Review Article

Role of digital therapeutics and the changing future of

healthcare
Amit Dang1, Dimple Arora2, Pawan Rane3
Founder and CEO, KYT Adhere, Founder and CEO, MarksMan Healthcare Communications, Hyderabad, Telangana,
1

2
Co‑Founder, KYT Adhere, Co-Founder, MarksMan Healthcare Communications, Hyderabad, Telangana,
3
Co‑Founder, KYT Adhere, Head and Neck Oncosurgeon, Healthway Hospital, Goa, India

A bstract
With healthcare becoming digital, patients today are more empowered than ever before. As a result, digital health solutions have
become the need of the hour to keep up with an increasing number of empowered patients participating in their own treatment
decisions. Digital health encompasses various platforms and systems that apply technological solutions to enhance healthcare
delivery. Digital therapeutics (DTx) is one such category of digital health solutions that provides evidence‑based software‑driven
therapeutic interventions for the prevention and management of a medical disorder or disease. This review aims to provide a
comprehensive overview of DTx, its functions and applications in healthcare, and associated regulatory aspects, among others.

Keywords: App‑based healthcare, digital medicine, digital therapeutics, regulatory aspects

Introduction implementation of more efficient clinical trial designs (such

as adaptive designs and bioinformatics), the advancement of
Drug development is considered to be a lengthy, expensive, and quantifiable disease models, and the augmentation of drug
high‑risk venture in today’s world.[1] Despite massive investment manufacturing processes.[2] With concepts such as personalized
by global players, the overall research and development (R and D) and precision medicine taking the lead, the landscape of
productivity in the pharmaceutical and life sciences industry has healthcare is increasingly becoming more digital.
substantially declined across the world.[1] As a result, various
industry stakeholders, academia, and health regulatory authorities The world has witnessed the explosion of digital health over
are continuously trying to improve, encourage, and devise the last decade with the emergence of social media platforms,
the best scientific tools to modernize drug development. For smartphones and mobile applications, wearable devices,
instance, the US Food and Drugs Administration (USFDA), in cloud‑based data platforms, real‑world evidence studies, and the
an attempt to identify critical areas for scientific improvement, likes. As a consequence, general well‑being and health monitoring
is increasingly encouraging novel ideas. Examples of such ideas are gradually extending from being space‑bound activities
include‑ development and qualification of new biomarkers, restricted to hospitals and clinics to the widespread digital world
through various smartphone applications. In this context, the
Address for correspondence: Dr Amit Dang, term “Digital Health” applies to all the technologies that engage
Founder, KYT Adhere, Founder and CEO, MarksMan Healthcare
patients in their health and well‑being and includes concepts such
Communications, H. No 9‑1‑67, Plot no. 67, TNGO’s Colony,
Behind Q City, Financial District, Hyderabad ‑ 500 032, Telangana, as mobile health (mHealth), telehealth (i.e. telemedicine), smart
India. devices, sensors and wearable’s, health information technology,
E‑mail: [email protected] and personalized medicine.[3] Innovative models are being studied
Received: 17‑01‑2020 Revised: 12‑03‑2020 in the digitized health domain, utilizing open source engineering
Accepted: 23‑03‑2020 Published: 31-05-2020
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DOI: How to cite this article: Dang A, Arora D, Rane P. Role of digital
10.4103/jfmpc.jfmpc_105_20 therapeutics and the changing future of healthcare. J Family Med Prim
Care 2020;9:2207-13.

© 2020 Journal of Family Medicine and Primary Care | Published by Wolters Kluwer ‑ Medknow 2207
 Dang, et al.: Digital therapeutics and healthcare

