Digital therapeutics (DTx) is evidence-based and clinically trialled treatment or therapeutic interventions that utilises digital and often internet-based health technologies or high-quality software programs to prevent, manage, or treat a broad-spectrum of medical conditions or disease. They are used independently or in addition to medications, devices, or other therapies to optimise patient care and health outcomes.
DTx products incorporate advanced technology best practices relating to design, clinical evaluation, usability, and data security. They are held to the same standards of evidence and regulatory oversight as traditional medical treatments in that they are reviewed and certified by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
As outlined by the Digital Therapeutics Alliance, digital therapeutics must adhere to ten core principles to demonstrate product safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact. These principles are:
- Prevent, manage, or treat a medical disorder or disease
- Produce a medical intervention that is driven by software
- Incorporate design, manufacture, and quality best practices
- Engage end users in product development and usability processes
- Incorporate patient privacy and security protections
- Apply product deployment, management, and maintenance best practices
- Publish trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals
- Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use
- Make claims appropriate to clinical evaluation and regulatory status
- Collect, analyse, and apply real world evidence and/or product performance data
What is the value of DTx products?
Digital therapeutics are changing the face of healthcare through advanced technologies that offer increased accessibility and personalisation of treatment protocols. They are designed to empower patients, practitioners, and consumers by offering intelligent and accessible tools and meaningful solutions to address a diverse range of health conditions through high quality, safe, and effective data-driven interventions. It achieves this in the following ways:
- Allows greater patient access to clinically safe and effective therapies
- Provides treatment options for previously undiagnosed or underdiagnosed conditions
- Generates actionable, true insights that drive intelligent data-driven care
As a result, DTx has many benefits to patients as well as practitioners. Some of these benefits include:
- Optimising clinical and health outcomes
- Providing greater access to high quality therapies to underserved populations
- Building and growing a secure data repository for health information that is accessible through patient-owned devices
- Providing a highly engaging and user-friendly experience
- Providing meaningful results and insights on personalised treatment, goals and outcomes
- Offering at-home convenience and privacy
- Improving health literacy by transforming how patients understand, manage, and engage in their healthcare
- Optimising the time practitioners spend with their patients
- Improving healthcare communication between multiple care teams
- Lowering overall costs of care
What healthcare challenges do DTx address?
Digital therapeutics products can address critical gaps in current healthcare delivery systems and can eliminate these challenges associated with age, language, culture, geography, and socio-economic status by:
- Delivering treatment through modern accessible devices such as smartphones, tablets, and similar technologies
- Lowering stigma associated with the delivery of certain traditional therapies by offering at-home convenience and privacy
- Improving remote patient monitoring and enhancing practitioners’ ability to care for their patients
- Providing meaningful results and insights on personalised goals and health outcomes to patients and their practitioners
What does the future hold for DTx?
Digital therapeutics is here to stay and even grow. The digitalisation of healthcare is not just an update or a trend that providers are following, it has become a culture of its own. The advancements in the digital health component of therapeutics are enabling practitioners to deliver care to patients in a way they have ever before. The emerging practice is expected to significantly influence healthcare delivery and its consumption across the world and is ready to address chronic and other difficult-to-treat conditions.
The DTx market is expected to grow tenfold in the next three to five years, with a projected market value of $US9 billion by 2025. The continual advances in and the increasingly dominant role of mobile technology and artificial intelligence (AI) in our everyday lives have broadened the role of DTx in healthcare.
As a result, it’s creating greater opportunities to increase patients’ awareness of their health and their ability to play a more active role in managing their health condition, thereby creating greater compliance and adherence, which ultimately improves health outcomes and reduce the demands on healthcare systems compared to traditional medical interventions alone.
However, there still lies some challenges ahead in terms of how the technology is regulated, how healthcare providers respond to the paradigm shift, and how these technologies are reimbursed. But all-in-all the future is looking pretty exciting for digital healthcare.