COVID-19 Guidelines Lay the Foundation for an Expanding Digital Health Market

With the world adapting to remote working and online learning, digital therapeutics (DTx) are positioned to improve patient care now more than ever. Personal Connected Health Alliance (PCHAlliance) has partnered with the Digital Therapeutics Alliance (DTA) to define and further establish the field of digital therapeutics. PCH Alliance contributes the infrastructure, reach and resources with the expertise, focus, and leadership of DTA through a strategic partnership. PCHAlliance also launched a Digital Therapeutics Task Force, which will focus on high priority projects for both organizations.

The term digital therapeutics refers to software programs designed to deliver patient care to prevent, manage, and treat a wide range of diseases, with their key focus on delivering clinical . DTx are a distinct, independent category of digital health products. Not all technology related healthcare products qualify as digital therapeutic products. For a product to be approved by the FDA as a digital therapeutic product, it must display either clinical evidence, proven outcomes, or direct therapeutic interventions. Products such as online patient portals, pill box dispensers with electronic alerts, or fitness trackers do not qualify as digital therapeutic products. Each digital therapeutic product falls under one of four categories based on its intended use:

  1. Address a medical condition
  2. Manage or prevent a medical disorder
  3. Treat a medical disorder
  4. Optimize medication

DTx products offer an opportunity for patients to personalize their health care and address any potential unmet needs they may have.

Patients can use digital therapeutic technology conveniently at home through mobile apps. This remote access creates new opportunities for patients to obtain health-related services that may have otherwise been unattainable. Digital therapeutic software systems can be used independently or in combination with other therapies. DTx offer a variety of health services, including general counseling and information, cognitive behavioral therapy, synchronization of DTx apps to medical equipment, and addressing chronic conditions in conjunction with a drug regimen. Through the utilization of DTx, patients and providers gain insight into patient response through safe, effective, and reliable tools and guidance.

Telehealth is on the rise as patients seek safe and preventative measures to stop the spread of COVID-19. Digital therapeutics make up just one of the many digital health categories experiencing expansion during the pandemic. Millions of Americans have sought care by connecting virtually with their providers, possibly for the first time ever. The “Coronavirus Preparedness and Response Supplemental Appropriations Act”, instituted on March 6, 2020, loosened existing telehealth restrictions to enhance patient access to these services. Although the increased utilization of telehealth has provided convenient alternatives to traditional healthcare during the COVID-19 pandemic, areas of concern remain for telehealth. Some of these areas include prescriber training, billing and reimbursement, and patient skepticism. How are you using or preparing for digital therapeutics and telehealth?


To find more information on the topic:

To look at updates regarding the “Coronavirus Preparedness and Response Supplemental Appropriations Act:

PHSL Previous Blog:

Digital Therapeutics & The Role of the Pharmacist presented at ASAP by Ann Johnson


Posted: June 2020

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