As the cost of delivering healthcare and developing effective and safe drugs skyrockets, healthcare management companies and payers are striving to invent new ways to improve patient access and treatment outcomes. Historically, pharmaceutical, surgical, and in-person behavioral interventions have been the primary treatment methods. Technology has gradually gained a foothold in healthcare by automating office tasks through electronic medical records and improved diagnosis with medical devices and imaging. However, it has largely remained untapped as a treatment tool. With innovations in hardware and software platforms and devices, unprecedented increase in computational and analytical capabilities, and access to data, digital solutions are now being explored to improve individual and population health. A reduced cost to experiment, invent and test digital healthcare interventions, specifically prescription digital therapeutics (DTx), is poised to create accelerated growth.
Most of us own or are familiar with smartphones and wearable devices, and access websites for knowledge and entertainment. Numerous apps provide support for weight loss, therapeutic diets, and physical activities. However, very few apps have been tested to ensure that the intervention and support they give help the end-user. Fewer still have undergone rigorous clinical trials to prove their effectiveness. It is this crowded, unregulated landscape that led to a new breed of digital interventions. A digital therapeutic is an “evidence-based therapeutic intervention to patients that is driven by software to prevent, manage, or treat a medical disorder or disease. It is used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes” [i].
DTx can be used as a digital intervention to modify patient behavior and achieve a clinical outcome or as an adjunct to traditional treatment modalities. The most exciting use of DTxs is its potential as a drug replacement, as in Pear’s reSET [ii]. Consequently, investments in digital-therapeutics companies in the US have grown by an average of 40% per year over the past seven years to reach more than $1 billion in 2018 [iii].
Like pharmaceuticals, digital therapeutics must also go through the regulatory and approval processes of the FDA. With the establishment of the Digital Health Center of Excellence in 2020 [iv], the FDA can scrutinize and approve DTx. Given the complex nature of software, the FDA’s Digital Health Software Precertification (Pre-Cert) Program [v], offers a pilot for efficiently approving software-based medical devices. Considering the pandemic, the FDA has temporarily removed some of the regulatory barriers for low-risk technology solutions. This will likely spur more growth in the DTx sector and bring safe and effective digital treatments to the public.
Healthcare organizations and tech giants are combining their patient care management expertise with data analysis capabilities to forge a new healthcare infrastructure. Aided by artificial intelligence, we may have “medical Alexas®” diagnosing health conditions with voice commands and “Okay, Google!” recording and cataloging doctor-patient conversations to send to patient’s smartphones. These technological innovations create opportunities for cost savings in the form of reduced ER visits, enhanced screening, diagnostics, and chronic disease management. However, adopting digital interventions into existing workflows in physicians’ practices and questions about insurance coverage are significant challenges that need to be addressed.
The US is dealing with an overburdened healthcare system with rising costs. Given the ubiquitous use of digital technologies, digital therapeutics are a promising solution to promote behavior change and improve patient health outcomes at a large scale.
[i] Home – Digital Therapeutics Alliance. (2021, January 24). Digital Therapeutics Alliance. https://dtxalliance.org/
[ii] PEAR Obtains FDA Clearance of the First Prescription Digital Therapeutic to Treat Disease – Pear Therapeutics. (2017, September 14). Pear Therapeutics. https://peartherapeutics.com/fda-obtains-fda-clearance-first-prescription-digital-therapeutic-treat-disease/
[iii] Hackett, A., Hung, A., Olivier Leclerc, & Sri Velamoor. (2020, March 31). The promise of digital therapeutics. McKinsey & Company; McKinsey & Company. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-promise-of-digital-therapeutics
[iv] Center for Devices and Radiological Health. (2021). Digital Health Center of Excellence. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/digital-health-center-excellence
[v] Center for Devices and Radiological Health. (2021). Digital Health Software Precertification (Pre-Cert) Program. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program