and optimizing the potential of professionals from traditional “E‑patients” are patients who are “equipped, enabled,
healthcare settings. This emergent phenomenon within the digital empowered, and engaged in their health and healthcare
health sphere is called “Digital Therapeutics” (DTx).[3,4] decisions.”[14] Today, the number of e‑patients is on the rise.
They are better engaged and want to participate in informed
What is “Digital Therapeutics” (DTx)? decision‑making about their care. They expect informed answers
for their medical and health technology‑related questions from
Digital Therapeutics (DTx) is a subdivision of digital health, their physicians.[8] In such an aware world, the need for digital
which represents a collection of technologies, products, and health and related tools becomes inevitable.
services across healthcare and wellness industries. Sepah et al.,
in 2015, mentioned the term “digital therapeutics” for the first Relationship between Digital Health, Digital
time in their peer‑reviewed publication, and formally defined it
Medicine, and DTx
as, “evidence‑based behavioral treatments delivered online that
can increase accessibility and effectiveness of healthcare.”[5] Digital health can be broadly defined as fitting together healthcare
The Digital Therapeutics Alliance (DTA) defines the DTX as and technology. Differentiating between digital health, digital
“delivering evidence‑based therapeutic interventions to patients medicine, and DTx is essential to avoid confusion among digital
that are driven by software to prevent, manage, or treat a medical health stakeholders as well as the manufacturers and developers
disorder or disease. They are used independently or in concert of these products for better placement and utility of these
with medications, devices, or other therapies to optimize patient products in the market.[15] The relationship between these three
care and health outcomes.”[6] The DTA further elaborates that related terms is depicted in Figure 1.[15]
the products of DTx integrate advanced technology with the
best practices on design, clinical support, usability, and data Digital health acts as an umbrella entity that encompasses digital
security. These products are reviewed and approved by regulators medicine which includes DTx. Products categorized under all
to supplement the product claims regarding risk, efficacy, and these categories convey different levels of claims and risks.
intended use. The DTA also empowers all the stakeholders Moreover, their requirements for clinical evidence and regulatory
including patients, healthcare providers, and payers with clever oversight are different too. Digital health is a broad category
and easily available tools for approaching a variety of conditions comprising of technologies, platforms, and systems that engage
through data‑based interventions that are high quality, safe, and consumers for lifestyle, wellness, and health‑related purposes.
effective.[7] Digital health entities can capture, store, and transmit health data
to support clinical operations. Examples of digital health systems
The value of the global DTx market is estimated at USD include health information technologies, telehealth systems,
1.8 billion in 2018, which is expected to reach USD 7.1 billion by systems that use consumer health information, and clinical care
2025.[7] A recent report estimates the biggest applications for DTx administration tools, among others.
to be diabetes and weight loss shortly, with other applications
likely to be observed in conditions such as chronic obstructive
pulmonary disorder (COPD), developmental disorders (with
the use of computer games), and post-traumatic stress disorder
[PTSD, with the use of virtual reality (VR)].[8]

History of DTx
In 1995, Dr. Joseph Kvedar from Boston, USA, led a program
to learn the development and application of technology for
delivering care outside the traditional setup of a hospital or a
doctor’s office while suggesting the “one‑to‑many model of care.”
The idea was to expand the physicians’ scope by overcoming time,
place, and personnel limitations that restrict healthcare delivery
while also taking better care of patients with fewer resources by
providing access, convenience, and efficiency.[9] This attempt by
Dr. Kvedar could be attributed to being among the firsts made
by researchers in the digital health/DTx domain.

Evidence from literature depicting the use of digital products to

yield enhanced health outcomes dates as far back as 2000.[10] The
term “E‑patient” was coined by Dr. Tom Ferguson in 1999[11]
Figure 1: Difference between digital health, digital medicine, and
but gained awareness only after nearly a decade.[12] The formal DTx products concerning different risks and corresponding levels of
use of the term “DTx” has been noted since 2012.[13] necessary evidence and regulatory oversight.[5,15,16]

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 Dang, et al.: Digital therapeutics and healthcare

