How to select the right Digital Therapeutic for your Health Plan

Over 80% of people who receive mental health care are prescribed medication — but 75% would prefer a non-drug option.

4 Things to keep in mind when choosing a digital therapeutics partner

Partnering with a digital therapeutic can open up new doors for Health Plans. Digital Therapeutics act as a third modality to mental health care – addressing gaps and needs not currently met with prescriptions or traditional therapy.

Despite 100M+ Americans looking for mental health therapy, fewer than 22% have access to a mental health care profession. Meanwhile, 35% of those seeking treatment will end up with a prescription, primarily through primary care.

Therapy is a proven way to provide care, but it is not scalable and resources are in short supply. Prescriptions are cheap and plentiful, but many can have detrimental side effects and limited long term efficacy. Digital therapeutics can close the gap by providing affordable, guideline recommended care, at scale.

In order to qualify as a digital medicine, just like any other form of medicine that is intended to treat a condition, a SaMD therapeutic has to satisfy a set of rigorous criteria. There is a direct parallel here to the safety and efficacy of pharmaceutical medicines.

Through our work with healthcare systems we have evolved a simple mnemonic that summarizes, and serves as a template for, these criteria.

The WHAT criteria for digital medicine


W: The treatment has to WORK

H: The treatment has to HELP

T: The treatment has to be TRUSTED

How should this be demonstrated?

Treatment efficacy needs to be supported by adequately powered, pre-registered RCT(s) to demonstrate level 1 evidence of change that is attributable to digital medicine.

Statistical superiority of the digital medicine over a control condition is not enough. Trials need to demonstrate clinically meaningful patient benefits that are directly relevant to outcomes  on the condition being treated.

The digital medicine needs to have excellent clinical governance, meet the highest standards of safety and quality assurance, and reflect national and international clinical guideline care.

Sleepio and Daylight as examples

A total of 13 RCTs published in peer-reviewed journals, spanning ~8,000 participants meeting diagnostic screening criteria. 2 meta-analyses of trials data demonstrating effectiveness across demographic groups.

Published studies report clinical best standard outcomes showing large treatment ‘effect sizes’ and meaningful change on primary and secondary patient reported outcomes, and on functional health and QoL.

Positive appraisal by NICE. Inclusion in international clinical guidelines (American College of Physicians, British Association of Psychopharmacology, European Sleep Research Society). Technical compliance through ISO and HITRUST certification. No adverse events reported attributable to the digital therapy.

Learn how medication targeting can help your population

To discuss how Big Health can help you ensure that your employees have access to safe and effective non-drug treatments for mental health conditions, please fill out the form below.

Disclaimer: In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with insomnia disorder or generalized anxiety disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for insomnia disorder or generalized anxiety disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.