An Overview of Digital Therapeutics (DTx) and Relevant Regulation

Digital therapeutics (DTx) provide patients with evidence-based therapeutic solutions that are driven by high-quality software programs. These solutions can prevent, manage, or treat a medical disorder or disease and are used both independently or alongside medications, devices, and other therapies. These products leverage advanced technology to bolster design, clinical evaluation, usability, and data security. What follows in this piece are some highlights of a presentation of DTx principles given at AMCP Nexus 2019.

What Are DTx Solutions?

These therapeutic solutions are reviewed and cleared or approved by regulatory agencies to support product claims regarding efficacy, risk, and therapeutic intention. DTx products, according to the presenters, are a distinct subset of solutions within the broader digital health landscape, which consists of mobile health, health information technology, devices, sensors, wearables, personalized healthcare, and telehealth solutions.

To be formally considered a DTx, a product must adhere to several foundational principles, including prevention, management, or treatment of a medical disorder or disease, incorporation of software, emphasis on patient privacy and security, and presence of clinically relevant evidence supported by reliable research. Digital health products that don’t claim to manage or treat a disease are not subjected to the same standards as DTx. Many products in this category include lifestyle and fitness apps, medication adherence tools, telehealth and telemedicine platforms, and other similar technologies.

The International Medical Device Regulators Forum (IMDRF) allows national regulatory bodies to discuss future directions in medical device regulation. This voluntary group of international medical device regulators works to accelerate globalized medical device regulatory synchronization and collaboration. Members include Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea, and the United States, with the World Health Organization (WHO) as an observer.

Software as Medical Devices

Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes without being part of the device’s hardware. This definition was created by IMDRF and it is being integrated into regulatory frameworks internationally. DTx go through the European qualification and review process in Europe and the Food and Drug Administration (FDA) in the United States.

The presenters referenced several DTx technologies, including reSET, a software app that is prescribed by physicians to treats patients with substance use disorder. Other solutions referenced include Propeller, designed to treat asthmatic patients who are uncontrolled on current therapy and patients with chronic obstructive pulmonary disease (class II-IV). Bluestar and Insuylia, two FDA-approved apps for type 2 diabetes management, and Kaia Health, an FDA-approved app therapy for chronic back pain patients, were among the others mentioned.



Coder, M, Patterson, B, et al. Expanding the Managed Care Professional’s Digital Therapeutics IQ. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.