Digital therapeutics: revolutionizing healthcare
- Digital therapeutics (DTx) is an evidence-based therapeutic intervention delivered to patients 1
- The commercialization and clinical use of digital therapeutics, based on digital technology, are growing, and the desire for expansion to new clinical domains is extremely high 2
- Real-world evidence-based validation should be enhanced by creating a system of collaboration between researchers, manufacturers, and governments 2
- There should be efficient technologies and legislative frameworks for removing DTx engagement barriers for the settlement of DTx to be successful 2
What is digital therapeutic?
Digital therapeutics is a subset of digital health, defined as therapeutic intervention delivered directly to the patient by a high-quality software program to prevent, monitor, treat, and manage any medical disease or disorder.
This evidence-based intervention by DTx can increase healthcare accessibility and effectiveness 3.
DTx and software as a medical device (SaMD) seem similar as many countries consider DTx a general medical device. The main difference between both is that SaMD is a generic term designed to be used for one or more than medical purposes; however, DTx is restricted to software that is used for evidence-based therapeutic intervention to manage disease or disorder 2.
Evolution of digital therapeutics
Since the 1970s, computational data approaches have revolutionized biological research, giving rise to disciplines like bioinformatics, systems biology, and computational genomics. Advances in artificial intelligence (AI), machine learning, and deep learning have enabled the interpretation of ‘big data’ in medicine, accelerating drug development and shifting healthcare focus from treatment to prevention. The term Digital therapeutics was mentioned first in 2015 by Sepah et al. and was formerly described as “evidence-based behavioral treatments given online that can improve healthcare accessibility and effectiveness”. 3
The strength of this approach lies in its dual nature. Algorithms learn from classical experiments, simulating changes in metabolic systems to understand potential side effects or more effective drug combinations. The digital health sector has seen rapid advancements, driven by its potential to revolutionize care delivery, making it more personalized, efficient, and patient-centric. The emergence of digital biomarkers and the rise of well-being and prevention in digital health are empowering individuals to access better care and personal health records. As the digital health landscape continues to evolve, It is clear that digital health is here to stay, disrupting the status quo and paving the way for a new era of health seekers. The future of digital health lies in its ability to adapt effectively to these health seekers’ needs, providing personalized, efficient care 4.
Classification and illustrative examples of digital therapeutics
There are four main categories of classification adopted by digital therapeutic alliances. These are based on its target product.
DTx intervention or treatment falls under one of the four categories mentioned below:
Category 1: Address medical conditions
Category 2: Prevent or manage a medical disease/disorder
Category 3: Medication optimization
Category 4: Treatment of any medical disorder/disease
Depending on the product’s intended use, each category of DTx products has different usage requirements.
For instance, the direct-to-consumer method can be used to enable patient access to category 1 DTx products: however, prescriptions are compulsion to provide category 4 DTx to any patients 5.
What is a digital platform?
A digital platform is defined as the collection of technologies and different applications for supporting the delivery of healthcare services 6.
The use of this platform is useful for both healthcare providers and consumers/patients and can reduce the pressure on the healthcare system.
A central infrastructure made up of digital health platforms offers facility-wide end-to-end solutions that can be facilitated by the production and exchange of useful information amongst all stakeholders in a healthcare system 7.
Digital therapeutics and pharma
Drug development is presently seen as a tedious, costly, and high-risk process. Despite massive investment from multinational corporations, the worldwide research and development (R&D) productivity of the pharmaceutical and life sciences sector has greatly declined 8.
The way medicines and therapies are developed, prescribed, and monitored today is largely due to the explosion of digital health. Integrating science with technology, behavioral psychology, and expert healthcare knowledge has changed the way of interaction with patients, data collection, and customized treatment. Whether standalone or “around-the-pill,” virtually every major pharmaceutical business is getting involved in digital therapeutic intervention.
Pharma companies are hedging their bets as more nations adopt legislative and regulatory measures that permit digital therapies (DTx) to reach more patients and enable payment. Others see the chance to support their existing activity or to start a new firm entirely, while it appears that some primarily want to dip a toe in the water to avoid being at a competitive disadvantage later.
Role of digital therapeutics in improving medication adherence
Digital Therapeutics (DTx) is spearheading a revolution in healthcare, particularly in augmenting medication adherence. It synergistically blends innovative technologies with behavioural sciences to optimize traditional pharmaceutical therapies.
A compelling example comes from a U.S. based DTx firm that has designed an AI-driven robot to ensure patients adhere to their medication schedules. Leveraging artificial intelligence and psychology modeling, it customizes conversations to encourage patients’ compliance, having been deployed in managing conditions such as renal disease, rheumatoid arthritis, and congestive heart failure. Furthermore, a novel DTx strategy for boosting medication adherence entails the development of a pill with an ingestible sensor. Roughly the size of a grain of sand, this sensor communicates with a patch on the patient’s skin to provide a digital record of medication intake, and it also tracks patient activity, heart rate, sleep quality, and temperature. This innovative approach currently monitors diseases such as type 2 diabetes and hypertension 1. Adding another dimension to this arena is Abbott’s a:care initiative. This program integrates digital tools with behavioral science to enable healthcare practitioners (HCPs) to support patients in building healthier habits.
