Introduction

In 1995, the concept of technology-driven therapeutic care provided to patients beyond traditional setups such as hospitals and clinics was introduced by Dr. Joseph Kvedar.

The term Digital Therapeutic (DTx) was trademarked by Click Therapeutics in 2012, and it was defined three years later by Dr. Cameron Sepah in a peer-reviewed journal article.

In 2015, digital therapeutics was introduced in a peer-reviewed publication by Sepah et al. They defined DTx as “evidence-based behavioural treatments delivered online that can increase accessibility and effectiveness of healthcare” (Sepah, Jiang, and Peters, 2015).

Definition

The Digital Therapeutic Alliance (DTA), a global industry organization, introduced and standardized the definition of DTx in the US and worldwide.

Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.

Conjunction of DTx with Hardware Devices (Medical Devices)

• Biofeedback via a Carbon dioxide gas analyser in panic disorder (Freespira).
• A digital inhaler with built-in sensors for COPD/Asthma (ProAir Digihaler). For example, therapeutic maps use location data every time an asthmatic patient uses their inhaler to help prevent future episodes in that location.
• Applying sensor-based monitoring by connecting a blood glucose meter to an insulin pump via the MySugr app for real-time diabetes management.
• Connection to blood glucose meter via diabetes pump (BlueStar App).

Conjunction of DTx with Consumer Devices

• Wearables (e.g., insomnia app Somnio combined with fitness trackers for sleep tracking).
• Actigraphy Sensor (e.g., Mindpax for activity tracking in bipolar disorder).
• Mobile Phone (video game for paediatric ADHD, EndeavorRx).
• VR-devices (Invirto app for phobic anxiety disorders using VR-glasses).

Essential Components of Digital Therapeutics

• Therapeutic functionality (“active ingredient”): the component that shows a therapeutic effect.
• User interface (“digital excipient”): maximizes efficacy of therapeutic functionality (e.g., virtual assistance, patient reward systems, reminders, physician communication).
• Educational component: provides scientific content based on patient diseases.
• Coaching component: personalized coaching based on patient data.
• Data monitoring component: tracks health metrics.
• Analytics component: analyses data, identifies patterns, and optimizes treatment plans.

Essential Features of Digital Therapeutics

• Evidence-Based therapeutic interventions: DTx programs are based on clinical evidence ensuring high standards of efficacy and safety. Unlike general wellness apps, DTx interventions are grounded in scientific research.
• Medical and smart device integration: Incorporates wearables and handheld devices to monitor metrics like HbA1c, blood urea nitrogen, essential minerals, heart rate, O₂ saturation, ECG, etc., enabling personalized feedback and adjustments in real-time.
• Artificial intelligence: Plays a key role in analysing data, identifying patterns, and optimizing treatment plans for greater accuracy.
• Personalized health coaching: Provides lifestyle and behavioural guidance to complement medical treatments.
• Digital technologies: Uses cloud computing and mobile connectivity for scalable, efficient, real-time therapeutic delivery.

Pharma Approach to DTx

When pharmaceutical companies collaborate with digital therapeutics, their approach typically involves:

1. Around the pill: Developing digital therapeutic products that complement medications, addressing behavioural and lifestyle components that drugs alone cannot. This is especially useful as many blockbuster drugs lose patent protection and face generic competition.
2. Beyond the pill: Developing standalone digital therapeutic solutions, also referred to as monotherapy.