Over 10 years experience of Traceability Solutions
By Pharmatrax Author
Category: Technoloy
No CommentsThe use of mobile technology and artificial intelligence (AI) has increased in all fields, and healthcare is not an exception. The uptake of digital health by both the patients and the healthcare professionals has picked up pace lately, especially in the wake of the COVID-19 pandemic. ‘Digital health’ is a vast term (1), comprising of electronic health records, telemedicine, online fitness programs, wellness applications, health monitoring gadgets, and digital therapeutics (DTx).
DTx, which is a subdomain under digital health, is defined by The Digital Therapeutics Alliance (DTA) (2) as a specialised branch of digital health which includes products that “deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders”.
DTx is an amalgamation of ‘digital’ and ‘therapeutics’ – medicines that leverage the ability of software to achieve therapeutic results. DTx products are akin to a ‘digital pill’: a medicine that is delivered digitally. In fact, DTx takes medicine ‘beyond the pill’, inducing psycho-behavioural changes through mobile apps.
DTx and Evidence: DTx is a form of therapeutic intervention that is prescribed by providers to a specific set of patients, with an intention to bring about a defined therapeutic effect. There is a stringent mechanism (3), based on regulatory guidelines by regulators such as the USFDA (1) to verify the credibility claims of DTx before they are offered to the patients, based on the various performance parameters.
DTx is different from wellness apps in that DTx is expected to provide evidence for its efficacy, unlike wellness apps. Since DTx is expected to be a form of therapy, the regulations4 surrounding DTx products are also more stringent than those with wellness apps. The very foundation of DTx products is based on ‘evidence’ of their efficacy in specific health disorders.(5) Indeed, there are many published studies that have documented improved outcomes using DTX for various chronic diseases such as diabetes (6) and hypertension (7), improving medication adherence (1), sleep disorders (8), substance abuse (9), and psychiatric disorders including depression. (10,11)
Evidence for DTx should ideally be originated through rigorously conducted randomized controlled trials (RCTs). The results of these RCTs which demonstrate efficacy in clinical parameters should ideally be published in peer-reviewed, reputed journals. Through these steps and more, the DTx products must clear regulatory requirements of efficacy and safety. Next, since DTx products generally involve collection and handling of sensitive patient data, there must be proof of adequate privacy and security protections. Finally, the DTx products must demonstrate meaningful value in the real-world setting as well, as demonstrated through real world evidence (RWE) studies.(1-3)
Importance of DTx Evidence to Stakeholders: The evidence generated to prove the clinical value of DTx is essential for all the stakeholders of DTx:
DTx aims to promote effectiveness of therapy by integrating data from multiple sources, applying advanced analytics, backed by evidence-based interventions, driven by continuous performance monitoring, directly interacting with the patient. These capabilities empower DTx to play a major role in healthcare transformation, building an integrated health ecosystem that can enable seamless transfer of data between different stakeholders, improving the quality of services, reducing costs and bring positive impact on public health.