We increasingly turn to our devices for support in every aspect of our lives, and our health and well-being are no exception.

Tech and healthcare have merged to influence everything, from how and where we seek medical information, to how we track symptoms, to being the actual treatment solution. The term ‘digital therapeutic’ (DTx) was coined over 25 years ago in medical literature to refer to evidence-based behavioural treatments delivered online. However, it was not until 2017 that the FDA approved the first DTx to treat disease and NICE only provided its first guidance for a prescription DTx in May 2022. In contrast to the relatively slow development of prescription DTx that requires clinical evidence and regulatory approval, the number of non-prescription DTx and digital health and well-ness apps has grown exponentially.

With this growth inevitably comes confusion, especially around the definitions of digital health applications. A helpful breakdown from Blue Matter Consulting is as follows:

• Prescription DTx: regulatory approval; product ‘pipeline’ similar to pharma companies (eg, Somryst for chronic insomnia, Pear Therapeutics)
• Non-prescription DTx: regulatory enforcement discretion; company-initiated, peer-reviewed evidence of product (eg, Sleepio for insomnia, Big Health)
• Wellness apps: everything else (eg, Calm for meditation and sleep)

Where definitions become challenging is between non-prescription DTx and wellness apps, especially when both are often marketed directly to consumers or indirectly via employee assistance programmes. How can consumers determine the benefits of apps like Sleepio, Calm or Headspace? Where’s the evidence?

The current communications state of healthtech
As newcomers to healthcare, the companies developing non-prescription DTx and wellness apps typically have different structures and functions compared with ‘conventional’ pharma, or even prescription DTx companies. The focus is on software development and user experience and not medical strategy/evidence. Medical expertise may come in the form of a chief medical officer and scientific advisory boards, but the approach to communications is often tech- or experience-based, particularly for wellness apps. For example, in contrast to the non-prescription DTx Sleepio, which has an evident focus on HCP communications (ie, a distinct website area for healthcare professionals (HCPs) vs a small social media presence of <500 Instagram followers), the reportedly scientifically-backed BetterSleep app targets consumers (ie, emphasis on social media with >64,000 Instagram followers). The challenge with this tech-based, direct-to-consumer approach is cutting through the noise and various claimed benefits of the health and wellness industry to get to meaningful outcomes data. When a consumer searches the Google Play Store for sleep apps, they are likely to be overwhelmed by over 75 options, including heavily-marketed Calm and Headspace. However, less than a third of those apps will have demonstrated evidence to support their claims. How can apps differentiate their high-quality offerings from those that lack evidence and clinical rigour?

Where are the HCP communications in healthtech?
In a survey of over 10,000 respondents from McCann Worldgroup’s Truth Central, 75% of people felt that doctors would play a larger role in helping achieve a sense of wellness in the future. Although non-prescription DTx and wellness apps can be purchased directly by the consumer, healthtech companies should not overlook the influence of an HCP’s recommendation. Healthtech can learn from the consumer dermatology field, which has integrated scientific narratives, clinical evidence and HCP advocacy to bring credibility to over-the-counter skincare products. One example is the brand CeraVe, whose parent company, L’Oréal, has created educational resources for different HCP types and actively communicates with HCPs about its latest science and products. As a result, not only can CeraVe make the claim that it is the ‘#1 dermatologist-recommended skincare brand’, but it is also the second-leading US skincare brand. While some large healthtech companies like Calm are communicating its scientific evidence to businesses, HCPs may still be the missing link for the individual end-users.

Evidenced-based medical communications can deliver HCP engagement
We often look to the tech world for inspiration and innovation, but in the union of healthcare and tech, there are still learnings to glean from pharma and its medical communications partners. If there is a scientific narrative to be told, it needs to be told to all audiences and supported by peer-reviewed evidence. In medical communications, we are experts in translating science to both patients and clinicians for maximal impact on health outcomes. If healthtech companies aspire to be a ‘#1 doctor-recommended app’, they need to activate and mobilise HCPs by credibly communicating their wealth of data and creating compelling medical education that translates into business and patient value.

Sarah Funderburk is SVP, Senior Medical Strategy Director at Caudex

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