Healthcare and Lifesciences
Role of Digital Therapeutics in Preventive Care
15 Mar 2023
Coming
to aid of traditional Rx, Digital therapeutics (DTx) are a new form of
preventive care that utilize technology to deliver evidence-based interventions
through software or digital devices. These interventions are designed to be
both clinically effective and user-friendly, with the ultimate goal of
improving health outcomes, increasing patient engagement, and lowering
healthcare costs. DTx is revolutionizing preventive care by providing safe,
evidence-based interventions that can help prevent or treat a variety of
medical conditions
How
do they work?
Digital
therapeutics have been proven effective in the management of both physical and
mental health conditions, including chronic ailments.
These
services are classified under the FDA's Software as a Medical Service (SaaMS)
and are delivered through software applications that can be accessed via
consumer devices like smartphones and tablets.
Digital
therapeutics operate by providing patients with health-related guidance,
behavioral suggestions, workout routines, and medication reminders. The
functionality of digital therapeutics is made possible through adaptive
algorithms, which progressively learn and enhance their performance with
exposure to diverse data and scenarios.
Digital
therapeutics (DTx) have been found to be effective in managing and treating a
wide range of ailments, including both physical and mental health conditions.
Here are some examples:
- Diabetes:
Digital therapeutics have been shown to be effective in managing diabetes,
helping patients track their blood sugar levels, monitor their diet and
exercise, and manage their medication.
- Hypertension:
Digital therapeutics can also help patients with high blood pressure monitor
their blood pressure levels, track their lifestyle habits, and manage their
medication.
- Substance
abuse disorders: DTx has been shown to be effective in treating substance abuse
disorders by providing cognitive-behavioral therapy (CBT) and motivational
enhancement therapy (MET) through mobile applications.
- Mental
health conditions: Digital therapeutics can help manage conditions like
depression, anxiety, and post-traumatic stress disorder (PTSD) by providing
cognitive-behavioral therapy, mindfulness-based stress reduction, and other
psychotherapy techniques through mobile apps.
- Respiratory
diseases: DTx has also been found to be effective in treating respiratory
diseases like asthma and chronic obstructive pulmonary disease (COPD) by
providing education, monitoring, and guidance through mobile applications.
- Sleep
disorders: Digital therapeutics have been shown to be effective in treating
sleep disorders like insomnia by providing cognitive-behavioral therapy and
sleep hygiene education through mobile applications.
How
are digital therapeutics beneficial?
The
significance of digital therapeutics lies in their ability to provide patients
with enhanced disease management, care, support, and information with
unparalleled convenience and consistency.
DTx
solutions offer medical practitioners a means of addressing gaps in treatment
and delivery that may be unaddressed by conventional methods. This presents
several advantages for patients, healthcare providers, and payers alike.
Some
of the benefits of digital therapeutics include:
Benefits
for patients
DTx
solutions offer patients personalized care and treatment plans that are
tailored to their specific needs. Since these solutions are accessible through
mobile devices, they increase the accessibility of healthcare and eliminate the
need for patients to travel to receive care.
Benefits
for healthcare providers –
Digital
therapeutics enable healthcare providers to expand their limited services and
reach a wider range of patients with limited resources.
Healthcare
providers who adopt and understand DTx solutions can meet patient needs without
having to travel or attend to patients individually due to their scalability.
These
digital solutions also improve the efficiency of healthcare delivery by
overcoming geographical barriers to access and facilitating care during natural
disasters such as tornadoes and hurricanes.
Benefits
for payers –
DTx
solutions reduce the cost of patient care for reimbursement schemes, regardless
of whether the payer is the government, insurance companies, or individuals.
Certain
aspects of digital therapeutics, such as behavior monitoring and management,
help patients reduce the frequency of medical visits, consultation fees, and
medication expenses.
Challenges
facing DTx
While
DTx has the potential to revolutionize the healthcare industry, there are
several challenges that must be addressed in order to fully realize its
potential.
