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By Rotem Shor, Medisafe Chief Technology Officer
With healthcare becoming digital, patients today are more empowered than ever before. In fact, many digital health platforms create greater engagement and drive actions better than many popular social media channels. Patients are taking notice and taking charge of their health thanks to digital means.
Early on, any type of digital connection to healthcare was simply known as digital health, but with greater segmentation and specialization of the technology, new areas of focus have emerged. Digital therapeutics (DTx) is one such category that focuses on evidence-based, software-driven therapeutic interventions to help patients prevent and manage a medical condition. But with a more hyper-focused attention to specific areas, is digital therapeutics creating silos in the industry or crafting more personalized entry points for patients?
Medical App or Medical Device?
Digital Therapeutics (DTx) is a subdivision of digital health, which represents a collection of technologies, products, and services across healthcare and wellness industries. It’s often defined as delivering evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease. They can be used independently or alongside medications, devices, or other therapies to optimize patient care and health outcomes.
But for instances where a digital platform is used alongside a medication, many wonders if digital therapeutics is more medical device or medical app? Currently, the US Food and Drug Administration (USFDA) considers Digital Therapeutics to be mobile medical apps and are exempt from review. It has even pushed to support innovation in the space with a plan to make digital health products more accessible to all patients. As part of this plan, the USFDA has created three categories for digital therapeutics to determine if they qualify for review.
Apart from fitting into the specific categories, the simplest definition is whether a digital platform offers medical analysis, diagnosis, or treatment directly to patients. While there are some gray areas surrounding coaching and tracking of an existing condition, as well as providing access to treatment guidelines, many digital therapeutics may be considered a medical device that the USFDA allows for use with discretion.
Engagement or Gamification
A key element to the success of digital therapeutics is the level of engagement and connectivity to patients. Many apps claim higher levels of engagement than popular social media channels, but are these platforms supporting health engagement or is it simply a gamification of health measures.
In digital health, the primary motivator should always be to help users to become engaged and participate in their own health. The driver is improved health outcomes, the ability to enhance their own lives, and use of the platform to support a healthy and active life. Gamification can be a driver to create initial interest, but platforms often see a short burst that don’t sustain as users are more interested in prizes than the reward of improved health. The best digital therapeutic platforms lead with engaging content, a rewarding user experience, and actionable support that enhances the platform.
DTx platforms have experienced a slower growth in adoption than typical digital health tools, largely due to confusion about its purpose. The market has had difficulty in distinguishing DTx from the more general health and well-being applications, likely due to overlap in USFDA guidelines. With more commonly used and well-known digital health tools from Apple and Google crowding the market, transferring audiences to more specialized platforms that deliver greater guidance and support has been slow to take off in large numbers.
For consumers, it’s tough to separate unknown applications from those with proven therapeutic value or the cache of notable brand names. And while these platforms aim to close the gap on patients’ whole health, the burden of healthcare provider workflows creates an additional barrier to greater adoption. Add to that the requirements from payers for digital health tools to demonstrate better clinical outcomes within a specific time frame, and the US private health insurance market has been slow to adopt digital therapeutics as part of their workflows. Despite the sluggish uptake of DTx, solutions and advancements are happening through collaboration and use by stakeholders, indicating a future with greater DTx involvement.
Primary Care Applications
A major advantage of DTx is that it offers the physicians an option to connect with patients anywhere and anytime, transcending the physical borders of a clinic or a hospital. Thus, primary care physicians can make the most out of the innovations in technology by engaging patients in their health with DTx tools that motivate patients toward better health outcomes.
DTx applications can enable primary care physicians to monitor and track response to the prescribed therapies, thereby aiding to provide personalized treatment. They can also help to
monitor medication adherence and thereby prevent complications. For chronic care patients, digital therapeutics provides constant updates and reassurance for critical measures such as
monitoring blood sugar readings, medication intake, diet, and exercise.
Through advanced connectivity into EHR systems, patient records from DTx can be reviewed by a primary care physician for getting a holistic picture of the patient’s health. Unlike general digital health tools, DTx applications can perform timely interventions, imparting behavioral modifications around insulin levels, dietary needs, missed medications, or heart rate activity. There are also current evaluations underway to explore the use of DTx in early COVID-19 diagnosis and viral load, helping to immediately reduce the spread of the virus.
It is clear that digital therapeutics are here to stay. Pharma companies are investing in this proven pathway to connect with patients and engage users in their health. Its impact on the digital health industry shows there are continued areas of growth, segmentation, and audiences that are seeking engagement and support. And with increasing support from physicians and payers indicates future expansion and greater integration into the overall healthcare system. The projected market valuations show DTx has become an important weapon in the health system arsenal.
About the Author
Rotem Shor is the Chief Technology Officer of Medisafe, the leading digital companion platform that provides personalized treatment support to more than 7MM users. He is an expert in digital medicine applications and works closely with major pharma companies in developing and guiding direct connection to patients via innovative platforms to support improved health and treatment, with customization and guided treatment.