Digital medicine, on the other hand, consists of software or products. According to DTA, a DTx product not only has to
hardware products, typically supported by evidence, to measure be software‑driven and backed by evidence but should also
or intervene in the service of human health. Digital diagnostics, be able to prevent and manage a disease or a disorder.[9] DTx
digital biomarkers, and remote patient monitoring devices are a industry often refers to DTX applications as “clinically validated,”
few examples of digital medicines. “rigorous,” “focused,” and “FDA‑approved,”[19] depending on
the situation. Therapeutics mimicking the product development
DTx, as defined earlier, encompasses evidence‑based therapeutic path of pharmaceutical drugs are often referred to as “software
interventions that prevent, manage, or treat a medical disorder or as medicine” or “behavioral medicine in a digital format,” which
a disease.[6] Examples of DTx applications include digital sensors, indicates online or mobile delivery of skills‑based psychotherapy
wearable devices, certain VR, and artificial intelligence (AI) techniques. Diagnostic and therapeutic use of DTx can be
devices. categorized under one class while many companies are trying to
transform several behavioral interventions in digital formats. DTx
However, assuming that digital health products to have no relies exclusively on algorithms for its mechanism of action as
possible risks compared to digital medicine or DTx products well as the algorithmic information management, both of which
may be wrong. While the latter two rely on a higher degree of make it easier to generate, collate, and analyze the health data.[4]
evidence and regulatory oversight owing to greater clinical risk,
commercial digital health tools may carry their own set of risks. DTx often targets conditions that are poorly addressed by the
Therefore, the classification of products under digital health, healthcare system including chronic diseases or neurological
medicine, and therapeutics warrants further work to explore their disorders. Evidence is also emerging that shows the value of DTx
potential to enhance healthcare delivery as it may help all the in treating substance addiction. The USFDA recently approved a
stakeholders to thoroughly understand the purpose and clinical mobile application to help treat alcohol, marijuana, and cocaine
value of these products.[15] addiction, referring to the findings of clinical trials, which showed
abstinence in 40% patients using a DTx application for 3 months,
How Does DTx Work? compared with 17.6% of those who used standard therapy
alone.[20,21] Besides, DTx can often deliver relatively cost‑effective
DTx is a new category of applications that help treat diseases treatments when compared with traditional therapy by reducing
through changes in patient behavior and remote monitoring to demands on clinicians’ time.
yield enhanced and long‑term health outcomes. These applications
are devised to achieve favorable outcomes; for example, they can An area of great interest for the DTx industry is how these
encourage patients to adhere to a particular diet and exercise therapeutics can drive behavioral change at large scales. For
routine or drug regimens. The primary difference between instance, a 2002 study showed that a systematic behavioral
DTx and wellness applications is that the DTx applications are intervention targeting diet and exercise, through face‑to‑face
developed to target specific disease conditions, particularly major communication, substantially reduced people’s risk of developing
chronic diseases such as diabetes, cardiovascular conditions such type 2 diabetes.[22] This finding led to the development of similar
as hypertension, and pulmonary diseases like COPD.[17] The lifestyle‑change programs in the US, which are approved by
arrival of DTx is reforming the landscape for new medicines, the US Centers for Disease Control and Prevention (CDC).
product reimbursement, and regulatory surveillance. As a Subsequently, several DTx companies are developing ways to
result, new data‑sharing processes and payment models will be deliver such behavioral programs digitally to reach more people.
formed soon to incorporate these products into the broader For instance, one of the DTx companies in the US offers
treatment plans and regulatory structure for drug and device behavioral intervention for diabetes using a social network,
approvals. Recently, there has been a massive investment of USD which has a year‑long educational curriculum, personalized
12.5 billion in digital health ventures.[18] health coaching, and support through a small peer group. This
program also uses connected devices to track people’s nutrition,
Services available under DTx either complement and add on to activity, and weight by using tools such as hardware, software, and
the value of the traditional healthcare delivery system or have the human coaching over a long period.[23] The CDC also recognizes
potential to significantly replace the existing system. Examples for many such DTx‑based lifestyle‑change and diabetes‑prevention
the former include mobile applications and devices, which help programs.[9]
patients with reminders for time and dosage of medication, thus
improving their medication adherence. Examples for the latter An increasing number of DTx applications are emerging for the
are platforms that substitute medications with sensory stimuli treatment of mental health disorders. The digital application of
delivered via an application on the mobile device.[3] cognitive‑behavioral therapy (CBT) is showing promising results
in the treatment of depression and anxiety disorders. CBT is also
To distinguish DTx from other digital health innovations, the showing rapid diversification in other areas, e.g. substance abuse
DTA has elaborated on what makes a product classified as a disorders. Similar products for the treatment of schizophrenia
DTx. Even though DTx is a part of the digital health domain, it and insomnia are also under development.[24] For instance, an
is different from diagnostics, telehealth, and other digital health online self‑care program based on CBT for insomnia has shown

