Nupur Vasdev, Tanisha Gupta, Bhakti Pawar, Anoothi Bain, Rakesh Kumar Tekade
Highlights
- •Digital therapeutics (DTx) represents treatment modalities in which algorithms and software perform therapeutic functions.
- •DTx analyses personalized data and enables remote monitoring of patients.
- •Evidence-based software provides medical treatment options directly to individuals.
- •DTx also requires regulatory approval concerning safety and efficacy.
- •AI integration fortifies DTx performance.
Digital therapeutics (DTx) is a recently conceived idea in health care that aims to cure ailments and modify patient behavior by employing a range of digital technologies. Notably, when traditional medication is not entirely efficacious, DTx offers an innovative avenue for treatments linked to dysfunctional behaviors and lifestyle management. DTx involves extremely adaptable therapeutic devices that empower greater patient engagement in treating illness, using algorithms to collect, transfer and analyze the patient’s data. Efficient clinical monitoring and supervision at the individual level by remote access and algorithms for a range of diseases is made possible by integrating machine learning and artificial intelligence with DTx. There is a potentially large worldwide market for DTx owing to its convenient, personalized therapies.
Introduction
The term digital therapeutics (DTx) covers a range of technology, goods and services used in the fields of health care and wellness.(p1) The phrase ‘digital therapeutics’ was first used by Sepah et al. in 2015, and they described it as “behavioral treatments based on evidence delivered online that may enhance the effectiveness and accessibility of healthcare”.(p2) The emergence of DTx has opened a new frontier in the medical system by leveraging digital technologies to deliver evidence-based intervention for the management and treatment of disease. DTx is a novel concept that uses a range of digital technologies, including software, mobile applications, virtual reality (VR), artificial intelligence (AI) and wearable devices, which help to treat patients’ health conditions and alter their behavior. Patients can access evidence-based, experimentally proven therapeutic interventions through the newly formed DTx Alliance to prevent, control or diagnose a medical condition.(p3)
The widespread use of mobile devices in daily life makes it much more convenient to access a wide range of amenities and content, such as digital technologies related to diagnosis, prevention and treatment, particularly with a therapeutic focus. Advancements in technologies, the evolution of the regulatory landscape and the demand for accessibility and convenience have forced the rapid development of DTx. Conventional therapies cannot provide real-time data collection, remote access to symptoms or prescriptions and personalization of therapy in a precise manner. DTx provides these benefits by integrating traditional treatment methods. For example, in the management of diabetes, with the help of DTx, health professionals or patients can monitor their glucose level remotely and give treatment accordingly. Diabetes can be effectively managed with a variety of pharmaceutical therapies; however, with the adoption of DTx, patients now have access to continuous blood glucose monitoring. A wholly integrated closed-loop device has been designed to automatically check blood sugar levels and modify insulin dosage for patients with type 1 diabetes.(p4) Figure 1 illustrates the transformation of traditional treatment to digital treatment.
To address concerns about risk, efficacy and intended use, DTx should follow similar regulatory procedures to those mandated for prescription medicines.(p5) The DTx Alliance details how DTx must follow appropriate precautionary and effective protocols in randomly assigned clinical trials, take into account standard procedures for delivery and design, preserve the privacy and security of patients, publish clinically significant findings in peer-reviewed publications and get authorization from regulators to support claims regarding risk, effectiveness and intended application.(p3) The FDA in the United States and other regulatory bodies worldwide have been working hard to simplify their regulatory frameworks to facilitate the creation, assessment and, when necessary, approval of innovative digital therapies “at digital speed”. In the United States, DTx belongs to the FDA’s software-as-a-medical-device (SaMD) category and needs to get regulatory approval in a similar way to conventional medical devices and therapeutic pharmaceuticals (see https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd).
This review reconnoiters the expanding role and integration of AI in DTx, concentrating on its clinical outcomes for the health-care system. It discusses designing DTx for various applications such as diagnosis, prevention or therapy and covers authorized DTx technologies for several diseases. The review also highlights the potential challenges and ethical considerations associated with DTx.