Trust is the Journey to Digital Therapeutic Adoption

With over 300,000 digital health apps available in the various apps stores, how is anyone supposed to know which ones can be trusted to deliver safe and effective care to support patients in their disease journey? 

I was recently part of a panel discussion on this topic with eMHIC, and below are a few of the things I highlighted in that webinar. 

Many healthcare stakeholders, from governments to health systems, clinicians, health insurers, and patients, from around the world have begun to call for and develop various types of accreditation services to evaluate and certify health apps to ensure they meet certain minimum standards for safety and clinical efficacy. This helps ensure that healthcare providers can have confidence in prescribing them, patients can have confidence in using them, and governments, patients, and health insurance companies will see value in paying for them. 

So I have a question: Is all we need for mass adoption of digital therapies is to ensure trust among all stakeholders through accreditation and certification based upon a pre-defined criteria? 

We don’t think so. 

We don’t see trust as a singular event such as certification. We see trust as a journey, with multiple steps that take place over a long time where the app must develop and maintain trust at every step along the way. Here is how it works. 

Step 1: Design & Development - trust starts with designing the digital therapy based upon evidence-based, peer-reviewed science that has been proven over time to deliver safe and effective neurobehavioral therapeutic interventions to address, manage, treat and prevent medical conditions. This requires the design and development to be under a quality management system that ensures that appropriate processes are followed to deliver quality outcomes. 

Step 2: Verification & Validation - this process, part of the quality management system, further ensures trust by providing published evidence of quality. This must also include rigorous clinical trials and testing using digital placebos to demonstrate that the digital therapy delivers clinically and statistically significant improvement in patient medical, physical, and psychological outcomes. 

Step 3: Distribution & Access - the way that the patient gets access to the digital therapy demonstrates trust among various stakeholders and further communicates this trust to the patient. Our products are available through employers, health insurance companies, pharmaceutical firms and physicians, all of whom provide confidence to the patient that the digital therapy can be trusted. 

Step 4: Activation - is the process whereby the patient gets physical access to the digital therapy, through an app store or the web, and begins to use it for the first time. All the steps for downloading, registration, payment must instill confidence that the product is friendly and trustworthy. They must have confidence that their information is held private and confidential through things like HIPAA, GDPR, HITRUST, etc. But since a digital therapy that is only used once will not deliver clinical benefit, you must ensure engagement. 

Step 5: Engagement - this is how we employ game mechanics and principles to get the patient to come back again and again to use the product to deliver the clinical benefit. If patients feel, believe and trust that the product will deliver the benefit, then they are likely to use it again and again. On the other hand, if they feel that the experience is not engaging, then the patient will quickly abandon the product; most digital health apps are used, on average, once, and clearly deliver no value. So every time the patient engages with the product we must ensure continued trust and confidence in the therapy so that they will feel, believe and understand that it is working. 

Step 6: Risk Management - many of the medical conditions that we treat with digital therapies can be used by patients who may experience risky side effects from their disease or other medication they are using. Therefore, the patient must trust the digital therapy to monitor their experience, behaviors, and outcomes to identify potential risks and provide interventions by the app as well as through notifying clinicians and obtaining clinical support in risky situations. 

Step 7: Outcomes - the patient must see that they are feeling better as a result of their digital therapy in order to have enough trust in the product so that they will continue to use it over time to continue to improve over the course of therapy. 

Step 8: Dosing - they need to trust that the dosing is appropriate for the acuity of their condition. The more acute the medical condition the higher the dosing, such as daily dosing, whereas the less acute the condition, the more appropriate to have a maintenance dose where the patient may use the product every other day or as needed. 

So will incorporating all 8 of these steps along the journey ensure commercial success? 

No. These are necessary, but not sufficient, steps for trust and success. 

We frequently do tear-downs of competing digital therapies to see how they work and to measure how they perform on these 8 steps. 

Here is the paradox. When we write up our reviews of these products based upon our tear-down, the description of these different products, on paper, can sound exactly the same despite their differences; they can check all the boxes of trust above; yet one of the digital therapeutic products will succeed commercially in the marketplace, while the other one fails. 

But you might ask, didn’t they test it with patients in their clinical trial and test user experience?

For sure. But getting a couple of hundred patients to use a product you are paying them to use for a few weeks in a clinical trial isn’t the same as getting people to use the product in the wild. It is only in the real world, where you remove all the controls and support of a clinical trial, that you can really test your digital therapy to know if it can scale in the wild. 

Why? 

Now I am going to say something shocking: Making successful software can be much more difficult than making successful drugs or medical devices because an app engages more of the senses and emotions of the patient than more traditional medical products. The wrong color, images, font, wording, order of activities, inappropriate communication with the AI, etc. can all lead to poor patient experience that leads to abandonment of the product, and all of these combine together to weave a complex tapestry to deliver the final patient experience. And these are things that defy simple application, classification, insertion, categorization. This is where artistic design combined with game mechanics and principles make all the difference when it comes to engagement and commercial success. 

We find this as a common phenomenon of digital therapies created in academic environments under grant funding. Such digital therapies are developed by small teams that have limited experience in visual design, software development, game mechanics and game principles; and then they are often tested on small student populations, which don’t represent the more common users in the real world. Our most common user is a middle-aged woman. 

We think that the best thing for academics to do is to build their digital therapies on a platform, like we have developed over the past eight years, that has already demonstrated its efficacy in engaging patients. Our platform was designed in such a way that academic and clinical professionals can create an entire month-long digital therapy in less than a month without needing to have any technical or software programming skills. This enables the academic to deliver novel digital therapies quickly and easily to take them through that clinically testing where all the other variables of trust are delivered and the only variable being tested is the actual clinical and medical efficacy of the novel digital therapy. 

We are all in favor of accreditation and certification to separate the wheat from the chaff by providing some minimum standard of trust. But the successful digital therapy will see trust as a long journey, where they have to earn the trust of the stakeholders, and especially the patient, every single day by following the 8 steps I have outlined above.