“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.”

The Digital Therapeutics Alliance

---

A novel trend coming out of the fast-growing mobile health market, digital therapeutics are software products used to treat medical conditions. These products are designed to enable patients to take greater control over their care, similar to consumer wellness apps but with one key difference: Digital therapeutics focus on delivering clinical outcomes.

Particularly important in the definition above is that digital therapeutics are evidence-based, clinically evaluated software. However, while digital therapeutics are software-based, they are subject to the same regulatory oversight that traditional medicines undergo. This ensures that the product is safe to use, effective as well as has a clinical impact. They can also be prescribed independently or in concert with other medications or treatments to optimize patient outcomes.

---

First, some basic information on digital therapeutics – DTx products represent a new category of evidenced-based therapeutic technologies that support clinicians in delivering high-quality patient care. They address a range of disease states and provide a wide variety of software-based interventions. As defined by The Digital Therapeutics Alliance, DTx products are used independently or in concert with other medical therapies to:

• Directly impact disease state measures and clinical outcomes
• Expand access to safe, confidential, and effective medical treatments
• Provide therapies for previously un- or undertreated conditions
• Extend clinicians’ ability to care for patients
• Maximize patient engagement
• Close gaps in care
• Lower overall healthcare costs

Digital therapeutics are not at a conceptual stage but are well within the production and delivery stages. DTx targeting chronic medical and mental conditions have been developed over the past 15 to 20 years. The Digital Therapeutics Alliance even has a product library of DTx. This list can be essential as it helps differentiate DTx that physicians can prescribe from unregulated apps that overpopulate online app stores. The organization says that all products claiming to be digital therapeutic must adhere to these foundational principles:

---

Where are we today? – Extracting some examples from the product library referenced above gives us a sense of some diseases that can benefit from digital therapeutics.

One such product is Insula, a prescription-only software that assists type 2 diabetics in managing their condition. It recommends patients’ personalized insulin doses as well as acts as a coach in managing their diabetes. A randomized trial conducted in France showed that a precursor to the software helped improve glucose control compared with standard care.

Another example is Kaiku Health. The app supports cancer patients by allowing them to report potential symptoms that they might encounter; subsequently, it shares self-care instructions with them. Through Kaiku Health, patients can also message their care team. Studies have shown that such forms of digital monitoring lead to good patient adherence and satisfaction, as well as save time by reducing in-person visits or even phone consultations.

---

What are some of the challenges in implementing digital therapeutics? – Reimbursement and oversight are two significant areas of concern in health care systems, yet the regulatory landscape surrounding DTx is still in flux. The first question that must be answered is who is responsible for regulating DTx. The second is the relation of DTx to machine learning and whether changes in software or updated machine learning algorithms would require reapproval or new approvals. The Total Product Lifecycle approach currently under consideration by the FDA could address some of these concerns.

System-level challenges of DTx also include cybersecurity. DTx interfaces with, and is reliant on, multiple nonmedical entities, including internet, phone, and cloud storage service providers. There are no global answers to these issues, but patients and clinicians alike will be reluctant to transmit sensitive health data over unsecured channels. Moreover, reimbursement for DTx is moving slowly. Some private insurers pay for DTx as prescribed, but nationwide reimbursement codes remain uncommon.

A yet unexplored problem is adherence to DTx use once prescribed; as large-scale implementation becomes a reality, this issue will need to be appropriately addressed. “App burnout,” a phenomenon referring to the short-term use of apps, may be relevant to DTx as the prescribed length of time (i.e., weeks, months, years) increases.

---

My take on the future of digital therapeutics – Digital therapeutics are not just a fad. They have the potential to address unmet patient needs that traditional treatments and therapies have been unable to meet. The ability of companies that leverage digital therapeutics to address these gaps, in combination with the much faster product development timelines, could give them a significant advantage over traditional life sciences companies.

“Digital therapeutics are poised to shift medicine’s emphasis from physically dosed treatment regimens to end-to-end disease management based on behavioral change.”

The Digital Therapeutics Alliance

The potential of digital therapeutics has players across multiple industries weighing their options. Technology giants are interested in developing and acquiring digital therapeutics to enter and change the health care landscape. Payers are exploring whether digital therapeutics can deliver better quality of life and outcomes while maintaining or reducing the overall cost of care in specific disease areas while independently analyzing how patient data, which could be collected through such products, can be leveraged to inform coverage. Start-ups are coming up with innovative digital therapeutic ideas to attract investors.

Thus far, the main DTx developments have been delivering already proven treatments via electronic/software means. However, the future of DTx will likely include higher-order constructs and products that address comorbid disorders.

Leveraging DTx to improve mental and physical health is likely to be the biggest, paradigm-shifting change that medicine has known since the invention of antibiotics. However, how to apply these tools remains an area that needs operationalization. DTx is at the nexus of digital innovation and scalability/wide-scale use of digital interventions, with more investment and exciting developments on the horizon.