In the context of chronic conditions like diabetes, DTx has proved to be a significant force in improving adherence. It enables behavioral modification through mechanisms like rewards, reminders, motivation, awareness enhancement, and gamification 9. The importance of these digital interventions was further highlighted in the wake of the COVID-19 crisis, with telehealth and virtual patient monitoring taking precedence over direct physician contact 10. With a wealth of smartphone applications exclusively designed to improve medication adherence, DTx is indeed ushering in a new era of patient-centered care 9.
This new opportunity in the pharma industry by digital health can improve patient outcome and their positive attitude toward medication adherence for chronic diseases, lifestyle, and behavioral-related diseases 3.
Find out more about some mobile application technologies and other technological advancements for medication adherence.
Mobile apps for enhancing adherence to chronic diseases
Looking into the Crystal-ball: Advances in technology for improving adherence
Advantages and challenges of digital therapeutics
A. Advantages:
- DTx has benefits beyond access to global intelligence technology, cost-effectiveness, and patient-centered care but also the response to diseases such as chronic, psychiatric, and neurological diseases that have not been properly treated in the traditional medical system. Hence the market DTx expects growth in value, expectation, and demand every day 2.
- Most of DTx’s core technologies have focused on apps for mobile and the web. The reason for this is user accessibility to smartphones is very high. Monitoring and feedback related to the treatment is easy to carry out, so it’s beneficial for improving adherence to the medicine and maximizing the effects of cognitive behavior therapy 2.
B. Challenges:
- The major challenge of DTx is the digital barrier for patients who do not have prior knowledge of digital devices. Therefore, prior training is recommended for the patients to understand digital devices and data security issues. It will be easy to train those patients who have digital devices and some level of cognitive ability to understand 2. Training for HCPs is equally important as digital therapeutics interventions are new in the healthcare field.
- Skilled and professionally trained assistance from trained HCPs is required to handle the mechanism of DTx as any mistakes at the time of its use can lead to affect a larger population at a single point in time.
- Furthermore, there is a risk that sensitive personal data may be leaked due to DTx’s retention of user information in digital form; therefore, additional preventative cyber security measures are needed 2.
- Language is another barrier for DTx 2.
Conclusion
Digital Therapeutics (DTx), a novel healthcare technique, has the potential to transform the treatment of chronic and complex diseases. It is critical for healthcare practitioners to recognize that DTx marks a substantial shift in patient care techniques around the world. With its many benefits and drawbacks, such as side effect control, patient monitoring, and privacy concerns, DTx necessitates a new set of clinical practice rules. It is more than just a drug-dispensing platform; it is a combination of digital services and pharmaceutical solutions that promotes strategic healthcare developments. As we stand at the vanguard of this shift, increased R&D investments and regulatory approvals highlight DTx’s enormous potential. As healthcare practitioners, we must adapt and interact with these advances to ensure the best possible patient care outcomes.
“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.” – Charles Darwin
References
1. Dang A, Arora D, Rane P. Role of digital therapeutics and the changing future of healthcare. J Family Med Prim Care. May 2020;9(5):2207-2213. doi:10.4103/jfmpc.jfmpc_105_20
2. Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med. Mar 10 2023;6(1):38. doi:10.1038/s41746-023-00777-z
3. Sepah SC, Jiang L, Peters AL. Long-term outcomes of a Web-based diabetes prevention program: 2-year results of a single-arm longitudinal study. J Med Internet Res. Apr 10 2015;17(4):e92. doi:10.2196/jmir.4052
4. Park SG-P, J.; Cohen, A.; Varga, Z.;. From treatment to prevention: The evolution of digital healthcare. Nature portfolio. 2019;573(7775)
5. Chung JY. Digital therapeutics and clinical pharmacology. Transl Clin Pharmacol. Mar 2019;27(1):6-11. doi:10.12793/tcp.2019.27.1.6
6. Eskandar HP, S. Digital Health Platform: Building a Digital Information Infrastructure (Infostructure) for Health. Handbook. World Health Organization. 2020:1-256.
7. Ibeneme S, Karamagi H, Muneene D, Goswami K, Chisaka N, Okeibunor J. Strengthening Health Systems Using Innovative Digital Health Technologies in Africa. Front Digit Health. 2022;4:854339. doi:10.3389/fdgth.2022.854339
8. Lendrem D, Senn SJ, Lendrem BC, Isaacs JD. R&D productivity rides again? Pharm Stat. Jan-Feb 2015;14(1):1-3. doi:10.1002/pst.1653
9. Ahmed I, Ahmad NS, Ali S, et al. Medication Adherence Apps: Review and Content Analysis. JMIR Mhealth Uhealth. Mar 16 2018;6(3):e62. doi:10.2196/mhealth.6432
10. Negreiro M. The rise of digital health technologies during the pandemic. European Parliamentary Research Service. 2021;PE 690.548:1-10.