Over the past twenty years, the healthcare industry has leaned into digital transformation. Healthcare providers, health systems, and businesses have started to adopt more and more digital technologies to improve their healthcare operations and broaden care possibilities. Digital health offers the possibility of better access to care, improved patient experience, streamlined network management, increased administrative productivity, new surgical techniques, and more.
In 2021, investment into digital health reached an all time high of $57.2 billion globally. That marks a 79% jump from the previous year.1 The industry is popular, growing fast, and offers huge potential—but there is a less optimistic side. According to Forbes, 98% of digital health startups are doomed to fail.2 Why? Numerous reasons from poor market strategy, poor articulation of value, poor implementation, and poor understanding of the industry. But many fail because they over promise and under deliver. How does the industry better focus on care that delivers what it promises?
To be successful, all care—digital, tech, traditional—needs to prioritize the people receiving care and the efficacy of that care. This means that clinically-validated outcomes should be at the center of designing and selecting digital health solutions.
What are clinically-validated outcomes?
Clinical validation is the process of testing a solution’s effectiveness using clinical standards. Good clinical validation is conducted using modern protocols, independent verification, and experts in the field. Findings of clinical validation are also frequently published in a peer-reviewed journal.
Outcomes are the result of care as shown by the clinical validation. Did the care provide good health outcomes? Bad health outcomes? No change in health outcomes? Population size within the clinical validation is also very important. An individual’s outcomes are important to that individual, but do not necessarily indicate anything statistically relevant about the care they received. If we are using outcomes to make a meaningful statement about the quality of care, then the outcomes should be based on at least a minimally viable sample size.
An appropriate sample size means that results will be statistically significant, which in turn means that the resulting data (in this case the outcome results) are not explainable by chance along. There is no one-size-fits-all sample size. Sample size should be “planned on a justifiable, rational basis.”3
Evidence-based research versus evidence-informed versus clinically-validated
Like clinical validation and clinically-validated outcomes, evidence-based is another way to emphasize that care has been designed with outcomes as a priority. Although they are similar, evidence-based and clinical validation can be used in different ways.
Not everyone draws a distinction between the two phrases evidence-based and evidence-informed. If you do draw a difference between the two, evidence-based means that the solution (i.e., the program, practice, or technology) you’re referring to as evidence-based has been studied in a controlled setting. This means that evidence-based is essentially the same as clinically validated. Evidence-informed means that the solution was developed based on industry research—meaning something else similar in the industry was studied and that evidence was used to create a solution, but the solution itself has not necessarily been studied.
Many people use the phrase evidence-based to mean evidence-informed, and in those instances that use of evidence-based is not the same as clinically-validated. You can always ask for clarification if you’re evaluating a healthcare solution and want to know the depth of analysis used to judge effectiveness.
Our approach to clinical validation within our digitally-enabled EAP
Uprise Health strongly believes in the importance of an evidence-based, clinically-validated approach to care. We have been providing EAP and behavioral health services for over 30 years and have experts at the helm of our strategy, product, and operations teams. Not only do we prioritize expertise and experience, but our digital health solutions are backed by evidence-informed research AND clinical validation.
Our digitally-enabled EAP platform was founded using the approaches of both stepped care and computerized cCBT. Stepped care is supported by over 50 research studies to date, and cCBT is supported by over 100 research studies to date. The original protocol of our platform model was developed by our Chief Strategy Officer, Dr. Jay Spence, who has a Ph.D. in clinical psychology. And the protocol has been clinically-validated by three independent, peer-reviewed studies.
If you’re interested in diving deeper into our evidence-informed research and clinical validation, learn more about our approach to digital mental health care.