Journal of Family Medicine and Primary Care 2209 Volume 9 : Issue 5 : May 2020
 Dang, et al.: Digital therapeutics and healthcare

improvements in both insomnia symptoms as well as mental and list their applications with the USFDA. Examples of MMAs
well‑being.[25] under such enforcement discretion include[2,31]:
• Applications helping patients organize and track their health
DTx is also showing promising results in medication information
adherence by helping people optimize the benefits of • Applications providing easy access to information related to
conventional pharmaceutical therapies. For example, a DTx conditions or treatments, and
company in the US has developed a robot to nudge people • Applications helping patients self‑manage their disease or
to take their medications on time, intending to overcome condition (e.g. wellness applications) without providing
the challenges of medication nonadherence. This robot uses specific treatment.
artificial   intelligence (AI), paired with psychology modeling, to
tailor conversations to keep them adhering to the recommended Furthermore, with the need to modernize and encourage better
dosing regimens for a longer duration. This robot is currently innovation, the USFDA’s new “Digital Health Innovation Action
functional in therapy areas such as renal disease, rheumatoid Plan” outlines its effort to make high‑quality, safe, and effective
arthritis (RA), and congestive heart failure; the company is digital health products accessible to all patients.[19] However,
trying to adapt it for several other conditions.[26] Another its product category for many DTx applications leaves several
company has used a new approach to tackle medication grey areas, thus making it confusing for products unfit within a
nonadherence by developing a pill with an ingestible sensor, as specific risk category. These loopholes may lead to companies
small as the size of a grain of sand, and coated on either side overseeing the regulatory environment, especially now when
with copper and magnesium. After the pill is swallowed and hits the time is quite ripe for regulatory reforms. Owing to recent
the stomach connecting the two sides, it generates a signal for changes in regulations, the USFDA has started revamping
the sensor patch worn on the person’s skin. Finally, this process its evaluation pathway for digital health products. The action
sends a digital record a mobile app to the users, and with their plan further outlines the pathways for evaluating digital health
consent, to their healthcare providers. This sensor patch can products based on company characteristics instead of individual
also monitor the users’ activity, heart rate, sleep quality, and product efficacy.[19] Such an assessment is new and aimed at better
temperature, suggesting the ability to record people’s responses assessment of the repetitive nature of software development that
to the medication. The sensor currently monitors type 2 may proceed faster and inexpensively than carrying a product
diabetes, hypertension, and hepatitis C patients while further through prototyping procedures.[4]
studies are ongoing to determine its use in HIV prevention and
treatment as well as its potential use in oncology.[27] In a pilot While the new regulatory pathway lifts barriers to market for
study of 28 high‑risk hepatitis C patients incorporating this DTx products, in a way serving as an incentive for technological
technology showed 94% adherence with 26 patients cured.[28] innovation, regulatory authorities have not entirely developed
To track medication adherence in individuals living with bipolar specific methodologies to evaluate the companies formally. Thus,
II disorder and schizophrenia, another DTx company in the for many DTx entities, it is still not clear as to how their exclusive
US has developed an ingestible sensor.[29] algorithmic mechanisms will be evaluated.[4] Figure 2 represents
the USFDA’s regulatory framework for DTx.
In addition to the digital drugs and applications, DTx is also
increasingly incorporating VR technology owing to the recent With the proliferation of digital health, the need for scrutinizing
advancements paired with falling costs. The technology has various medical claims has become more critical than ever. With
been in use for over the last two decades but only for very few so many DTx products awaiting approval, it is becoming difficult
conditions and in specialist centers. It has shown significant for the regulators to keep up with the volume to ensure there are
use as a leading application in providing exposure therapy for no false claims. The DTA industry group expects new member
PTSD. Studies to assess its potential application in other areas, companies to implement certain principles and best practices, to
including depression, anxiety, phobias, obsessive‑compulsive reassure users of robust evidence and adherence to regulatory
disorder (OCD), eating disorders, addiction, and psychosis, clearance. These adherence standards consist of peer‑reviewed
among others, are also underway. The   VR technology in DTx publication of findings and clinically meaningful outcomes from
applies simulation to enable people to learn by experiencing trials, and appropriate protection for privacy and security.[9]
real‑world situations. For example, through VR, patients go into
situations and learn how to think, feel, and act differently.[30] DTx incorporation guidance by other regulators
The National Institute for Health and Care Excellence (NICE),
Regulatory Aspects of DTx together with NHS England and NHS Digital in the UK, is
also trying ways to accelerate the uptake of digital innovations.
DTx and USFDA As a result, NICE has recently published guidelines to help
T he USFDA considers DTx to be mobile medical manufacturers understand the required evidence.[32]
applications (MMAs). However, a substantial number of MMAs
come under the USFDA’s enforcement discretion, wherein they In a recent forum to address current market challenges and
do not need to submit premarket review applications or register opportunities in the field of DTx, the Academy of Managed

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 Dang, et al.: Digital therapeutics and healthcare