Regulatory
Challenges:
One
of the biggest challenges for DTx is navigating regulatory frameworks. Digital
therapeutics are relatively new to the healthcare industry, and regulations
around them are still being developed. Companies developing DTx need to comply
with various regulations and requirements such as data privacy, data security,
and clinical evidence.
Access
to Technology:
DTx
relies on the use of digital technology, which can be a barrier to access for
some patients. Many patients may not have access to the necessary technology,
such as smartphones or tablets, or may not be comfortable using digital
technology.
Clinical
Validation:
DTx
needs to be clinically validated to prove their efficacy and safety. This
involves conducting clinical trials to demonstrate that DTx can produce
meaningful and lasting health outcomes. This process can be costly and
time-consuming, and companies need to navigate the complexities of conducting
clinical trials.
Adoption
by Healthcare Providers:
Healthcare providers are key stakeholders in the
adoption of DTx. However, they may be hesitant to adopt new technologies
without strong evidence of their efficacy and safety. Companies developing DTx
need to work with healthcare providers to ensure that they understand the
benefits of DTx and how to use them effectively.
User
Engagement
For
DTx to be effective, patients need to engage with it regularly. This can be a
challenge as many patients may not be motivated or find the interventions
difficult to use. Companies developing DTx need to focus on developing
interventions that are engaging and easy to use, and that can be integrated
into patients' daily lives.
Investments
in DTx in India
Digital
therapeutics (DTx) is an emerging field in India, and the investments in this
area are increasing as the potential of digital interventions in improving
healthcare outcomes is being realized. Some key areas of investment in DTx in
India include:
Telemedicine:
Telemedicine
is one of the key areas of investment in DTx in India. It involves the use of
digital technology to provide healthcare services remotely and can be
particularly useful in rural and remote areas where access to healthcare
services may be limited.
For
instance, in 2018, the Apollo Telemedicine Networking Foundation (ATNF)
launched a telemedicine initiative in the Indian state of Andhra Pradesh. The
initiative aims to provide high-quality healthcare services to people living in
remote and underserved areas of the state, using digital technology.
Under
the initiative, telemedicine centers have been set up in various locations
across the state, where patients can access medical consultations with doctors
and specialists using video conferencing technology. Patients can also receive
diagnostic tests and access electronic medical records, all from the same
location.
Chronic
disease management:
Digital
interventions for chronic disease management is another area of investment in
DTx in India. Digital tools such as mobile apps, wearable devices, and online
platforms can help patients to manage their chronic conditions more
effectively, and can also help healthcare providers to monitor their patients'
health remotely.
For
example, in 2021, the Indian digital therapeutics company Wellthy Therapeutics
raised $4 million in a funding round led by Saama Capital. The company plans to
use the funding to expand its digital interventions for chronic disease
management in India.
Wellthy
Therapeutics offers digital interventions for various chronic conditions,
including diabetes, hypertension, and cardiac rehabilitation. The company's
interventions use a combination of mobile apps, online platforms, and wearable
devices to help patients manage their condition more effectively and improve
their health outcomes.
One
of Wellthy Therapeutics' flagship products is the 'Wellthy Diabetes' app, which
uses machine learning algorithms to provide personalized guidance and support
to people with diabetes. The app has been clinically validated and has shown to
improve glycemic control and reduce the risk of diabetes-related complications.
With
the new funding, Wellthy Therapeutics plans to expand its reach to more
patients in India and develop new digital interventions for chronic disease
management. The company also plans to invest in research and development to
improve the effectiveness of its existing interventions and develop new ones.
Mental
health:
Mental
health is an area of growing concern in India, and there has been significant
investment in digital interventions for mental health. Digital tools such as
mobile apps and online platforms can help to improve access to mental health
services and provide support to those in need.
For
instance, in 2020, the Bangalore-based mental health startup, Wysa, raised $5.5
million in a funding round led by Boston-based W Health Ventures. The company
plans to use the funding to expand its digital interventions for mental health
in India.
