. Also, the companies included in the study all exceeded $2 million in funding.

In addition to this research, other recent studies have indicated a lack of readiness regarding a complete digital transformation in healthcare.

In April, a report by Morning Consult commissioned by Innovaccer showed that many healthcare executives intend to bring digital transformation to their businesses. However, most of them reported a lack of data readiness standing in the way of necessary changes.

The barriers to digital transformation result from a fear of modernization and commitment, an expert told HealthITSecurity in an interview. Further, digital healthcare involves heavy use of legacy systems, which may pose security concerns due to portability and necessary updating processes.