Although the widespread adoption of DTx may take longer than

the industry had hoped for, solutions to the main challenges
are evolving. The need for defining the standards of safety
and efficacy, for collaboration among stakeholders, and swifter
regulatory approval exists.[34]

DTx in India
Many Indian pharmaceutical companies are now modifying their
business models, strategies, product portfolio to enhance their
market presence to face the changing market dynamics better.
Companies have realized the tremendous value proposition
offered by DTx products/services. It is believed that DTx
services could reduce the drug manufacturing costs, while
adding value for insurers, too, allowing them to customize
Figure 2: The regulatory framework for digital therapeutics, as
implemented by the USFDA.[2] products based on the patients’ needs. However, DTx is still not
prevalent in India, and a few companies are planning to invest
Care Pharmacy (AMCP) set some guidelines for the entities to and venture into the DTx domain.[35] For instance, an Indian
qualify as DTx.[33] Apart from fitting into the DTA’s definition pharmaceutical giant is aiming to simplify the management of
of DTx, a product requires “approval as well as third‑party cardiovascular disorders using prescription drugs and AI‑driven
validation for safety and efficacy claims” by a regulatory digital therapies.[36]
authority, such as the USFDA. Furthermore, payers will base
their coverage decisions on a detailed assessment of the safety, DTx and Practice of Primary Care
efficacy, and utility of a product, along with the medical claim
DTx has the potential to improve primary care practice. A major
or function of the treatment. For instance, therapeutics aimed
advantage of DTx is that it offers the physicians an option
at replacing a pharmaceutical intervention may entail more
to provide treatment anywhere and anytime, transcending
evidence for coverage than those aimed at monitoring a condition
the physical borders of a clinic or a hospital. Thus, primary
or complementing a pharmaceutical intervention. Findings and care physicians can make the most out of the innovations in
recommendations from this forum will soon be published to technology to offer low‑cost treatment options that fill the current
help stakeholders find innovative and collaborative solutions for gaps in treatment, thereby encouraging patients to work together
adopting and utilizing DTx products in healthcare practice.[33] for achieving better health outcomes.[37] DTx applications can
help primary care physicians to make timely, informed, and
Barriers in the Adoption of DTx accurate clinical diagnoses and patient care decisions. Further,
DTx applications can enable primary care physicians to monitor
Notwithstanding significant solutions offered by DTX to poorly
and track response to the prescribed therapies, thereby aiding to
addressed conditions and substantial evidence proving their provide personalized treatment.[38] DTx applications can also be
clinical value, DTx entities have not yet significantly entered used by primary care physicians to monitor medication adherence
the mainstream healthcare. The two main obstacles to broader and thereby prevent complications.[39] There are DTx applications
adoption of DTx are[21]: which can assist the primary care physician in monitoring
• Difficulty in distinguishing DTx from the more general health chronic conditions such as diabetes. There are DTx programs
and well‑being applications in the general digital health market that can monitor blood sugar readings, medication intake, diet,
• Uneven incentives in the healthcare environment. and exercise, and the records can be reviewed by the primary
care physician for getting a holistic picture of the patient’s
With a massive investment of millions of dollars, more than health.[40] Efficacy of DTx applications in imparting behavioral
315,000 (as noted in 2017) health‑related applications are modifications required for lifestyle therapy in diabetes have been
currently available in the market.[34] For consumers as well studied and reported recently.[41] Similarly, DTx can help the
as medical professionals, it is tough to separate unproven or primary care physician to personalize the therapy and monitor
low‑value applications from those with proven therapeutic value. the outcomes in conditions such as depression and anxiety.[40]
Today, many digital therapies demand changes in healthcare
provider workflows, thus increasing physician burden by an Conclusion
overload of data and required interpretation. Moreover, payers
would prefer to offer reimbursement for digital therapy upon DTx is here to stay. It is a category of emerging treatment
achieving better clinical outcomes within a time frame, a vital approaches, ready to address chronic and other difficult‑to‑treat
thought considering the limitations of the US private health conditions. DTx is expected to expected to significantly influence
insurance market.[3] healthcare delivery and its consumption across the globe. These

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 Dang, et al.: Digital therapeutics and healthcare

therapies have the potential to change what the pharmaceutical 11. Tom Ferguson, M.D. [homepage on the internet]. Doctom.
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Journal of Family Medicine and Primary Care 2213 Volume 9 : Issue 5 : May 2020