Wysa
offers a mobile app-based chatbot that uses artificial intelligence (AI) to
provide personalized support and guidance for mental health issues such as
anxiety, depression, and stress. The chatbot interacts with users in a
conversational manner, using evidence-based techniques such as cognitive
behavioral therapy (CBT) and mindfulness.
The
Wysa chatbot has been clinically validated and has shown to be effective in
reducing symptoms of anxiety and depression. The company has also partnered
with several mental health professionals in India to provide more comprehensive
care to its users.
Public-private
partnerships:
The
Indian government has been partnering with private companies to develop and
deploy digital interventions in healthcare. These partnerships have helped to
accelerate the development and adoption of DTx in India.
In
2020, the National Health Authority (NHA) of India partnered with Google to
launch the 'National Health Stack' platform. The platform is designed to
support the implementation of India's flagship healthcare program, Ayushman
Bharat, which aims to provide health coverage to more than 500 million people
in India.
The
National Health Stack platform is a digital infrastructure that enables
interoperability of health data and applications. The platform uses open
standards and application programming interfaces (APIs) to enable seamless
exchange of data between various healthcare providers and systems.
Google
partnered with NHA to provide technical support and expertise in developing the
National Health Stack platform. Google also provided cloud computing services
and security infrastructure to ensure the privacy and security of health data.
The
National Health Stack platform has the potential to transform the healthcare
landscape in India by improving the efficiency and effectiveness of healthcare
delivery. The platform enables real-time monitoring and analysis of health
data, which can help in identifying health trends, predicting disease
outbreaks, and designing targeted interventions.
Best
Practices for Adopting DTx
Define
Clear Clinical Objectives:
The
first step in adopting DTx is to define clear clinical objectives. It is
important to identify the specific patient population and the clinical
conditions for which the digital intervention is intended. This will help in
selecting the appropriate digital intervention and measuring its clinical
efficacy.
Develop
Evidence-Based Interventions:
Digital
interventions should be evidence-based and should be validated through rigorous
clinical trials. The clinical trials should follow established protocols and
should be conducted in a diverse patient population.
Address
Regulatory and Legal Requirements:
Digital
interventions are subject to regulatory and legal requirements, and it is
important to address these requirements before adopting DTx. This includes
obtaining regulatory approval, complying with data privacy laws, and addressing
liability and reimbursement issues.
Ensure
Interoperability and Data Integration:
Digital
interventions should be designed to integrate with existing healthcare systems
and workflows. This includes ensuring interoperability with electronic health
records (EHRs) and other digital health tools, and integrating data from these
systems into the digital intervention.
Ensure
Usability and User Engagement:
Digital
interventions should be designed with user engagement in mind. This includes
ensuring ease of use, providing clear instructions and feedback, and
incorporating gamification and other engagement strategies.
Evaluate
and Monitor Outcomes:
Digital
interventions should be continuously evaluated and monitored to ensure their
effectiveness and clinical relevance. This includes monitoring patient
engagement, tracking clinical outcomes, and adjusting the intervention as
needed.
Final
Thoughts
In
conclusion, digital therapeutics (DTx) offer a promising new approach to
preventive care. By leveraging digital technologies such as mobile apps,
wearables, and online platforms, DTx can help individuals monitor and manage
their health in real time, identify potential health risks, and take proactive
steps to prevent disease. DTx can also help healthcare providers to better
engage with their patients, provide personalized care, and reduce healthcare
costs.
However,
the adoption of DTx in preventive care requires careful planning, validation,
and integration with existing healthcare systems. In particular, it is important
to establish clear clinical objectives, develop evidence-based interventions,
address regulatory and legal requirements, ensure interoperability and data
integration, and evaluate and monitor outcomes.
As
digital technologies continue to evolve and the need for preventive care
becomes increasingly important, the role of DTx in preventive care is likely to
expand. By embracing digital technologies and leveraging the power of data and
analytics, healthcare providers can improve the health and wellbeing of
individuals and communities, and ultimately help to build a healthier world.