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The “W.H.A.T.” Digital Therapeutics Validation Criteria

A framework to help payors and clinicians provide meaningful, measurable impact to members and patients.

A framework to help payors and clinicians provide meaningful, measurable impact to members and patients.

The array of digital therapeutics (DTx) with claims for health benefits continues to grow, which may leave clinicians and payors wondering: How can you tell which ones are safe and effective? This space is in urgent need of a consistent, measurable way to evaluate the efficacy and impact of potential solutions. Three leaders in the digital healthcare space — Dr. Troyen A. Brennan, MD, JD, MPH, Executive Vice President and Chief Medical Officer of CVS Health, in Woonsocket, Rhode Island, Dr. John Torous, MD, MBI, Director of the Division of Digital Psychiatry in the Department of Psychiatry at Beth Israel Deaconess Medical Center at Harvard Medical School, in Boston, Massachusetts, and Professor Colin Espie of Big Health — have developed such a system. The W.H.A.T. Digital Therapeutics Validation Criteria uses an easy-to-recall rubric to help payers and clinicians confidently identify and evaluate which DTx are worth adopting and integrating into existing services.

What does W.H.A.T. stand for?

To set the criteria, Brennan, Torous, and Espie identified the most critical functions a safe and effective digital therapeutic must display. The framework is discussed in depth in Health Affairs Journal, and below we offer a high-level overview.


Simply put: The treatment has to work. More specifically the efficacy of the therapeutic needs to be supported by at least one published randomized control trial (RCT). The trial must report pre-registered primary outcomes in a real-world setting. It’s crucial that the treatment is evidence based, and not just evidence informed; meaning the treatment has to be supported by research on itself, as opposed to research that’s already available on a similar solution.    


The treatment must help. It’s important to note that a requirement for a solution to help is distinct from a requirement to work — a solution that delivers “meaningful improvement on validated clinical endpoints that matter to patients and health care professionals” is very different from simply providing statistical evidence of efficacy. Take certain mental health medications for instance: Generally these are clinically proven to reduce symptoms, but have also been shown to reduce patients’ willingness or ability to access behavioral care, which is longer lasting and poses less risk.


The treatment needs to be accessible — not in just one way, but in two. The DTx should be able to demonstrate engagement and retention among “of representative samples of the target clinical population.” Put more plainly, traditionally underserved populations such as people of color, persons with disabilities, and people who identify as LGBTQ+ should be using and having success with the solution. In addition, the solution needs to be scalable to the entire targeted population. This second element highlights one of the distinct advantages of digital therapeutics, as scaling accessibly represents an unprecedented opportunity to reduce mental health disparities.


The treatment needs to be trusted. Again, there are two components to this criterion. The first demands that patients have trust when it comes to the handling of their personal health information. To much of the public, a digital therapeutics provider will fit into the idea of a  “tech company,” many of which have lost trust among the public — especially when compared with the idea of sharing information with a medical professional. In addition, trust must be present in the form of data privacy, clinical governance, and quality management systems. These systems help ensure compliance and are foundational for overall trust.

Defining W.H.A.T. a safe, effective, and meaningful digital therapeutic solution looks like

The W.H.A.T. criteria are meant to be a minimum threshold for DTx companies to apply themselves to so that they are worth adopting and integrating into services to provide meaningful and measurable impact to their members and patients.

The full article of the proposed W.H.A.T. criteria can be found at Health Affairs.
Based on the article posted in Health Affairs Forefront, Feb 28, 2022

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During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

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